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November 2021 – ICYMI
Gastroenterology
August 2021
How to perform a high-quality endoscopic submucosal dissection
Saito Y et al. Gastroenterology. 2021 Aug;161(2):405-10. doi: 10.1053/j.gastro.2021.05.051.
Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection: A network meta-analysis
Rokkas T et al. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012.
The optimal age to stop endoscopic surveillance of patients with Barrett’s esophagus based on sex and comorbidity: A comparative cost-effectiveness analysis
Omidvari AH et al. Gastroenterology. 2021 Aug;161(2):487-94.e4. doi: 10.1053/j.gastro.2021.05.003.
Development and validation of test for “leaky gut” small intestinal and colonic permeability using sugars in healthy adults
Khoshbin K et al. Gastroenterology. 2021 Aug;161(2):463-75.e13. doi: 10.1053/j.gastro.2021.04.020.
September 2021
Pregnancy and the working gastroenterologist: Perceptions, realities, and systemic challenges
David YN et al. Gastroenterology. 2021 Sep;161(3):756-60. doi: 10.1053/j.gastro.2021.05.053.
New drugs on the horizon for functional and motility gastrointestinal disorders
Camilleri M. Gastroenterology. 2021 Sep;161(3):761-4. doi: 10.1053/j.gastro.2021.04.079.
A randomized trial comparing the specific carbohydrate diet to a Mediterranean diet in adults with Crohn’s disease
Lewis JD et al. Gastroenterology. 2021 Sep;161(3):837-52.e9. doi: 10.1053/j.gastro.2021.05.047.
How to promote career advancement and gender equity for women in gastroenterology: a multifaceted approach
Chua SG et al. Gastroenterology. 2021 Sep;161(3):792-7. doi: 10.1053/j.gastro.2021.06.057.
October 2021
How to approach a patient with difficult-to-treat IBS
Chang L. Gastroenterology. 2021 Oct;161(4):1092-8.e3. doi: 10.1053/j.gastro.2021.07.034.
Early-age onset colorectal neoplasia in average-risk individuals undergoing screening colonoscopy: A systematic review and meta-analysis
Kolb JM et al. Gastroenterology. 2021 Oct;161(4):1145-55.e12. doi: 10.1053/j.gastro.2021.06.006.
Adalimumab subcutaneous in participants with ulcerative colitis (VARSITY)
Peyrin-Biroulet L et al. Gastroenterology. 2021 Oct;161(4):1156-67.e3. doi: 10.1053/j.gastro.2021.06.015.
Extraintestinal manifestations of inflammatory bowel disease: Current concepts, treatment, and implications for disease management
Rogler G et al. Gastroenterology. 2021 Oct;161(4):1118-32. doi: 10.1053/j.gastro.2021.07.042.
Clinical Gastroenterology and Hepatology
August 2021
Health equity and telemedicine in gastroenterology and hepatology
Wegermann K et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1516-9. doi: 10.1016/j.cgh.2021.04.024.
AGA Clinical Practice Update on evaluation and management of early complications after bariatric/metabolic surgery: Expert review
Kumbhari V et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1531-7. doi: 10.1016/j.cgh.2021.03.020.
Clinical, pathology, genetic, and molecular features of colorectal tumors in adolescents and adults 25 years or younger
de Voer RM et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1642-51.e8. doi: 10.1016/j.cgh.2020.06.034.
Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis
Deepak P et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1592-601.e3. doi: 10.1016/j.cgh.2020.06.050.
September 2021
Association of adenoma detection rate and adenoma characteristics with colorectal cancer mortality after screening colonoscopy
Waldmann E et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1890-8. doi: 10.1016/j.cgh.2021.04.023.
Prevalence and characteristics of abdominal pain in the United States
Lakhoo K et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1864-72.e5. doi: 10.1016/j.cgh.2020.06.065.
Model using clinical and endoscopic characteristics identifies patients at risk for eosinophilic esophagitis according to updated diagnostic guidelines
Cotton CC et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1824-34.e2. doi: 10.1016/j.cgh.2020.06.068.
October 2021
A high-yield approach to effective endoscopy teaching and assessment
Huang HZ et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):1999-2001. doi: 10.1016/j.cgh.2021.07.013.
2021 E/M code changes: Forecasted impacts to gastroenterology practices
Francis DL et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2002-5. doi: 10.1016/j.cgh.2021.07.008.
You can’t have one without the other: Innovation and ethical dilemmas in gastroenterology and hepatology
Couri T et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2015-9. doi: 10.1016/j.cgh.2020.05.024.
Psychiatric disorders in patients with a diagnosis of celiac disease during childhood from 1973 to 2016
Lebwohl B et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2093-101.e13. doi: 10.1016/j.cgh.2020.08.018.
Mast cell and eosinophil counts in gastric and duodenal biopsy specimens from patients with and without eosinophilic gastroenteritis
Reed CC et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2102-2111. doi: 10.1016/j.cgh.2020.08.013.
Cellular and Molecular Gastroenterology and Hepatology
Sex differences in the exocrine pancreas and associated diseases
Wang M et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):427-41. doi: 10.1016/j.jcmgh.2021.04.005.
Mesenteric neural crest cells are the embryological basis of skip segment Hirschsprung’s disease
Yu Q et al. Cell Mol Gastroenterol Hepatol. 2021;12(1):1-24. doi: 10.1016/j.jcmgh.2020.12.010.
Helicobacter pylori–induced rev-erbα fosters gastric bacteria colonization by impairing host innate and adaptive defense
Mao MY et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):395-425. doi: 10.1016/j.jcmgh.2021.02.013.
Techniques and Innovations in Gastrointestinal Endoscopy
Staying (mentally) healthy: The impact of COVID-19 on personal and professional lives
Alkandari A et al. Tech Innov Gastrointest Endosc. 2021;23(2):199-206. doi: 10.1016/j.tige.2021.01.003.
Establishing new endoscopic programs in the unit pitfalls and tips for success
Siddiqui UD. Tech Innov Gastrointest Endosc. 2021;23(3):263-7. doi: 10.1016/j.tige.2021.03.002.
Chief of endoscopy: Specific challenges to leading the team and running the unit
Michelle A. Anderson MA et al. Tech Innov Gastrointest Endosc. 2021;23(3):249-55. doi: 10.1016/j.tige.2021.03.004.
Safety in endoscopy for patients and healthcare workers During the COVID-19 pandemic
Lui RN. Tech Innov Gastrointest Endosc. 2021;23(2):170-178. doi: 10.1016/j.tige.2020.10.004.
Gastroenterology
August 2021
How to perform a high-quality endoscopic submucosal dissection
Saito Y et al. Gastroenterology. 2021 Aug;161(2):405-10. doi: 10.1053/j.gastro.2021.05.051.
Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection: A network meta-analysis
Rokkas T et al. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012.
The optimal age to stop endoscopic surveillance of patients with Barrett’s esophagus based on sex and comorbidity: A comparative cost-effectiveness analysis
Omidvari AH et al. Gastroenterology. 2021 Aug;161(2):487-94.e4. doi: 10.1053/j.gastro.2021.05.003.
Development and validation of test for “leaky gut” small intestinal and colonic permeability using sugars in healthy adults
Khoshbin K et al. Gastroenterology. 2021 Aug;161(2):463-75.e13. doi: 10.1053/j.gastro.2021.04.020.
September 2021
Pregnancy and the working gastroenterologist: Perceptions, realities, and systemic challenges
David YN et al. Gastroenterology. 2021 Sep;161(3):756-60. doi: 10.1053/j.gastro.2021.05.053.
New drugs on the horizon for functional and motility gastrointestinal disorders
Camilleri M. Gastroenterology. 2021 Sep;161(3):761-4. doi: 10.1053/j.gastro.2021.04.079.
A randomized trial comparing the specific carbohydrate diet to a Mediterranean diet in adults with Crohn’s disease
Lewis JD et al. Gastroenterology. 2021 Sep;161(3):837-52.e9. doi: 10.1053/j.gastro.2021.05.047.
How to promote career advancement and gender equity for women in gastroenterology: a multifaceted approach
Chua SG et al. Gastroenterology. 2021 Sep;161(3):792-7. doi: 10.1053/j.gastro.2021.06.057.
October 2021
How to approach a patient with difficult-to-treat IBS
Chang L. Gastroenterology. 2021 Oct;161(4):1092-8.e3. doi: 10.1053/j.gastro.2021.07.034.
Early-age onset colorectal neoplasia in average-risk individuals undergoing screening colonoscopy: A systematic review and meta-analysis
Kolb JM et al. Gastroenterology. 2021 Oct;161(4):1145-55.e12. doi: 10.1053/j.gastro.2021.06.006.
Adalimumab subcutaneous in participants with ulcerative colitis (VARSITY)
Peyrin-Biroulet L et al. Gastroenterology. 2021 Oct;161(4):1156-67.e3. doi: 10.1053/j.gastro.2021.06.015.
Extraintestinal manifestations of inflammatory bowel disease: Current concepts, treatment, and implications for disease management
Rogler G et al. Gastroenterology. 2021 Oct;161(4):1118-32. doi: 10.1053/j.gastro.2021.07.042.
Clinical Gastroenterology and Hepatology
August 2021
Health equity and telemedicine in gastroenterology and hepatology
Wegermann K et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1516-9. doi: 10.1016/j.cgh.2021.04.024.
AGA Clinical Practice Update on evaluation and management of early complications after bariatric/metabolic surgery: Expert review
Kumbhari V et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1531-7. doi: 10.1016/j.cgh.2021.03.020.
Clinical, pathology, genetic, and molecular features of colorectal tumors in adolescents and adults 25 years or younger
de Voer RM et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1642-51.e8. doi: 10.1016/j.cgh.2020.06.034.
Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis
Deepak P et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1592-601.e3. doi: 10.1016/j.cgh.2020.06.050.
September 2021
Association of adenoma detection rate and adenoma characteristics with colorectal cancer mortality after screening colonoscopy
Waldmann E et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1890-8. doi: 10.1016/j.cgh.2021.04.023.
Prevalence and characteristics of abdominal pain in the United States
Lakhoo K et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1864-72.e5. doi: 10.1016/j.cgh.2020.06.065.
Model using clinical and endoscopic characteristics identifies patients at risk for eosinophilic esophagitis according to updated diagnostic guidelines
Cotton CC et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1824-34.e2. doi: 10.1016/j.cgh.2020.06.068.
October 2021
A high-yield approach to effective endoscopy teaching and assessment
Huang HZ et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):1999-2001. doi: 10.1016/j.cgh.2021.07.013.
2021 E/M code changes: Forecasted impacts to gastroenterology practices
Francis DL et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2002-5. doi: 10.1016/j.cgh.2021.07.008.
You can’t have one without the other: Innovation and ethical dilemmas in gastroenterology and hepatology
Couri T et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2015-9. doi: 10.1016/j.cgh.2020.05.024.
Psychiatric disorders in patients with a diagnosis of celiac disease during childhood from 1973 to 2016
Lebwohl B et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2093-101.e13. doi: 10.1016/j.cgh.2020.08.018.
Mast cell and eosinophil counts in gastric and duodenal biopsy specimens from patients with and without eosinophilic gastroenteritis
Reed CC et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2102-2111. doi: 10.1016/j.cgh.2020.08.013.
Cellular and Molecular Gastroenterology and Hepatology
Sex differences in the exocrine pancreas and associated diseases
Wang M et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):427-41. doi: 10.1016/j.jcmgh.2021.04.005.
Mesenteric neural crest cells are the embryological basis of skip segment Hirschsprung’s disease
Yu Q et al. Cell Mol Gastroenterol Hepatol. 2021;12(1):1-24. doi: 10.1016/j.jcmgh.2020.12.010.
Helicobacter pylori–induced rev-erbα fosters gastric bacteria colonization by impairing host innate and adaptive defense
Mao MY et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):395-425. doi: 10.1016/j.jcmgh.2021.02.013.
Techniques and Innovations in Gastrointestinal Endoscopy
Staying (mentally) healthy: The impact of COVID-19 on personal and professional lives
Alkandari A et al. Tech Innov Gastrointest Endosc. 2021;23(2):199-206. doi: 10.1016/j.tige.2021.01.003.
Establishing new endoscopic programs in the unit pitfalls and tips for success
Siddiqui UD. Tech Innov Gastrointest Endosc. 2021;23(3):263-7. doi: 10.1016/j.tige.2021.03.002.
Chief of endoscopy: Specific challenges to leading the team and running the unit
Michelle A. Anderson MA et al. Tech Innov Gastrointest Endosc. 2021;23(3):249-55. doi: 10.1016/j.tige.2021.03.004.
Safety in endoscopy for patients and healthcare workers During the COVID-19 pandemic
Lui RN. Tech Innov Gastrointest Endosc. 2021;23(2):170-178. doi: 10.1016/j.tige.2020.10.004.
Gastroenterology
August 2021
How to perform a high-quality endoscopic submucosal dissection
Saito Y et al. Gastroenterology. 2021 Aug;161(2):405-10. doi: 10.1053/j.gastro.2021.05.051.
Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection: A network meta-analysis
Rokkas T et al. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012.
The optimal age to stop endoscopic surveillance of patients with Barrett’s esophagus based on sex and comorbidity: A comparative cost-effectiveness analysis
Omidvari AH et al. Gastroenterology. 2021 Aug;161(2):487-94.e4. doi: 10.1053/j.gastro.2021.05.003.
Development and validation of test for “leaky gut” small intestinal and colonic permeability using sugars in healthy adults
Khoshbin K et al. Gastroenterology. 2021 Aug;161(2):463-75.e13. doi: 10.1053/j.gastro.2021.04.020.
September 2021
Pregnancy and the working gastroenterologist: Perceptions, realities, and systemic challenges
David YN et al. Gastroenterology. 2021 Sep;161(3):756-60. doi: 10.1053/j.gastro.2021.05.053.
New drugs on the horizon for functional and motility gastrointestinal disorders
Camilleri M. Gastroenterology. 2021 Sep;161(3):761-4. doi: 10.1053/j.gastro.2021.04.079.
A randomized trial comparing the specific carbohydrate diet to a Mediterranean diet in adults with Crohn’s disease
Lewis JD et al. Gastroenterology. 2021 Sep;161(3):837-52.e9. doi: 10.1053/j.gastro.2021.05.047.
How to promote career advancement and gender equity for women in gastroenterology: a multifaceted approach
Chua SG et al. Gastroenterology. 2021 Sep;161(3):792-7. doi: 10.1053/j.gastro.2021.06.057.
October 2021
How to approach a patient with difficult-to-treat IBS
Chang L. Gastroenterology. 2021 Oct;161(4):1092-8.e3. doi: 10.1053/j.gastro.2021.07.034.
Early-age onset colorectal neoplasia in average-risk individuals undergoing screening colonoscopy: A systematic review and meta-analysis
Kolb JM et al. Gastroenterology. 2021 Oct;161(4):1145-55.e12. doi: 10.1053/j.gastro.2021.06.006.
Adalimumab subcutaneous in participants with ulcerative colitis (VARSITY)
Peyrin-Biroulet L et al. Gastroenterology. 2021 Oct;161(4):1156-67.e3. doi: 10.1053/j.gastro.2021.06.015.
Extraintestinal manifestations of inflammatory bowel disease: Current concepts, treatment, and implications for disease management
Rogler G et al. Gastroenterology. 2021 Oct;161(4):1118-32. doi: 10.1053/j.gastro.2021.07.042.
Clinical Gastroenterology and Hepatology
August 2021
Health equity and telemedicine in gastroenterology and hepatology
Wegermann K et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1516-9. doi: 10.1016/j.cgh.2021.04.024.
AGA Clinical Practice Update on evaluation and management of early complications after bariatric/metabolic surgery: Expert review
Kumbhari V et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1531-7. doi: 10.1016/j.cgh.2021.03.020.
Clinical, pathology, genetic, and molecular features of colorectal tumors in adolescents and adults 25 years or younger
de Voer RM et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1642-51.e8. doi: 10.1016/j.cgh.2020.06.034.
Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis
Deepak P et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1592-601.e3. doi: 10.1016/j.cgh.2020.06.050.
September 2021
Association of adenoma detection rate and adenoma characteristics with colorectal cancer mortality after screening colonoscopy
Waldmann E et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1890-8. doi: 10.1016/j.cgh.2021.04.023.
Prevalence and characteristics of abdominal pain in the United States
Lakhoo K et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1864-72.e5. doi: 10.1016/j.cgh.2020.06.065.
Model using clinical and endoscopic characteristics identifies patients at risk for eosinophilic esophagitis according to updated diagnostic guidelines
Cotton CC et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1824-34.e2. doi: 10.1016/j.cgh.2020.06.068.
October 2021
A high-yield approach to effective endoscopy teaching and assessment
Huang HZ et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):1999-2001. doi: 10.1016/j.cgh.2021.07.013.
2021 E/M code changes: Forecasted impacts to gastroenterology practices
Francis DL et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2002-5. doi: 10.1016/j.cgh.2021.07.008.
You can’t have one without the other: Innovation and ethical dilemmas in gastroenterology and hepatology
Couri T et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2015-9. doi: 10.1016/j.cgh.2020.05.024.
Psychiatric disorders in patients with a diagnosis of celiac disease during childhood from 1973 to 2016
Lebwohl B et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2093-101.e13. doi: 10.1016/j.cgh.2020.08.018.
Mast cell and eosinophil counts in gastric and duodenal biopsy specimens from patients with and without eosinophilic gastroenteritis
Reed CC et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2102-2111. doi: 10.1016/j.cgh.2020.08.013.
Cellular and Molecular Gastroenterology and Hepatology
Sex differences in the exocrine pancreas and associated diseases
Wang M et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):427-41. doi: 10.1016/j.jcmgh.2021.04.005.
Mesenteric neural crest cells are the embryological basis of skip segment Hirschsprung’s disease
Yu Q et al. Cell Mol Gastroenterol Hepatol. 2021;12(1):1-24. doi: 10.1016/j.jcmgh.2020.12.010.
Helicobacter pylori–induced rev-erbα fosters gastric bacteria colonization by impairing host innate and adaptive defense
Mao MY et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):395-425. doi: 10.1016/j.jcmgh.2021.02.013.
Techniques and Innovations in Gastrointestinal Endoscopy
Staying (mentally) healthy: The impact of COVID-19 on personal and professional lives
Alkandari A et al. Tech Innov Gastrointest Endosc. 2021;23(2):199-206. doi: 10.1016/j.tige.2021.01.003.
Establishing new endoscopic programs in the unit pitfalls and tips for success
Siddiqui UD. Tech Innov Gastrointest Endosc. 2021;23(3):263-7. doi: 10.1016/j.tige.2021.03.002.
Chief of endoscopy: Specific challenges to leading the team and running the unit
Michelle A. Anderson MA et al. Tech Innov Gastrointest Endosc. 2021;23(3):249-55. doi: 10.1016/j.tige.2021.03.004.
Safety in endoscopy for patients and healthcare workers During the COVID-19 pandemic
Lui RN. Tech Innov Gastrointest Endosc. 2021;23(2):170-178. doi: 10.1016/j.tige.2020.10.004.
Lupin recalls irbesartan and hydrochlorothiazide/irbesartan tablets
Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.
“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”
Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”
The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.
Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.
Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.
The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.
Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.
“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”
Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”
The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.
Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.
Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.
The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.
Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.
“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”
Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”
The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.
Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.
Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.
The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.
Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
COVID-19, yes, but so much more
Nearly 2 years into the pandemic, all things COVID-19 will of course be a major focus at the annual meeting of the American College of Chest Physicians, held virtually this year.
“During the pandemic, critical care has been at the forefront of what people are interested in,” said CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford.
“There is so much volume in critical care units that people have interest in anything related to critical care, including infectious diseases and disaster management in critical care,” he said in an interview.
Sessions at this year’s meeting that have a COVID-19 theme will focus on care of both patients and caregivers. Multiple symposiums, oral abstracts, scientific posters, and case reports will focus on clinical aspects of SARS-CoV-2 infections and COVID-19, including complications such as ventilator-associated and hospital-acquired pneumonia, a session called “Viruses, Variants, Vaccines, and Virulence: The Present and Future of COVID-19,” and support of patients and families.
Other presentations will focus on how COVID-19 has affected lung cancer screening, outpatient practices, pulmonary care, and sleep medicine.
Importantly, the meeting will include sessions focusing on the mental, physical, and social health of clinicians, especially those on the front lines in critical care and intensive care units. There will be sessions on how to recognize and avoid burnout, practice mental health awareness, and take time for self-care.
Presidential Honor Lecturer Curtis N. Sessler, MD, Master FCCP, FCCM, of Virginia Commonwealth University, Richmond, with give a talk titled, “Navigating the Road to Well-Being in the ICU.”
Empathy and diversity
Program cochair David Zielinski, MD, FCCP, of Montreal Children’s Hospital, Quebec, told this news organization that the COVID-19 pandemic has brought into even starker contrast inequities in patient care and in the health care system at large.
“This is a subject people are very keen about right now, whether it’s about how providers are treated, opportunities for improvement, or correcting inequities in outcomes for patients,” he said in an interview.
The program doesn’t shy away from the controversy, either, with a session provocatively titled, “Racism in Health Care: The Fuel That Lit the COVID-19 Fire.”
Keynote speaker Demondes Haynes, MD, FCCP, professor of medicine and associate dean of admissions at the University of Mississippi, Jackson, will speak on the importance of empathy in physician-patient communications and on ways to create a more diverse and inclusive workforce in medicine.
Beyond COVID-19
CHEST 2021 will include important information for sleep medicine physicians, including the latest news regarding an equipment recall affecting one of the two major manufacturers of continuous positive airway pressure devices.
“This has caused a lot of angst among sleep physicians and patients, and there are not enough devices to replace them,” Dr. Zielinski said.
“People who are on home ventilators are also affected by this recall,” Dr. Carroll added. “The population of patients who have sleep apnea is much greater than the population who are on home ventilators, but patients who are on home ventilators need it to save their lives.”
The meeting will include informative sessions summarizing U.S. and European asthma guidelines published over the past 2 years, as well as pending guidelines from the American College of Chest Physicians on venous thromboembolism and lung cancer screening.
Additional topics of importance include chronic obstructive pulmonary disease, interstitial lung disease, asthma management, acute respiratory failure in special populations, new therapies and strategies for treating tuberculosis, and many others.
There will be skill-polishing simulation sessions designed to help clinicians connect with experts in the field, update their knowledge, and sharpen their technique.
Fun and games
In addition to the serious subjects, CHEST 2021 attendees will have the chance to network with colleagues and friends and enjoy online games, including the 20th annual CHEST Challenge, which will pit teams of fellows-in-training from the Interfaith Medical Center, in Brooklyn, New York; the State University of New York, in Buffalo; and the Ohio State University Medical Center, in Columbus, in a Jeopardy!-style battle of wits and medical knowledge.
Close to 7,000 registrants from around the world took part in last year’s CHEST annual meeting, and a similar number is expected for this year’s edition, Dr. Carroll and Dr. Zielinski said.
A version of this article first appeared on Medscape.com.
Nearly 2 years into the pandemic, all things COVID-19 will of course be a major focus at the annual meeting of the American College of Chest Physicians, held virtually this year.
“During the pandemic, critical care has been at the forefront of what people are interested in,” said CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford.
“There is so much volume in critical care units that people have interest in anything related to critical care, including infectious diseases and disaster management in critical care,” he said in an interview.
Sessions at this year’s meeting that have a COVID-19 theme will focus on care of both patients and caregivers. Multiple symposiums, oral abstracts, scientific posters, and case reports will focus on clinical aspects of SARS-CoV-2 infections and COVID-19, including complications such as ventilator-associated and hospital-acquired pneumonia, a session called “Viruses, Variants, Vaccines, and Virulence: The Present and Future of COVID-19,” and support of patients and families.
Other presentations will focus on how COVID-19 has affected lung cancer screening, outpatient practices, pulmonary care, and sleep medicine.
Importantly, the meeting will include sessions focusing on the mental, physical, and social health of clinicians, especially those on the front lines in critical care and intensive care units. There will be sessions on how to recognize and avoid burnout, practice mental health awareness, and take time for self-care.
Presidential Honor Lecturer Curtis N. Sessler, MD, Master FCCP, FCCM, of Virginia Commonwealth University, Richmond, with give a talk titled, “Navigating the Road to Well-Being in the ICU.”
Empathy and diversity
Program cochair David Zielinski, MD, FCCP, of Montreal Children’s Hospital, Quebec, told this news organization that the COVID-19 pandemic has brought into even starker contrast inequities in patient care and in the health care system at large.
“This is a subject people are very keen about right now, whether it’s about how providers are treated, opportunities for improvement, or correcting inequities in outcomes for patients,” he said in an interview.
The program doesn’t shy away from the controversy, either, with a session provocatively titled, “Racism in Health Care: The Fuel That Lit the COVID-19 Fire.”
Keynote speaker Demondes Haynes, MD, FCCP, professor of medicine and associate dean of admissions at the University of Mississippi, Jackson, will speak on the importance of empathy in physician-patient communications and on ways to create a more diverse and inclusive workforce in medicine.
Beyond COVID-19
CHEST 2021 will include important information for sleep medicine physicians, including the latest news regarding an equipment recall affecting one of the two major manufacturers of continuous positive airway pressure devices.
“This has caused a lot of angst among sleep physicians and patients, and there are not enough devices to replace them,” Dr. Zielinski said.
“People who are on home ventilators are also affected by this recall,” Dr. Carroll added. “The population of patients who have sleep apnea is much greater than the population who are on home ventilators, but patients who are on home ventilators need it to save their lives.”
The meeting will include informative sessions summarizing U.S. and European asthma guidelines published over the past 2 years, as well as pending guidelines from the American College of Chest Physicians on venous thromboembolism and lung cancer screening.
Additional topics of importance include chronic obstructive pulmonary disease, interstitial lung disease, asthma management, acute respiratory failure in special populations, new therapies and strategies for treating tuberculosis, and many others.
There will be skill-polishing simulation sessions designed to help clinicians connect with experts in the field, update their knowledge, and sharpen their technique.
Fun and games
In addition to the serious subjects, CHEST 2021 attendees will have the chance to network with colleagues and friends and enjoy online games, including the 20th annual CHEST Challenge, which will pit teams of fellows-in-training from the Interfaith Medical Center, in Brooklyn, New York; the State University of New York, in Buffalo; and the Ohio State University Medical Center, in Columbus, in a Jeopardy!-style battle of wits and medical knowledge.
Close to 7,000 registrants from around the world took part in last year’s CHEST annual meeting, and a similar number is expected for this year’s edition, Dr. Carroll and Dr. Zielinski said.
A version of this article first appeared on Medscape.com.
Nearly 2 years into the pandemic, all things COVID-19 will of course be a major focus at the annual meeting of the American College of Chest Physicians, held virtually this year.
“During the pandemic, critical care has been at the forefront of what people are interested in,” said CHEST 2021 program cochair Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford.
“There is so much volume in critical care units that people have interest in anything related to critical care, including infectious diseases and disaster management in critical care,” he said in an interview.
Sessions at this year’s meeting that have a COVID-19 theme will focus on care of both patients and caregivers. Multiple symposiums, oral abstracts, scientific posters, and case reports will focus on clinical aspects of SARS-CoV-2 infections and COVID-19, including complications such as ventilator-associated and hospital-acquired pneumonia, a session called “Viruses, Variants, Vaccines, and Virulence: The Present and Future of COVID-19,” and support of patients and families.
Other presentations will focus on how COVID-19 has affected lung cancer screening, outpatient practices, pulmonary care, and sleep medicine.
Importantly, the meeting will include sessions focusing on the mental, physical, and social health of clinicians, especially those on the front lines in critical care and intensive care units. There will be sessions on how to recognize and avoid burnout, practice mental health awareness, and take time for self-care.
Presidential Honor Lecturer Curtis N. Sessler, MD, Master FCCP, FCCM, of Virginia Commonwealth University, Richmond, with give a talk titled, “Navigating the Road to Well-Being in the ICU.”
Empathy and diversity
Program cochair David Zielinski, MD, FCCP, of Montreal Children’s Hospital, Quebec, told this news organization that the COVID-19 pandemic has brought into even starker contrast inequities in patient care and in the health care system at large.
“This is a subject people are very keen about right now, whether it’s about how providers are treated, opportunities for improvement, or correcting inequities in outcomes for patients,” he said in an interview.
The program doesn’t shy away from the controversy, either, with a session provocatively titled, “Racism in Health Care: The Fuel That Lit the COVID-19 Fire.”
Keynote speaker Demondes Haynes, MD, FCCP, professor of medicine and associate dean of admissions at the University of Mississippi, Jackson, will speak on the importance of empathy in physician-patient communications and on ways to create a more diverse and inclusive workforce in medicine.
Beyond COVID-19
CHEST 2021 will include important information for sleep medicine physicians, including the latest news regarding an equipment recall affecting one of the two major manufacturers of continuous positive airway pressure devices.
“This has caused a lot of angst among sleep physicians and patients, and there are not enough devices to replace them,” Dr. Zielinski said.
“People who are on home ventilators are also affected by this recall,” Dr. Carroll added. “The population of patients who have sleep apnea is much greater than the population who are on home ventilators, but patients who are on home ventilators need it to save their lives.”
The meeting will include informative sessions summarizing U.S. and European asthma guidelines published over the past 2 years, as well as pending guidelines from the American College of Chest Physicians on venous thromboembolism and lung cancer screening.
Additional topics of importance include chronic obstructive pulmonary disease, interstitial lung disease, asthma management, acute respiratory failure in special populations, new therapies and strategies for treating tuberculosis, and many others.
There will be skill-polishing simulation sessions designed to help clinicians connect with experts in the field, update their knowledge, and sharpen their technique.
Fun and games
In addition to the serious subjects, CHEST 2021 attendees will have the chance to network with colleagues and friends and enjoy online games, including the 20th annual CHEST Challenge, which will pit teams of fellows-in-training from the Interfaith Medical Center, in Brooklyn, New York; the State University of New York, in Buffalo; and the Ohio State University Medical Center, in Columbus, in a Jeopardy!-style battle of wits and medical knowledge.
Close to 7,000 registrants from around the world took part in last year’s CHEST annual meeting, and a similar number is expected for this year’s edition, Dr. Carroll and Dr. Zielinski said.
A version of this article first appeared on Medscape.com.
FROM CHEST 2021
QI reduces daily labs and promotes sleep-friendly lab timing
Background: Daily labs are often unnecessary on clinically stable inpatients. Additionally, daily labs are frequently drawn very early in the morning, resulting in sleep disruptions. No prior studies have attempted an EHR-based intervention to simultaneously improve both frequency and timing of labs.
Study design: Quality improvement project.
Setting: Resident and hospitalist services at a single academic medical center.
Synopsis: After surveying providers about lab-ordering preferences, an EHR shortcut and visual reminder were built to facilitate labs being ordered every 48 hours at 6 a.m. (rather than daily at 4 a.m.). Results included 26.3% fewer routine lab draws per patient-day per week, and a significant increase in sleep-friendly lab order utilization per encounter per week on both resident services (intercept, 1.03; standard error, 0.29; P < .001) and hospitalist services (intercept, 1.17; SE, .50; P = .02).
Bottom line: An intervention consisting of physician education and an EHR tool reduced daily lab frequency and optimized morning lab timing to improve sleep.
Citation: Tapaskar N et al. Evaluation of the order SMARTT: An initiative to reduce phlebotomy and improve sleep-friendly labs on general medicine services. J Hosp Med. 2020;15:479-82.
Dr. Lockwood is a hospitalist and chief of quality, performance, and patient safety at the Lexington (Ky.) VA Health Care System.
Background: Daily labs are often unnecessary on clinically stable inpatients. Additionally, daily labs are frequently drawn very early in the morning, resulting in sleep disruptions. No prior studies have attempted an EHR-based intervention to simultaneously improve both frequency and timing of labs.
Study design: Quality improvement project.
Setting: Resident and hospitalist services at a single academic medical center.
Synopsis: After surveying providers about lab-ordering preferences, an EHR shortcut and visual reminder were built to facilitate labs being ordered every 48 hours at 6 a.m. (rather than daily at 4 a.m.). Results included 26.3% fewer routine lab draws per patient-day per week, and a significant increase in sleep-friendly lab order utilization per encounter per week on both resident services (intercept, 1.03; standard error, 0.29; P < .001) and hospitalist services (intercept, 1.17; SE, .50; P = .02).
Bottom line: An intervention consisting of physician education and an EHR tool reduced daily lab frequency and optimized morning lab timing to improve sleep.
Citation: Tapaskar N et al. Evaluation of the order SMARTT: An initiative to reduce phlebotomy and improve sleep-friendly labs on general medicine services. J Hosp Med. 2020;15:479-82.
Dr. Lockwood is a hospitalist and chief of quality, performance, and patient safety at the Lexington (Ky.) VA Health Care System.
Background: Daily labs are often unnecessary on clinically stable inpatients. Additionally, daily labs are frequently drawn very early in the morning, resulting in sleep disruptions. No prior studies have attempted an EHR-based intervention to simultaneously improve both frequency and timing of labs.
Study design: Quality improvement project.
Setting: Resident and hospitalist services at a single academic medical center.
Synopsis: After surveying providers about lab-ordering preferences, an EHR shortcut and visual reminder were built to facilitate labs being ordered every 48 hours at 6 a.m. (rather than daily at 4 a.m.). Results included 26.3% fewer routine lab draws per patient-day per week, and a significant increase in sleep-friendly lab order utilization per encounter per week on both resident services (intercept, 1.03; standard error, 0.29; P < .001) and hospitalist services (intercept, 1.17; SE, .50; P = .02).
Bottom line: An intervention consisting of physician education and an EHR tool reduced daily lab frequency and optimized morning lab timing to improve sleep.
Citation: Tapaskar N et al. Evaluation of the order SMARTT: An initiative to reduce phlebotomy and improve sleep-friendly labs on general medicine services. J Hosp Med. 2020;15:479-82.
Dr. Lockwood is a hospitalist and chief of quality, performance, and patient safety at the Lexington (Ky.) VA Health Care System.
AGA Clinical Practice Update: Expert review on GI perforations
A clinical practice update expert review from the American Gastroenterological Association gives advice on management of endoscopic perforations in the gastrointestinal tract, including esophageal, gastric, duodenal and periampullary, and colon perforation.
There are various techniques for dealing with perforations, including through-the-scope clips (TTSCs), over-the-scope clips (OTSCs), self-expanding metal stents (SEMS), and endoscopic suturing. Newer methods include biological glue and esophageal vacuum therapy. These techniques have been the subject of various retrospective analyses, but few prospective studies have examined their safety and efficacy.
In the expert review, published in Clinical Gastroenterology and Hepatology, authors led by Jeffrey H. Lee, MD, MPH, AGAF, of the department of gastroenterology at the University of Texas MD Anderson Cancer Center, Houston, emphasized that gastroenterologists should have a perforation protocol in place and practice procedures that will be used to address perforations. Endoscopists should also recognize their own limits and know when a patient should be sent to experienced, high-volume centers for further care.
In the event of a perforation, the entire team should be notified immediately, and carbon dioxide insufflation should be used at a low flow setting. The endoscopist should clean up luminal material to reduce the chance of peritoneal contamination, and then treat with an antibiotic regimen that counters gram-negative and anaerobic bacteria.
Esophageal perforation
Esophageal perforations most commonly occur during dilation of strictures, endoscopic mucosal resection (EMR), and endoscopic submucosal dissection (ESD). Perforations of the mucosal flap may happen during so-called third-space endoscopy techniques like peroral endoscopic myotomy (POEM). Small perforations can be readily addressed with TTSCs. Larger perforations call for some combination of TTSCs, endoscopic suturing, fibrin glue injection, or esophageal stenting, though the latter is discouraged because of the potential for erosion.
A more concerning complication of POEM is delayed barrier failure, which can cause leaks, mediastinitis, or peritonitis. These complications have been estimated to occur in 0.2%-1.1% of cases.
In the event of an esophageal perforation, the area should be kept clean by suctioning, or by altering patient position if required. Perforations 1-2 cm in size can be closed using OTSCs. Excessive bleeding or larger tears can be addressed using a fully covered SEMS.
Leaks that occur in the ensuing days after the procedure should be closed using TTSCs, OTSCs, or endosuturing, followed by putting in a fully covered stent. Esophageal fistula should be addressed with a fully covered stent with a tight fit.
Endoscopic vacuum therapy is a newer technique to address large or persistent esophageal perforations. A review found it had a 96% success rate for esophageal perforations.
Gastric perforations
Gastric perforations often result from peptic ulcer disease or ingestion of something caustic, and it is a high risk during EMR and ESD procedures (0.4%-0.7% intraprocedural risk). The proximal gastric wall isn’t thick as in the gastric antrum, so proximal endoscopic resections require extra care. Lengthy procedures should be done under anesthesia. Ongoing gaseous insufflation during a perforation may worsen the problem because of heightened intraperitoneal pressure. OTSCs may be a better choice than TTSCs for 1-3 cm perforations, while endoloop/TTSC can be used for larger ones.
Duodenal and periampullary perforations
Duodenal and periampullary perforations occur during duodenal stricture dilation, EMR, endoscopic submucosal dissection, endoscopic ultrasound, and endoscopic retrograde cholangiopancreatography (ECRP). The thin duodenal wall makes it more susceptible to perforation than the esophagus, stomach, or colon.
Closing a duodenum perforation can be difficult. Type 1 perforations typically show sudden bleeding and lumen deflation, and often require surgical intervention. Some recent reports have suggested success with TTSCs, OTSCs, band ligation, and endoloops. Type 2 perforations are less obvious, and the endoscopist must examine the gas pattern on fluoroscopic beneath the liver or in the area of the right kidney. Retroperitoneal air following ERCP, if asymptomatic, doesn’t necessarily require intervention.
The challenges presented by the duodenum mean that, for large duodenal polyps, EMR should only be done by experienced endoscopists who are skilled at mucosal closure, and only experts should attempt ESD. Proteolytic enzymes from the pancreas can also pool in the duodenum, which can degrade muscle tissue and lead to delayed perforations. TTSC, OTSC, endosuturing, polymer gels or sheets, and TTSC combined with endoloop cinching have been used to close resection-associated perforations.
Colon perforation
Colon perforation may be caused by diverticulitis, inflammatory bowel disease, or occasionally colonic obstruction. Iatrogenic causes are more common and include endoscopic resection, hot forceps biopsy, dilation of stricture resulting from radiation or Crohn’s disease, colonic stenting, and advancement of colonoscope across angulations or into diverticula without straightening the endoscope
Large perforations are usually immediately noticeable and should be treated surgically, as should hemodynamic instability or delayed perforations with peritoneal signs.
Endoscopic closure should be attempted when the perforation site is clean, and lower rectal perforations can generally be repaired with TTSC, OTSC, or endoscopic suturing. In the cecum, or in a torturous or unclean colon, it may be difficult or dangerous to remove the colonoscope and insert an OTSC, and endoscopic suturing may not be possible, making TTSC the only procedure available for right colon perforations. The X-Tack Endoscopic HeliX Tacking System is a recently introduced, through-the-scope technology that places suture-tethered tacks into tissue surrounding the perforation and cinches it together. The system in principle can close large or irregular colonic and small bowel perforations using gastroscopes and colonoscopes, but no human studies have yet been published.
Conclusion
This update was a collaborative effort by four endoscopists who felt that it was timely to review the issue of perforations since they can be serious and challenging to manage. The evolution of endoscopic techniques over the last few years, however, has made the closure of spontaneous and iatrogenic perforations much less fear provoking, and they wished to summarize the approaches to a variety of such situations in order to guide practitioners who may encounter them.
“Although perforation is a serious event, with novel endoscopic techniques and tools, the endoscopist should no longer be paralyzed when it occurs,” the authors concluded.
Some authors reported relationships, such as consulting for or royalties from, device companies such as Medtronic and Boston Scientific. The remaining authors disclosed no conflicts.
This article was updated Oct. 25, 2021.
A clinical practice update expert review from the American Gastroenterological Association gives advice on management of endoscopic perforations in the gastrointestinal tract, including esophageal, gastric, duodenal and periampullary, and colon perforation.
There are various techniques for dealing with perforations, including through-the-scope clips (TTSCs), over-the-scope clips (OTSCs), self-expanding metal stents (SEMS), and endoscopic suturing. Newer methods include biological glue and esophageal vacuum therapy. These techniques have been the subject of various retrospective analyses, but few prospective studies have examined their safety and efficacy.
In the expert review, published in Clinical Gastroenterology and Hepatology, authors led by Jeffrey H. Lee, MD, MPH, AGAF, of the department of gastroenterology at the University of Texas MD Anderson Cancer Center, Houston, emphasized that gastroenterologists should have a perforation protocol in place and practice procedures that will be used to address perforations. Endoscopists should also recognize their own limits and know when a patient should be sent to experienced, high-volume centers for further care.
In the event of a perforation, the entire team should be notified immediately, and carbon dioxide insufflation should be used at a low flow setting. The endoscopist should clean up luminal material to reduce the chance of peritoneal contamination, and then treat with an antibiotic regimen that counters gram-negative and anaerobic bacteria.
Esophageal perforation
Esophageal perforations most commonly occur during dilation of strictures, endoscopic mucosal resection (EMR), and endoscopic submucosal dissection (ESD). Perforations of the mucosal flap may happen during so-called third-space endoscopy techniques like peroral endoscopic myotomy (POEM). Small perforations can be readily addressed with TTSCs. Larger perforations call for some combination of TTSCs, endoscopic suturing, fibrin glue injection, or esophageal stenting, though the latter is discouraged because of the potential for erosion.
A more concerning complication of POEM is delayed barrier failure, which can cause leaks, mediastinitis, or peritonitis. These complications have been estimated to occur in 0.2%-1.1% of cases.
In the event of an esophageal perforation, the area should be kept clean by suctioning, or by altering patient position if required. Perforations 1-2 cm in size can be closed using OTSCs. Excessive bleeding or larger tears can be addressed using a fully covered SEMS.
Leaks that occur in the ensuing days after the procedure should be closed using TTSCs, OTSCs, or endosuturing, followed by putting in a fully covered stent. Esophageal fistula should be addressed with a fully covered stent with a tight fit.
Endoscopic vacuum therapy is a newer technique to address large or persistent esophageal perforations. A review found it had a 96% success rate for esophageal perforations.
Gastric perforations
Gastric perforations often result from peptic ulcer disease or ingestion of something caustic, and it is a high risk during EMR and ESD procedures (0.4%-0.7% intraprocedural risk). The proximal gastric wall isn’t thick as in the gastric antrum, so proximal endoscopic resections require extra care. Lengthy procedures should be done under anesthesia. Ongoing gaseous insufflation during a perforation may worsen the problem because of heightened intraperitoneal pressure. OTSCs may be a better choice than TTSCs for 1-3 cm perforations, while endoloop/TTSC can be used for larger ones.
Duodenal and periampullary perforations
Duodenal and periampullary perforations occur during duodenal stricture dilation, EMR, endoscopic submucosal dissection, endoscopic ultrasound, and endoscopic retrograde cholangiopancreatography (ECRP). The thin duodenal wall makes it more susceptible to perforation than the esophagus, stomach, or colon.
Closing a duodenum perforation can be difficult. Type 1 perforations typically show sudden bleeding and lumen deflation, and often require surgical intervention. Some recent reports have suggested success with TTSCs, OTSCs, band ligation, and endoloops. Type 2 perforations are less obvious, and the endoscopist must examine the gas pattern on fluoroscopic beneath the liver or in the area of the right kidney. Retroperitoneal air following ERCP, if asymptomatic, doesn’t necessarily require intervention.
The challenges presented by the duodenum mean that, for large duodenal polyps, EMR should only be done by experienced endoscopists who are skilled at mucosal closure, and only experts should attempt ESD. Proteolytic enzymes from the pancreas can also pool in the duodenum, which can degrade muscle tissue and lead to delayed perforations. TTSC, OTSC, endosuturing, polymer gels or sheets, and TTSC combined with endoloop cinching have been used to close resection-associated perforations.
Colon perforation
Colon perforation may be caused by diverticulitis, inflammatory bowel disease, or occasionally colonic obstruction. Iatrogenic causes are more common and include endoscopic resection, hot forceps biopsy, dilation of stricture resulting from radiation or Crohn’s disease, colonic stenting, and advancement of colonoscope across angulations or into diverticula without straightening the endoscope
Large perforations are usually immediately noticeable and should be treated surgically, as should hemodynamic instability or delayed perforations with peritoneal signs.
Endoscopic closure should be attempted when the perforation site is clean, and lower rectal perforations can generally be repaired with TTSC, OTSC, or endoscopic suturing. In the cecum, or in a torturous or unclean colon, it may be difficult or dangerous to remove the colonoscope and insert an OTSC, and endoscopic suturing may not be possible, making TTSC the only procedure available for right colon perforations. The X-Tack Endoscopic HeliX Tacking System is a recently introduced, through-the-scope technology that places suture-tethered tacks into tissue surrounding the perforation and cinches it together. The system in principle can close large or irregular colonic and small bowel perforations using gastroscopes and colonoscopes, but no human studies have yet been published.
Conclusion
This update was a collaborative effort by four endoscopists who felt that it was timely to review the issue of perforations since they can be serious and challenging to manage. The evolution of endoscopic techniques over the last few years, however, has made the closure of spontaneous and iatrogenic perforations much less fear provoking, and they wished to summarize the approaches to a variety of such situations in order to guide practitioners who may encounter them.
“Although perforation is a serious event, with novel endoscopic techniques and tools, the endoscopist should no longer be paralyzed when it occurs,” the authors concluded.
Some authors reported relationships, such as consulting for or royalties from, device companies such as Medtronic and Boston Scientific. The remaining authors disclosed no conflicts.
This article was updated Oct. 25, 2021.
A clinical practice update expert review from the American Gastroenterological Association gives advice on management of endoscopic perforations in the gastrointestinal tract, including esophageal, gastric, duodenal and periampullary, and colon perforation.
There are various techniques for dealing with perforations, including through-the-scope clips (TTSCs), over-the-scope clips (OTSCs), self-expanding metal stents (SEMS), and endoscopic suturing. Newer methods include biological glue and esophageal vacuum therapy. These techniques have been the subject of various retrospective analyses, but few prospective studies have examined their safety and efficacy.
In the expert review, published in Clinical Gastroenterology and Hepatology, authors led by Jeffrey H. Lee, MD, MPH, AGAF, of the department of gastroenterology at the University of Texas MD Anderson Cancer Center, Houston, emphasized that gastroenterologists should have a perforation protocol in place and practice procedures that will be used to address perforations. Endoscopists should also recognize their own limits and know when a patient should be sent to experienced, high-volume centers for further care.
In the event of a perforation, the entire team should be notified immediately, and carbon dioxide insufflation should be used at a low flow setting. The endoscopist should clean up luminal material to reduce the chance of peritoneal contamination, and then treat with an antibiotic regimen that counters gram-negative and anaerobic bacteria.
Esophageal perforation
Esophageal perforations most commonly occur during dilation of strictures, endoscopic mucosal resection (EMR), and endoscopic submucosal dissection (ESD). Perforations of the mucosal flap may happen during so-called third-space endoscopy techniques like peroral endoscopic myotomy (POEM). Small perforations can be readily addressed with TTSCs. Larger perforations call for some combination of TTSCs, endoscopic suturing, fibrin glue injection, or esophageal stenting, though the latter is discouraged because of the potential for erosion.
A more concerning complication of POEM is delayed barrier failure, which can cause leaks, mediastinitis, or peritonitis. These complications have been estimated to occur in 0.2%-1.1% of cases.
In the event of an esophageal perforation, the area should be kept clean by suctioning, or by altering patient position if required. Perforations 1-2 cm in size can be closed using OTSCs. Excessive bleeding or larger tears can be addressed using a fully covered SEMS.
Leaks that occur in the ensuing days after the procedure should be closed using TTSCs, OTSCs, or endosuturing, followed by putting in a fully covered stent. Esophageal fistula should be addressed with a fully covered stent with a tight fit.
Endoscopic vacuum therapy is a newer technique to address large or persistent esophageal perforations. A review found it had a 96% success rate for esophageal perforations.
Gastric perforations
Gastric perforations often result from peptic ulcer disease or ingestion of something caustic, and it is a high risk during EMR and ESD procedures (0.4%-0.7% intraprocedural risk). The proximal gastric wall isn’t thick as in the gastric antrum, so proximal endoscopic resections require extra care. Lengthy procedures should be done under anesthesia. Ongoing gaseous insufflation during a perforation may worsen the problem because of heightened intraperitoneal pressure. OTSCs may be a better choice than TTSCs for 1-3 cm perforations, while endoloop/TTSC can be used for larger ones.
Duodenal and periampullary perforations
Duodenal and periampullary perforations occur during duodenal stricture dilation, EMR, endoscopic submucosal dissection, endoscopic ultrasound, and endoscopic retrograde cholangiopancreatography (ECRP). The thin duodenal wall makes it more susceptible to perforation than the esophagus, stomach, or colon.
Closing a duodenum perforation can be difficult. Type 1 perforations typically show sudden bleeding and lumen deflation, and often require surgical intervention. Some recent reports have suggested success with TTSCs, OTSCs, band ligation, and endoloops. Type 2 perforations are less obvious, and the endoscopist must examine the gas pattern on fluoroscopic beneath the liver or in the area of the right kidney. Retroperitoneal air following ERCP, if asymptomatic, doesn’t necessarily require intervention.
The challenges presented by the duodenum mean that, for large duodenal polyps, EMR should only be done by experienced endoscopists who are skilled at mucosal closure, and only experts should attempt ESD. Proteolytic enzymes from the pancreas can also pool in the duodenum, which can degrade muscle tissue and lead to delayed perforations. TTSC, OTSC, endosuturing, polymer gels or sheets, and TTSC combined with endoloop cinching have been used to close resection-associated perforations.
Colon perforation
Colon perforation may be caused by diverticulitis, inflammatory bowel disease, or occasionally colonic obstruction. Iatrogenic causes are more common and include endoscopic resection, hot forceps biopsy, dilation of stricture resulting from radiation or Crohn’s disease, colonic stenting, and advancement of colonoscope across angulations or into diverticula without straightening the endoscope
Large perforations are usually immediately noticeable and should be treated surgically, as should hemodynamic instability or delayed perforations with peritoneal signs.
Endoscopic closure should be attempted when the perforation site is clean, and lower rectal perforations can generally be repaired with TTSC, OTSC, or endoscopic suturing. In the cecum, or in a torturous or unclean colon, it may be difficult or dangerous to remove the colonoscope and insert an OTSC, and endoscopic suturing may not be possible, making TTSC the only procedure available for right colon perforations. The X-Tack Endoscopic HeliX Tacking System is a recently introduced, through-the-scope technology that places suture-tethered tacks into tissue surrounding the perforation and cinches it together. The system in principle can close large or irregular colonic and small bowel perforations using gastroscopes and colonoscopes, but no human studies have yet been published.
Conclusion
This update was a collaborative effort by four endoscopists who felt that it was timely to review the issue of perforations since they can be serious and challenging to manage. The evolution of endoscopic techniques over the last few years, however, has made the closure of spontaneous and iatrogenic perforations much less fear provoking, and they wished to summarize the approaches to a variety of such situations in order to guide practitioners who may encounter them.
“Although perforation is a serious event, with novel endoscopic techniques and tools, the endoscopist should no longer be paralyzed when it occurs,” the authors concluded.
Some authors reported relationships, such as consulting for or royalties from, device companies such as Medtronic and Boston Scientific. The remaining authors disclosed no conflicts.
This article was updated Oct. 25, 2021.
FROM THE CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Stay tuned for CSI: Olive oil
Cracking down on food fraud
How do you know the olive oil in your pantry is from Greece? Or that the avocados on your toast are from Mexico? The label, right? Well, maybe not. False claims of origin are a huge problem in the food industry, costing over $30 billion in economic damage annually.
Fear not, citizens, because botanists are on the job, and they’ve found a cheaper and more efficient way to expose that non-Greek olive oil.
How? Florian Cueni, PhD, of the University of Basel, Switzerland, and associates developed a new model to simulate oxygen isotope ratios in plants from a specific region, based on the temperature, precipitation, growing season information, and humidity data. Previously, botanists had to collect reference data from the claimed origin country and from other regions to validate where the product actually came from.
“With minor adjustments to the parameters, our model can be used to determine all plant products,” said senior investigator Ansgar Kahmen. This can open up the door for even more plant forensics, including drug confiscations and illegal timber logging, with information that will hold up in court.
Why pay Greek-olive prices for olives from California?
Fear leads to anger, anger leads to unhelpful online reviews
And reading angry online reviews leads to hate and suffering. We may have co-opted Master Yoda’s wise words ever so slightly, but anyone who’s done any shopping online (so everyone) knows that the review section of any product can be downright villainous. Do these reviews affect what we buy?
The angry online product review was the subject of a recent study published in MIS Quarterly. In a series of experiments, participants were shown a series of realistic online reviews with varying amounts of anger but with similar amounts of information. After reading the reviews, participants rated helpfulness, their personal opinion of the product/retailer, and whether or not they would buy the product.
Participants overwhelmingly rated calmly written reviews as more helpful than angrily written ones. One would expect, then, that those unhelpful angry reviews would have little effect on the participant’s view or willingness to buy a product, but the study investigators found the opposite. Reading angry reviews made the participants more likely to reject the product, even though they didn’t think the angry review was useful. And when you think about it, it does make sense. Anger means drama, and we can’t resist a juicy bit of drama.
So while we should all aspire to be Yoda and rise above anger and hatred, in reality we seem to be channeling Emperor Palpatine. We let the hate flow through us, and in our anger, we ignore perfectly good products. On the plus side, now we can shoot lightning out of our hands, so that’s pretty cool.
Health care is heading to the hall of fame
We couldn’t be happier here at LOTME because it’s that time of year again.
No, we’re not talking about Healthcare Security and Safety Week or National Metric Week, although those are both kind of important. Hmm, maybe we should talk about health care security or the metric system. After all, in this country, medicine is one of the metric system’s biggest customers. And who doesn’t love picograms? They’re the unit-of-measurement equivalent of a koala.
So we’re doing the metric system, then? Nah.
We’re excited because the 2022 inductees to the National Inventors Hall of Fame were just announced, and, as usual, the world of health care is well represented.
First up is the surprisingly relevant (thanks to the party guest that won’t leave, SARS-CoV-2) pair of Katalin Karikó, PhD, and Drew Weissman, MD, who worked together in the early 2000s to modify mRNA “so it could avoid immediate immune detection, remain active longer and efficiently instruct cells to create antigens to protect against severe disease.” Their discoveries eventually led to the use of modified mRNA in the COVID-19 vaccines.
The second, albeit posthumous, physician-inductee is Patricia Bath, MD, who was the first Black female physician to receive a U.S. patent for a medical invention. The laserphaco device and technique to remove cataracts “performed all steps of cataract removal: making the incision, destroying the lens, and vacuuming out the fractured pieces.”
Two other inductees have somewhat tenuous connections to medical care. Lonnie Johnson invented the Super Soaker, a powerful squirt gun that has been criticized by psychologists for encouraging violence, and Carl Benz invented the automobile, which sort of means he invented the ambulance, so there you go.
The induction ceremony takes place on May 5, 2022, in Washington, DC. If you’re attending the black-tie dinner at The Anthem, let us know and we’ll split an Uber. It’s our only night to be fancy.
Cracking down on food fraud
How do you know the olive oil in your pantry is from Greece? Or that the avocados on your toast are from Mexico? The label, right? Well, maybe not. False claims of origin are a huge problem in the food industry, costing over $30 billion in economic damage annually.
Fear not, citizens, because botanists are on the job, and they’ve found a cheaper and more efficient way to expose that non-Greek olive oil.
How? Florian Cueni, PhD, of the University of Basel, Switzerland, and associates developed a new model to simulate oxygen isotope ratios in plants from a specific region, based on the temperature, precipitation, growing season information, and humidity data. Previously, botanists had to collect reference data from the claimed origin country and from other regions to validate where the product actually came from.
“With minor adjustments to the parameters, our model can be used to determine all plant products,” said senior investigator Ansgar Kahmen. This can open up the door for even more plant forensics, including drug confiscations and illegal timber logging, with information that will hold up in court.
Why pay Greek-olive prices for olives from California?
Fear leads to anger, anger leads to unhelpful online reviews
And reading angry online reviews leads to hate and suffering. We may have co-opted Master Yoda’s wise words ever so slightly, but anyone who’s done any shopping online (so everyone) knows that the review section of any product can be downright villainous. Do these reviews affect what we buy?
The angry online product review was the subject of a recent study published in MIS Quarterly. In a series of experiments, participants were shown a series of realistic online reviews with varying amounts of anger but with similar amounts of information. After reading the reviews, participants rated helpfulness, their personal opinion of the product/retailer, and whether or not they would buy the product.
Participants overwhelmingly rated calmly written reviews as more helpful than angrily written ones. One would expect, then, that those unhelpful angry reviews would have little effect on the participant’s view or willingness to buy a product, but the study investigators found the opposite. Reading angry reviews made the participants more likely to reject the product, even though they didn’t think the angry review was useful. And when you think about it, it does make sense. Anger means drama, and we can’t resist a juicy bit of drama.
So while we should all aspire to be Yoda and rise above anger and hatred, in reality we seem to be channeling Emperor Palpatine. We let the hate flow through us, and in our anger, we ignore perfectly good products. On the plus side, now we can shoot lightning out of our hands, so that’s pretty cool.
Health care is heading to the hall of fame
We couldn’t be happier here at LOTME because it’s that time of year again.
No, we’re not talking about Healthcare Security and Safety Week or National Metric Week, although those are both kind of important. Hmm, maybe we should talk about health care security or the metric system. After all, in this country, medicine is one of the metric system’s biggest customers. And who doesn’t love picograms? They’re the unit-of-measurement equivalent of a koala.
So we’re doing the metric system, then? Nah.
We’re excited because the 2022 inductees to the National Inventors Hall of Fame were just announced, and, as usual, the world of health care is well represented.
First up is the surprisingly relevant (thanks to the party guest that won’t leave, SARS-CoV-2) pair of Katalin Karikó, PhD, and Drew Weissman, MD, who worked together in the early 2000s to modify mRNA “so it could avoid immediate immune detection, remain active longer and efficiently instruct cells to create antigens to protect against severe disease.” Their discoveries eventually led to the use of modified mRNA in the COVID-19 vaccines.
The second, albeit posthumous, physician-inductee is Patricia Bath, MD, who was the first Black female physician to receive a U.S. patent for a medical invention. The laserphaco device and technique to remove cataracts “performed all steps of cataract removal: making the incision, destroying the lens, and vacuuming out the fractured pieces.”
Two other inductees have somewhat tenuous connections to medical care. Lonnie Johnson invented the Super Soaker, a powerful squirt gun that has been criticized by psychologists for encouraging violence, and Carl Benz invented the automobile, which sort of means he invented the ambulance, so there you go.
The induction ceremony takes place on May 5, 2022, in Washington, DC. If you’re attending the black-tie dinner at The Anthem, let us know and we’ll split an Uber. It’s our only night to be fancy.
Cracking down on food fraud
How do you know the olive oil in your pantry is from Greece? Or that the avocados on your toast are from Mexico? The label, right? Well, maybe not. False claims of origin are a huge problem in the food industry, costing over $30 billion in economic damage annually.
Fear not, citizens, because botanists are on the job, and they’ve found a cheaper and more efficient way to expose that non-Greek olive oil.
How? Florian Cueni, PhD, of the University of Basel, Switzerland, and associates developed a new model to simulate oxygen isotope ratios in plants from a specific region, based on the temperature, precipitation, growing season information, and humidity data. Previously, botanists had to collect reference data from the claimed origin country and from other regions to validate where the product actually came from.
“With minor adjustments to the parameters, our model can be used to determine all plant products,” said senior investigator Ansgar Kahmen. This can open up the door for even more plant forensics, including drug confiscations and illegal timber logging, with information that will hold up in court.
Why pay Greek-olive prices for olives from California?
Fear leads to anger, anger leads to unhelpful online reviews
And reading angry online reviews leads to hate and suffering. We may have co-opted Master Yoda’s wise words ever so slightly, but anyone who’s done any shopping online (so everyone) knows that the review section of any product can be downright villainous. Do these reviews affect what we buy?
The angry online product review was the subject of a recent study published in MIS Quarterly. In a series of experiments, participants were shown a series of realistic online reviews with varying amounts of anger but with similar amounts of information. After reading the reviews, participants rated helpfulness, their personal opinion of the product/retailer, and whether or not they would buy the product.
Participants overwhelmingly rated calmly written reviews as more helpful than angrily written ones. One would expect, then, that those unhelpful angry reviews would have little effect on the participant’s view or willingness to buy a product, but the study investigators found the opposite. Reading angry reviews made the participants more likely to reject the product, even though they didn’t think the angry review was useful. And when you think about it, it does make sense. Anger means drama, and we can’t resist a juicy bit of drama.
So while we should all aspire to be Yoda and rise above anger and hatred, in reality we seem to be channeling Emperor Palpatine. We let the hate flow through us, and in our anger, we ignore perfectly good products. On the plus side, now we can shoot lightning out of our hands, so that’s pretty cool.
Health care is heading to the hall of fame
We couldn’t be happier here at LOTME because it’s that time of year again.
No, we’re not talking about Healthcare Security and Safety Week or National Metric Week, although those are both kind of important. Hmm, maybe we should talk about health care security or the metric system. After all, in this country, medicine is one of the metric system’s biggest customers. And who doesn’t love picograms? They’re the unit-of-measurement equivalent of a koala.
So we’re doing the metric system, then? Nah.
We’re excited because the 2022 inductees to the National Inventors Hall of Fame were just announced, and, as usual, the world of health care is well represented.
First up is the surprisingly relevant (thanks to the party guest that won’t leave, SARS-CoV-2) pair of Katalin Karikó, PhD, and Drew Weissman, MD, who worked together in the early 2000s to modify mRNA “so it could avoid immediate immune detection, remain active longer and efficiently instruct cells to create antigens to protect against severe disease.” Their discoveries eventually led to the use of modified mRNA in the COVID-19 vaccines.
The second, albeit posthumous, physician-inductee is Patricia Bath, MD, who was the first Black female physician to receive a U.S. patent for a medical invention. The laserphaco device and technique to remove cataracts “performed all steps of cataract removal: making the incision, destroying the lens, and vacuuming out the fractured pieces.”
Two other inductees have somewhat tenuous connections to medical care. Lonnie Johnson invented the Super Soaker, a powerful squirt gun that has been criticized by psychologists for encouraging violence, and Carl Benz invented the automobile, which sort of means he invented the ambulance, so there you go.
The induction ceremony takes place on May 5, 2022, in Washington, DC. If you’re attending the black-tie dinner at The Anthem, let us know and we’ll split an Uber. It’s our only night to be fancy.
Fecal microbiota transplants may improve resistance to melanoma immunotherapy
In the fall of 2020, Hassane M. Zarour, MD, and colleagues began to pore over raw data from their
Preclinical mouse studies have demonstrated that the gut microbiota could influence the response of tumors to anti–PD-1 immunotherapy, but FMT had not been previously evaluated in human patients with malignant melanoma whose disease persisted or progressed after medical therapy. Only 30%-40% of melanoma patients respond to anti–PD-1 immunotherapy, so the researchers’ sense of anticipation was palpable. “It’s a high-risk, high-reward study, so you never know,” Dr. Zarour, a dermatologist and immunologist who is coleader of the melanoma program at the University of Pittsburgh Medical Center’s Hillman Cancer Center, said in an interview.
For the study, which was funded by the National Institutes of Health and published in Science, Dr. Zarour and a team of colleagues, including Diwakar Davar, MD, a medical oncologist/hematologist at UPMC and Giorgio Trinchieri, MD, head of the cancer immunology section at the National Cancer Institute, enrolled 16 patients with advanced melanoma whose disease had persisted or progressed with anti-PD-1 drugs; donors were 7 patients with advanced melanoma who had responded to pembrolizumab, 4 with a complete response and 3 with a partial response, with a median progression-free survival of 56 months.
After donors and patients underwent serial stool sampling and studies to stamp out the potential for transmitting infectious agents, the researchers administered the donor-derived FMT to patients via colonoscopy every 14 days for 3 weeks, followed by pembrolizumab. To their delight, 6 of the 15 evaluable recipients responded to treatment, with a reduction in tumor or long-term disease stabilization. Moreover, responders also showed increased abundance of taxa that were previously associated with response to immunotherapy, increased activation of CD8+ T cells, and decreased frequency of interleukin-8–expressing myeloid cells.
“This opens new doors for the future,” Dr. Zarour said. “It’s very encouraging, but I don’t want to overstate the data. It’s a small, nonrandomized trial, but one has to keep in mind that people were skeptical about this work; they didn’t think FMT would work. Now we see many people coming into the field to investigate the role of the microbiome as a therapeutic tool, which is great.”
Teri Greiling, MD, characterized the finding as a key development in understanding the microbiome’s potential to influence the course of melanoma and other diseases. “What’s emerging over the last decade of research is that our immune system has a close, back-and-forth relationship with our microbiota,” said Dr. Greiling, associate professor of dermatology at Oregon Health & Science University, Portland. “From day 1 of birth, we’re colonized by microbes that train our immune system how to function. In response, your immune system keeps those microbes in check and shapes which ones are allowed to colonize, and which ones are a target for attack. Thus, inflammatory responses are generated. Similarly, the goal of immunotherapy is to activate the immune system to fight cancer. This study shows that the immune system continues to need the colonizing microbes in our body to function optimally.”
Immunotherapy with checkpoint inhibitors was not an option for malignant melanoma patients until 2011, she noted, so the potential for FMT to further improve outcomes is welcome news for patients and their families. “We went from a less than 5% chance of survival with metastatic melanoma to now, with the right combination of checkpoint inhibitors, we’re up over 50%, which is amazing in a decade,” Dr. Greiling said. “Still, we’re losing half of our patients. If [FMT provides] a 30% improvement over that, that would be great, but it’s hard to extrapolate from such small numbers.”
Positive results in an Israeli study
Results from a similar, smaller phase 1 trial of 2 FMT donors and 10 recipients with metastatic melanoma who had progressed on anti-PD-1 therapy, from the Ella Lemelbaum Institute for Immuno-Oncology at Sheba Medical Center in Tel HaShomer, Israel, yielded similar results. The FMT protocol in this study included colonoscopy and oral stool capsules, followed by the reintroduction of anti–PD-1 therapy with nivolumab. The two FMT donors had previously been treated with anti–PD-1 monotherapy for metastatic melanoma and had achieved a clinical response for at least 1 year. Of the 10 FMT recipients, 1 had a complete response and 2 had a partial response.
“We expected changes in the immune system but did not expect that 3 out of the 10 patients in our study would be turned from nonresponders to responders,” the study’s lead author, Erez N. Baruch, MD, PhD, told this news organization. “Since this was a first-in-human study, we were aiming to assess safety and not clinical responses. [We found] that microbiota modulation can change the immune infiltration within melanoma tumors and by this affect response to immunotherapy.”
Dr. Baruch, an internal medicine resident in the physician-scientist track program at the University of Texas, Houston, said that the findings create a potential new therapeutic paradigm, or a new “playing ground” for drug development that can support existing immunotherapies. “It is important for dermatologists to understand that disruptions of the gut microbiota, mainly by antibiotics, may be harmful to melanoma patients,” he said. “Antibiotics in cancer patients should be used judiciously but of course should not be avoided when there’s an indication.”
As for next steps, Dr. Zarour and colleagues are recruiting more patients to boost their sample size and conducting sequential analysis of the microbiome of study participants “to better determine what the good and bad bugs are,” he said. “There are so many variables, including diet and geography. We need more data.” The hope is to develop a “microbiome signature” to identify patients likely to respond to FMT, and maybe one day, a probiotic capsule that patients take to optimize their response to immunotherapy.
“We don’t want to say that the microbiome is responsible for everything, but it’s responsible for some of the response and some of the resistance to treatment,” Dr. Zarour said. “So, we want to identify what candidate nonresponders are more likely to respond to FMT and be able to stick the right stool in the donor. This goes to better education of the microbiome signature. We are working hard on that.”
Dr. Baruch added that performing FMT for melanoma patients requires tight collaborations between oncologists, dermatologists, GI, and infectious disease experts. “These usually can be done in the setting of large cancer centers and will probably not be available in any hospital,” he said. “This is why understanding the mechanisms and developing an FMT-like drug is important. We are focusing on studying the mechanisms behind the clinical effect in order to develop a drug with an FMT-like effect without the safety and logistic issues related to FMTs.”
Tamia A. Harris-Tryon, MD, PhD, whose lab at the University of Texas Southwestern Medical Center at Dallas is studying how diet and the microbiota impact skin immunity, underscored the importance of evaluating the characteristics of the diet of patients as trials of FMT in melanoma patients carry on. “We know that the diet impacts the repertoire of microbes that colonize the gut,” said Dr. Harris-Tryon, assistant professor in the department of dermatology at the medical center. “The diet of the recipient likely has an impact” on the success of donor FMT.
She also noted that other skin conditions have been linked to a disrupted gut microbiome, such as psoriasis. “Given the safety of FMT in both of these studies, trials of FMT in psoriasis and other systemic skin conditions should be considered,” she said.
According to Dr. Zarour, mounting data from separate studies show that some gut microbiota play a role in adverse events experienced by melanoma patients on immunotherapy. “That is very important, especially with combination therapy,” he said. “There are also microbes involved in resistance to treatment, so the idea would be to identify these microbes.”
Studies raise more questions
In the opinion of Dr. Greiling, results from these two studies raise more questions than they answer. “The big question ... is why and how does FMT work, and how can we make the response better?” she said. “Is there one particular gene product from one microbe that is the key magic ingredient, and we can harness this as a drug? More likely it’s a complex interplay between multiple bacterial species needed to direct the immune response. Is there a group of microbes that is the same from person to person, or is it more complex?”
Then there are pending regulatory concerns. “We know that FMT works for [Clostridioides] difficile colitis but it’s not officially [Food and Drug Administration] approved,” Dr. Greiling said. “The FDA is really struggling with how to approve or regulate using bacteria as a drug. Where is that crossover? That inhibits things moving forward, for good reason. You want to balance safety with live microbes.”
The UPMC clinical trial was supported by Merck. Dr. Zarour disclosed that he is supported by grants from the National Cancer Institute and the James W. and Frances G. McGlothlin Chair in Melanoma Immunotherapy Research at UPMC. The Israeli study was funded by the Ella Lemelbaum Institute for Immuno-Oncology. Dr. Baruch was supported by the Allen Berg Fund for Excellence in Immuno-Oncology Research. Dr. Greiling and Dr. Harris-Tryon reported having no relevant financial disclosures.
In the fall of 2020, Hassane M. Zarour, MD, and colleagues began to pore over raw data from their
Preclinical mouse studies have demonstrated that the gut microbiota could influence the response of tumors to anti–PD-1 immunotherapy, but FMT had not been previously evaluated in human patients with malignant melanoma whose disease persisted or progressed after medical therapy. Only 30%-40% of melanoma patients respond to anti–PD-1 immunotherapy, so the researchers’ sense of anticipation was palpable. “It’s a high-risk, high-reward study, so you never know,” Dr. Zarour, a dermatologist and immunologist who is coleader of the melanoma program at the University of Pittsburgh Medical Center’s Hillman Cancer Center, said in an interview.
For the study, which was funded by the National Institutes of Health and published in Science, Dr. Zarour and a team of colleagues, including Diwakar Davar, MD, a medical oncologist/hematologist at UPMC and Giorgio Trinchieri, MD, head of the cancer immunology section at the National Cancer Institute, enrolled 16 patients with advanced melanoma whose disease had persisted or progressed with anti-PD-1 drugs; donors were 7 patients with advanced melanoma who had responded to pembrolizumab, 4 with a complete response and 3 with a partial response, with a median progression-free survival of 56 months.
After donors and patients underwent serial stool sampling and studies to stamp out the potential for transmitting infectious agents, the researchers administered the donor-derived FMT to patients via colonoscopy every 14 days for 3 weeks, followed by pembrolizumab. To their delight, 6 of the 15 evaluable recipients responded to treatment, with a reduction in tumor or long-term disease stabilization. Moreover, responders also showed increased abundance of taxa that were previously associated with response to immunotherapy, increased activation of CD8+ T cells, and decreased frequency of interleukin-8–expressing myeloid cells.
“This opens new doors for the future,” Dr. Zarour said. “It’s very encouraging, but I don’t want to overstate the data. It’s a small, nonrandomized trial, but one has to keep in mind that people were skeptical about this work; they didn’t think FMT would work. Now we see many people coming into the field to investigate the role of the microbiome as a therapeutic tool, which is great.”
Teri Greiling, MD, characterized the finding as a key development in understanding the microbiome’s potential to influence the course of melanoma and other diseases. “What’s emerging over the last decade of research is that our immune system has a close, back-and-forth relationship with our microbiota,” said Dr. Greiling, associate professor of dermatology at Oregon Health & Science University, Portland. “From day 1 of birth, we’re colonized by microbes that train our immune system how to function. In response, your immune system keeps those microbes in check and shapes which ones are allowed to colonize, and which ones are a target for attack. Thus, inflammatory responses are generated. Similarly, the goal of immunotherapy is to activate the immune system to fight cancer. This study shows that the immune system continues to need the colonizing microbes in our body to function optimally.”
Immunotherapy with checkpoint inhibitors was not an option for malignant melanoma patients until 2011, she noted, so the potential for FMT to further improve outcomes is welcome news for patients and their families. “We went from a less than 5% chance of survival with metastatic melanoma to now, with the right combination of checkpoint inhibitors, we’re up over 50%, which is amazing in a decade,” Dr. Greiling said. “Still, we’re losing half of our patients. If [FMT provides] a 30% improvement over that, that would be great, but it’s hard to extrapolate from such small numbers.”
Positive results in an Israeli study
Results from a similar, smaller phase 1 trial of 2 FMT donors and 10 recipients with metastatic melanoma who had progressed on anti-PD-1 therapy, from the Ella Lemelbaum Institute for Immuno-Oncology at Sheba Medical Center in Tel HaShomer, Israel, yielded similar results. The FMT protocol in this study included colonoscopy and oral stool capsules, followed by the reintroduction of anti–PD-1 therapy with nivolumab. The two FMT donors had previously been treated with anti–PD-1 monotherapy for metastatic melanoma and had achieved a clinical response for at least 1 year. Of the 10 FMT recipients, 1 had a complete response and 2 had a partial response.
“We expected changes in the immune system but did not expect that 3 out of the 10 patients in our study would be turned from nonresponders to responders,” the study’s lead author, Erez N. Baruch, MD, PhD, told this news organization. “Since this was a first-in-human study, we were aiming to assess safety and not clinical responses. [We found] that microbiota modulation can change the immune infiltration within melanoma tumors and by this affect response to immunotherapy.”
Dr. Baruch, an internal medicine resident in the physician-scientist track program at the University of Texas, Houston, said that the findings create a potential new therapeutic paradigm, or a new “playing ground” for drug development that can support existing immunotherapies. “It is important for dermatologists to understand that disruptions of the gut microbiota, mainly by antibiotics, may be harmful to melanoma patients,” he said. “Antibiotics in cancer patients should be used judiciously but of course should not be avoided when there’s an indication.”
As for next steps, Dr. Zarour and colleagues are recruiting more patients to boost their sample size and conducting sequential analysis of the microbiome of study participants “to better determine what the good and bad bugs are,” he said. “There are so many variables, including diet and geography. We need more data.” The hope is to develop a “microbiome signature” to identify patients likely to respond to FMT, and maybe one day, a probiotic capsule that patients take to optimize their response to immunotherapy.
“We don’t want to say that the microbiome is responsible for everything, but it’s responsible for some of the response and some of the resistance to treatment,” Dr. Zarour said. “So, we want to identify what candidate nonresponders are more likely to respond to FMT and be able to stick the right stool in the donor. This goes to better education of the microbiome signature. We are working hard on that.”
Dr. Baruch added that performing FMT for melanoma patients requires tight collaborations between oncologists, dermatologists, GI, and infectious disease experts. “These usually can be done in the setting of large cancer centers and will probably not be available in any hospital,” he said. “This is why understanding the mechanisms and developing an FMT-like drug is important. We are focusing on studying the mechanisms behind the clinical effect in order to develop a drug with an FMT-like effect without the safety and logistic issues related to FMTs.”
Tamia A. Harris-Tryon, MD, PhD, whose lab at the University of Texas Southwestern Medical Center at Dallas is studying how diet and the microbiota impact skin immunity, underscored the importance of evaluating the characteristics of the diet of patients as trials of FMT in melanoma patients carry on. “We know that the diet impacts the repertoire of microbes that colonize the gut,” said Dr. Harris-Tryon, assistant professor in the department of dermatology at the medical center. “The diet of the recipient likely has an impact” on the success of donor FMT.
She also noted that other skin conditions have been linked to a disrupted gut microbiome, such as psoriasis. “Given the safety of FMT in both of these studies, trials of FMT in psoriasis and other systemic skin conditions should be considered,” she said.
According to Dr. Zarour, mounting data from separate studies show that some gut microbiota play a role in adverse events experienced by melanoma patients on immunotherapy. “That is very important, especially with combination therapy,” he said. “There are also microbes involved in resistance to treatment, so the idea would be to identify these microbes.”
Studies raise more questions
In the opinion of Dr. Greiling, results from these two studies raise more questions than they answer. “The big question ... is why and how does FMT work, and how can we make the response better?” she said. “Is there one particular gene product from one microbe that is the key magic ingredient, and we can harness this as a drug? More likely it’s a complex interplay between multiple bacterial species needed to direct the immune response. Is there a group of microbes that is the same from person to person, or is it more complex?”
Then there are pending regulatory concerns. “We know that FMT works for [Clostridioides] difficile colitis but it’s not officially [Food and Drug Administration] approved,” Dr. Greiling said. “The FDA is really struggling with how to approve or regulate using bacteria as a drug. Where is that crossover? That inhibits things moving forward, for good reason. You want to balance safety with live microbes.”
The UPMC clinical trial was supported by Merck. Dr. Zarour disclosed that he is supported by grants from the National Cancer Institute and the James W. and Frances G. McGlothlin Chair in Melanoma Immunotherapy Research at UPMC. The Israeli study was funded by the Ella Lemelbaum Institute for Immuno-Oncology. Dr. Baruch was supported by the Allen Berg Fund for Excellence in Immuno-Oncology Research. Dr. Greiling and Dr. Harris-Tryon reported having no relevant financial disclosures.
In the fall of 2020, Hassane M. Zarour, MD, and colleagues began to pore over raw data from their
Preclinical mouse studies have demonstrated that the gut microbiota could influence the response of tumors to anti–PD-1 immunotherapy, but FMT had not been previously evaluated in human patients with malignant melanoma whose disease persisted or progressed after medical therapy. Only 30%-40% of melanoma patients respond to anti–PD-1 immunotherapy, so the researchers’ sense of anticipation was palpable. “It’s a high-risk, high-reward study, so you never know,” Dr. Zarour, a dermatologist and immunologist who is coleader of the melanoma program at the University of Pittsburgh Medical Center’s Hillman Cancer Center, said in an interview.
For the study, which was funded by the National Institutes of Health and published in Science, Dr. Zarour and a team of colleagues, including Diwakar Davar, MD, a medical oncologist/hematologist at UPMC and Giorgio Trinchieri, MD, head of the cancer immunology section at the National Cancer Institute, enrolled 16 patients with advanced melanoma whose disease had persisted or progressed with anti-PD-1 drugs; donors were 7 patients with advanced melanoma who had responded to pembrolizumab, 4 with a complete response and 3 with a partial response, with a median progression-free survival of 56 months.
After donors and patients underwent serial stool sampling and studies to stamp out the potential for transmitting infectious agents, the researchers administered the donor-derived FMT to patients via colonoscopy every 14 days for 3 weeks, followed by pembrolizumab. To their delight, 6 of the 15 evaluable recipients responded to treatment, with a reduction in tumor or long-term disease stabilization. Moreover, responders also showed increased abundance of taxa that were previously associated with response to immunotherapy, increased activation of CD8+ T cells, and decreased frequency of interleukin-8–expressing myeloid cells.
“This opens new doors for the future,” Dr. Zarour said. “It’s very encouraging, but I don’t want to overstate the data. It’s a small, nonrandomized trial, but one has to keep in mind that people were skeptical about this work; they didn’t think FMT would work. Now we see many people coming into the field to investigate the role of the microbiome as a therapeutic tool, which is great.”
Teri Greiling, MD, characterized the finding as a key development in understanding the microbiome’s potential to influence the course of melanoma and other diseases. “What’s emerging over the last decade of research is that our immune system has a close, back-and-forth relationship with our microbiota,” said Dr. Greiling, associate professor of dermatology at Oregon Health & Science University, Portland. “From day 1 of birth, we’re colonized by microbes that train our immune system how to function. In response, your immune system keeps those microbes in check and shapes which ones are allowed to colonize, and which ones are a target for attack. Thus, inflammatory responses are generated. Similarly, the goal of immunotherapy is to activate the immune system to fight cancer. This study shows that the immune system continues to need the colonizing microbes in our body to function optimally.”
Immunotherapy with checkpoint inhibitors was not an option for malignant melanoma patients until 2011, she noted, so the potential for FMT to further improve outcomes is welcome news for patients and their families. “We went from a less than 5% chance of survival with metastatic melanoma to now, with the right combination of checkpoint inhibitors, we’re up over 50%, which is amazing in a decade,” Dr. Greiling said. “Still, we’re losing half of our patients. If [FMT provides] a 30% improvement over that, that would be great, but it’s hard to extrapolate from such small numbers.”
Positive results in an Israeli study
Results from a similar, smaller phase 1 trial of 2 FMT donors and 10 recipients with metastatic melanoma who had progressed on anti-PD-1 therapy, from the Ella Lemelbaum Institute for Immuno-Oncology at Sheba Medical Center in Tel HaShomer, Israel, yielded similar results. The FMT protocol in this study included colonoscopy and oral stool capsules, followed by the reintroduction of anti–PD-1 therapy with nivolumab. The two FMT donors had previously been treated with anti–PD-1 monotherapy for metastatic melanoma and had achieved a clinical response for at least 1 year. Of the 10 FMT recipients, 1 had a complete response and 2 had a partial response.
“We expected changes in the immune system but did not expect that 3 out of the 10 patients in our study would be turned from nonresponders to responders,” the study’s lead author, Erez N. Baruch, MD, PhD, told this news organization. “Since this was a first-in-human study, we were aiming to assess safety and not clinical responses. [We found] that microbiota modulation can change the immune infiltration within melanoma tumors and by this affect response to immunotherapy.”
Dr. Baruch, an internal medicine resident in the physician-scientist track program at the University of Texas, Houston, said that the findings create a potential new therapeutic paradigm, or a new “playing ground” for drug development that can support existing immunotherapies. “It is important for dermatologists to understand that disruptions of the gut microbiota, mainly by antibiotics, may be harmful to melanoma patients,” he said. “Antibiotics in cancer patients should be used judiciously but of course should not be avoided when there’s an indication.”
As for next steps, Dr. Zarour and colleagues are recruiting more patients to boost their sample size and conducting sequential analysis of the microbiome of study participants “to better determine what the good and bad bugs are,” he said. “There are so many variables, including diet and geography. We need more data.” The hope is to develop a “microbiome signature” to identify patients likely to respond to FMT, and maybe one day, a probiotic capsule that patients take to optimize their response to immunotherapy.
“We don’t want to say that the microbiome is responsible for everything, but it’s responsible for some of the response and some of the resistance to treatment,” Dr. Zarour said. “So, we want to identify what candidate nonresponders are more likely to respond to FMT and be able to stick the right stool in the donor. This goes to better education of the microbiome signature. We are working hard on that.”
Dr. Baruch added that performing FMT for melanoma patients requires tight collaborations between oncologists, dermatologists, GI, and infectious disease experts. “These usually can be done in the setting of large cancer centers and will probably not be available in any hospital,” he said. “This is why understanding the mechanisms and developing an FMT-like drug is important. We are focusing on studying the mechanisms behind the clinical effect in order to develop a drug with an FMT-like effect without the safety and logistic issues related to FMTs.”
Tamia A. Harris-Tryon, MD, PhD, whose lab at the University of Texas Southwestern Medical Center at Dallas is studying how diet and the microbiota impact skin immunity, underscored the importance of evaluating the characteristics of the diet of patients as trials of FMT in melanoma patients carry on. “We know that the diet impacts the repertoire of microbes that colonize the gut,” said Dr. Harris-Tryon, assistant professor in the department of dermatology at the medical center. “The diet of the recipient likely has an impact” on the success of donor FMT.
She also noted that other skin conditions have been linked to a disrupted gut microbiome, such as psoriasis. “Given the safety of FMT in both of these studies, trials of FMT in psoriasis and other systemic skin conditions should be considered,” she said.
According to Dr. Zarour, mounting data from separate studies show that some gut microbiota play a role in adverse events experienced by melanoma patients on immunotherapy. “That is very important, especially with combination therapy,” he said. “There are also microbes involved in resistance to treatment, so the idea would be to identify these microbes.”
Studies raise more questions
In the opinion of Dr. Greiling, results from these two studies raise more questions than they answer. “The big question ... is why and how does FMT work, and how can we make the response better?” she said. “Is there one particular gene product from one microbe that is the key magic ingredient, and we can harness this as a drug? More likely it’s a complex interplay between multiple bacterial species needed to direct the immune response. Is there a group of microbes that is the same from person to person, or is it more complex?”
Then there are pending regulatory concerns. “We know that FMT works for [Clostridioides] difficile colitis but it’s not officially [Food and Drug Administration] approved,” Dr. Greiling said. “The FDA is really struggling with how to approve or regulate using bacteria as a drug. Where is that crossover? That inhibits things moving forward, for good reason. You want to balance safety with live microbes.”
The UPMC clinical trial was supported by Merck. Dr. Zarour disclosed that he is supported by grants from the National Cancer Institute and the James W. and Frances G. McGlothlin Chair in Melanoma Immunotherapy Research at UPMC. The Israeli study was funded by the Ella Lemelbaum Institute for Immuno-Oncology. Dr. Baruch was supported by the Allen Berg Fund for Excellence in Immuno-Oncology Research. Dr. Greiling and Dr. Harris-Tryon reported having no relevant financial disclosures.
CrossFit enters primary care with fitness-minded docs, data
with the launch of its newest service, CrossFit Precision Care.
Developed by family medicine physician Julie Foucher, MD, and other CrossFit-trained doctors, the new service aims to help CrossFit members build plans to protect and improve their health, according to a statement by the company.
CrossFit Precision Care plans to meet this goal through utilizing doctors who understand the CrossFit philosophy, individualized care, data-driven recommendations, proactive lifestyle changes, and continual health optimization. Informing these plans and changes are CrossFit Precision Care’s analysis through a few different methods.
CrossFit’s partner in the endeavor, Wild Health, will provide genomic testing to determine a patient’s genetic predispositions to help optimize the health plans. Blood testing reveals many things that may affect a person’s health, such as hormone status, lipid levels, thyroid function, and cardiovascular risks. An overall lifestyle review includes exercise routines, eating habits, social life, and other patterns or behaviors.
Connecting with doctors who understand CrossFit
Dr. Foucher is no stranger to CrossFit. She has competed in the CrossFit Games four times and discusses the sport regularly on Twitter and Instagram. Now, she works directly with CrossFit to help it provide users with individualized data-driven plans.
“I met Eric Roza last July,” Dr. Foucher says of CrossFit’s CEO. “We talked and saw a lot of potential for CrossFit and health care providers to work together, so we started brainstorming.”
When Dr. Foucher and Mr. Roza got to know Wild Health, specifically, two of its physician cofounders, it was a natural fit, she said. Dr. Foucher says that many who train in CrossFit or go to CrossFit-affiliated gyms feel a disconnect with their family doctors: “[CrossFit is] a pretty polarizing topic, but there are also a lot of doctors who know that people are having health improvements with these programs,” she said.
Through use of Wild Health’s precision services and algorithms, CrossFit Precision Care plans to connect its users with CrossFit-trained health care practitioners. This personalized approach allows health care practitioners to build closer relationships with users of the program, who may feel more comfortable working with doctors who understand their lifestyle. Wild Health’s precision medicine approach, with trackable data such as biomarker status and risk scores, gives doctors a more complete picture of a patient’s needs and history, according to a statement on the partnership.
A better use of data
“To me,” Dr. Foucher says of family medicine, “that was the best option coming out of residency. It was consistent with my morals.” She says much of the current health care system is algorithm based. If a patient is experiencing certain symptoms, treatment is recommended on the basis of whatever yields the best results from the data – but this doesn’t always factor in a patient’s full history and genetics. It can be difficult for doctors to build trusting and personal relationships with patients. “In our current system, there’s not a lot of time or great tools to do that,” she says.
With the approach Wild Health and CrossFit Precision Care both use, however, Dr. Foucher says she sees a huge opportunity for optimizing patient and health care practitioner relationships.
“I see huge potential here, and I really think that this should be the standard for primary care going forwards,” Dr. Foucher explains. “The nice thing about [this approach] is that it has a really quick learning curve and is relatively easy to implement with patients. Before Wild Health optimized it, the tech and data would take about 10 hours per patient to put together. But now, we can incorporate things that work with wearable tech and track results over time and allow the patient and doctor to use this platform to create relationships. And this is something that can scale to many more patients.”
According to its website, CrossFit Precision Care is currently launching an invite-only beta test version of the program in eight states ahead of an expected national release.
A version of this article first appeared on Medscape.com.
with the launch of its newest service, CrossFit Precision Care.
Developed by family medicine physician Julie Foucher, MD, and other CrossFit-trained doctors, the new service aims to help CrossFit members build plans to protect and improve their health, according to a statement by the company.
CrossFit Precision Care plans to meet this goal through utilizing doctors who understand the CrossFit philosophy, individualized care, data-driven recommendations, proactive lifestyle changes, and continual health optimization. Informing these plans and changes are CrossFit Precision Care’s analysis through a few different methods.
CrossFit’s partner in the endeavor, Wild Health, will provide genomic testing to determine a patient’s genetic predispositions to help optimize the health plans. Blood testing reveals many things that may affect a person’s health, such as hormone status, lipid levels, thyroid function, and cardiovascular risks. An overall lifestyle review includes exercise routines, eating habits, social life, and other patterns or behaviors.
Connecting with doctors who understand CrossFit
Dr. Foucher is no stranger to CrossFit. She has competed in the CrossFit Games four times and discusses the sport regularly on Twitter and Instagram. Now, she works directly with CrossFit to help it provide users with individualized data-driven plans.
“I met Eric Roza last July,” Dr. Foucher says of CrossFit’s CEO. “We talked and saw a lot of potential for CrossFit and health care providers to work together, so we started brainstorming.”
When Dr. Foucher and Mr. Roza got to know Wild Health, specifically, two of its physician cofounders, it was a natural fit, she said. Dr. Foucher says that many who train in CrossFit or go to CrossFit-affiliated gyms feel a disconnect with their family doctors: “[CrossFit is] a pretty polarizing topic, but there are also a lot of doctors who know that people are having health improvements with these programs,” she said.
Through use of Wild Health’s precision services and algorithms, CrossFit Precision Care plans to connect its users with CrossFit-trained health care practitioners. This personalized approach allows health care practitioners to build closer relationships with users of the program, who may feel more comfortable working with doctors who understand their lifestyle. Wild Health’s precision medicine approach, with trackable data such as biomarker status and risk scores, gives doctors a more complete picture of a patient’s needs and history, according to a statement on the partnership.
A better use of data
“To me,” Dr. Foucher says of family medicine, “that was the best option coming out of residency. It was consistent with my morals.” She says much of the current health care system is algorithm based. If a patient is experiencing certain symptoms, treatment is recommended on the basis of whatever yields the best results from the data – but this doesn’t always factor in a patient’s full history and genetics. It can be difficult for doctors to build trusting and personal relationships with patients. “In our current system, there’s not a lot of time or great tools to do that,” she says.
With the approach Wild Health and CrossFit Precision Care both use, however, Dr. Foucher says she sees a huge opportunity for optimizing patient and health care practitioner relationships.
“I see huge potential here, and I really think that this should be the standard for primary care going forwards,” Dr. Foucher explains. “The nice thing about [this approach] is that it has a really quick learning curve and is relatively easy to implement with patients. Before Wild Health optimized it, the tech and data would take about 10 hours per patient to put together. But now, we can incorporate things that work with wearable tech and track results over time and allow the patient and doctor to use this platform to create relationships. And this is something that can scale to many more patients.”
According to its website, CrossFit Precision Care is currently launching an invite-only beta test version of the program in eight states ahead of an expected national release.
A version of this article first appeared on Medscape.com.
with the launch of its newest service, CrossFit Precision Care.
Developed by family medicine physician Julie Foucher, MD, and other CrossFit-trained doctors, the new service aims to help CrossFit members build plans to protect and improve their health, according to a statement by the company.
CrossFit Precision Care plans to meet this goal through utilizing doctors who understand the CrossFit philosophy, individualized care, data-driven recommendations, proactive lifestyle changes, and continual health optimization. Informing these plans and changes are CrossFit Precision Care’s analysis through a few different methods.
CrossFit’s partner in the endeavor, Wild Health, will provide genomic testing to determine a patient’s genetic predispositions to help optimize the health plans. Blood testing reveals many things that may affect a person’s health, such as hormone status, lipid levels, thyroid function, and cardiovascular risks. An overall lifestyle review includes exercise routines, eating habits, social life, and other patterns or behaviors.
Connecting with doctors who understand CrossFit
Dr. Foucher is no stranger to CrossFit. She has competed in the CrossFit Games four times and discusses the sport regularly on Twitter and Instagram. Now, she works directly with CrossFit to help it provide users with individualized data-driven plans.
“I met Eric Roza last July,” Dr. Foucher says of CrossFit’s CEO. “We talked and saw a lot of potential for CrossFit and health care providers to work together, so we started brainstorming.”
When Dr. Foucher and Mr. Roza got to know Wild Health, specifically, two of its physician cofounders, it was a natural fit, she said. Dr. Foucher says that many who train in CrossFit or go to CrossFit-affiliated gyms feel a disconnect with their family doctors: “[CrossFit is] a pretty polarizing topic, but there are also a lot of doctors who know that people are having health improvements with these programs,” she said.
Through use of Wild Health’s precision services and algorithms, CrossFit Precision Care plans to connect its users with CrossFit-trained health care practitioners. This personalized approach allows health care practitioners to build closer relationships with users of the program, who may feel more comfortable working with doctors who understand their lifestyle. Wild Health’s precision medicine approach, with trackable data such as biomarker status and risk scores, gives doctors a more complete picture of a patient’s needs and history, according to a statement on the partnership.
A better use of data
“To me,” Dr. Foucher says of family medicine, “that was the best option coming out of residency. It was consistent with my morals.” She says much of the current health care system is algorithm based. If a patient is experiencing certain symptoms, treatment is recommended on the basis of whatever yields the best results from the data – but this doesn’t always factor in a patient’s full history and genetics. It can be difficult for doctors to build trusting and personal relationships with patients. “In our current system, there’s not a lot of time or great tools to do that,” she says.
With the approach Wild Health and CrossFit Precision Care both use, however, Dr. Foucher says she sees a huge opportunity for optimizing patient and health care practitioner relationships.
“I see huge potential here, and I really think that this should be the standard for primary care going forwards,” Dr. Foucher explains. “The nice thing about [this approach] is that it has a really quick learning curve and is relatively easy to implement with patients. Before Wild Health optimized it, the tech and data would take about 10 hours per patient to put together. But now, we can incorporate things that work with wearable tech and track results over time and allow the patient and doctor to use this platform to create relationships. And this is something that can scale to many more patients.”
According to its website, CrossFit Precision Care is currently launching an invite-only beta test version of the program in eight states ahead of an expected national release.
A version of this article first appeared on Medscape.com.
Resident physician work-hour regulations associated with improved physician safety and health
Background: In 2011, the Accreditation Council for Graduate Medical Education (ACGME) enacted a consecutive work-hour restriction of 16 hours for first-year residents. Reports of these changes have focused on patient safety, resident education, and resident well-being. The impact on resident safety had not been addressed.
Study design: Prospective cohort study.
Setting: U.S. Academic institutions training resident physicians.
Synopsis: This study compared first-year resident physicians from 2002 to 2007 (pre-implementation) and 2014 to 2017 (post-implementation). In all, 5,680 pre-implementation residents and 9,596 post-implementation residents consented to the study. With the 2011 ACGME restriction, the risk of motor vehicle crash decreased 24% (relative risk [RR] .76; .67-.85), and percutaneous injury risk decreased more than 40% (RR .54; .48-.61). Although weekly work hours were significantly higher pre-implementation, self-reported hours involved in patient care were similar for both groups.
While this large, well-powered study suggests extended work-hour restrictions for resident physicians improve their safety, the study is limited by self-reporting of resident physicians. As the ACGME has re-introduced extended duration shifts for first-year resident physicians, hospitalists should advocate for objective physician safety studies in relation to extended-hour shifts.
Bottom line: The 2011 ACGME work-hour reform for first-year physicians improved their safety and health.
Citation: Weaver MD et al. The association between resident physician work-hour regulations and physician safety and health. Am J Med. 2020 July;133(7):e343-54.
Dr. Fletcher is a hospitalist at the Lexington (Ky.) VA Health Care System.
Background: In 2011, the Accreditation Council for Graduate Medical Education (ACGME) enacted a consecutive work-hour restriction of 16 hours for first-year residents. Reports of these changes have focused on patient safety, resident education, and resident well-being. The impact on resident safety had not been addressed.
Study design: Prospective cohort study.
Setting: U.S. Academic institutions training resident physicians.
Synopsis: This study compared first-year resident physicians from 2002 to 2007 (pre-implementation) and 2014 to 2017 (post-implementation). In all, 5,680 pre-implementation residents and 9,596 post-implementation residents consented to the study. With the 2011 ACGME restriction, the risk of motor vehicle crash decreased 24% (relative risk [RR] .76; .67-.85), and percutaneous injury risk decreased more than 40% (RR .54; .48-.61). Although weekly work hours were significantly higher pre-implementation, self-reported hours involved in patient care were similar for both groups.
While this large, well-powered study suggests extended work-hour restrictions for resident physicians improve their safety, the study is limited by self-reporting of resident physicians. As the ACGME has re-introduced extended duration shifts for first-year resident physicians, hospitalists should advocate for objective physician safety studies in relation to extended-hour shifts.
Bottom line: The 2011 ACGME work-hour reform for first-year physicians improved their safety and health.
Citation: Weaver MD et al. The association between resident physician work-hour regulations and physician safety and health. Am J Med. 2020 July;133(7):e343-54.
Dr. Fletcher is a hospitalist at the Lexington (Ky.) VA Health Care System.
Background: In 2011, the Accreditation Council for Graduate Medical Education (ACGME) enacted a consecutive work-hour restriction of 16 hours for first-year residents. Reports of these changes have focused on patient safety, resident education, and resident well-being. The impact on resident safety had not been addressed.
Study design: Prospective cohort study.
Setting: U.S. Academic institutions training resident physicians.
Synopsis: This study compared first-year resident physicians from 2002 to 2007 (pre-implementation) and 2014 to 2017 (post-implementation). In all, 5,680 pre-implementation residents and 9,596 post-implementation residents consented to the study. With the 2011 ACGME restriction, the risk of motor vehicle crash decreased 24% (relative risk [RR] .76; .67-.85), and percutaneous injury risk decreased more than 40% (RR .54; .48-.61). Although weekly work hours were significantly higher pre-implementation, self-reported hours involved in patient care were similar for both groups.
While this large, well-powered study suggests extended work-hour restrictions for resident physicians improve their safety, the study is limited by self-reporting of resident physicians. As the ACGME has re-introduced extended duration shifts for first-year resident physicians, hospitalists should advocate for objective physician safety studies in relation to extended-hour shifts.
Bottom line: The 2011 ACGME work-hour reform for first-year physicians improved their safety and health.
Citation: Weaver MD et al. The association between resident physician work-hour regulations and physician safety and health. Am J Med. 2020 July;133(7):e343-54.
Dr. Fletcher is a hospitalist at the Lexington (Ky.) VA Health Care System.
Product News October 2021
Opzelura FDA Approved for Atopic Dermatitis Incyte
Corporation announces US Food and Drug Administration (FDA) approval of Opzelura (ruxolitinib) cream 1.5% for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Opzelura is formulated with ruxolitinib, a selective Janus kinase (JAK) 1/JAK2 inhibitor, to target key cytokine signals believed to contribute to itch and inflammation. For more information, visit www.opzelurahcp.com/.
Twyneo FDA Approved for Acne Vulgaris
Sol-Gel Technologies, Ltd, announces US Food and Drug Administration (FDA) approval of Twyneo (tretinoin 0.1% /benzoyl peroxide 3%) cream for the treatment of acne vulgaris in adult and pediatric patients 9 years and older. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The formulation of Twyneo uses silica (silicon dioxide) core shell structures to separately microencapsulate tretinoin crystals and benzoyl peroxide crystals, enabling inclusion of the 2 active ingredients in the cream. For more information, visit www.sol-gel.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Opzelura FDA Approved for Atopic Dermatitis Incyte
Corporation announces US Food and Drug Administration (FDA) approval of Opzelura (ruxolitinib) cream 1.5% for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Opzelura is formulated with ruxolitinib, a selective Janus kinase (JAK) 1/JAK2 inhibitor, to target key cytokine signals believed to contribute to itch and inflammation. For more information, visit www.opzelurahcp.com/.
Twyneo FDA Approved for Acne Vulgaris
Sol-Gel Technologies, Ltd, announces US Food and Drug Administration (FDA) approval of Twyneo (tretinoin 0.1% /benzoyl peroxide 3%) cream for the treatment of acne vulgaris in adult and pediatric patients 9 years and older. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The formulation of Twyneo uses silica (silicon dioxide) core shell structures to separately microencapsulate tretinoin crystals and benzoyl peroxide crystals, enabling inclusion of the 2 active ingredients in the cream. For more information, visit www.sol-gel.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Opzelura FDA Approved for Atopic Dermatitis Incyte
Corporation announces US Food and Drug Administration (FDA) approval of Opzelura (ruxolitinib) cream 1.5% for the short-term and noncontinuous chronic treatment of mild to moderate atopic dermatitis (AD) in nonimmunocompromised patients 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Opzelura is formulated with ruxolitinib, a selective Janus kinase (JAK) 1/JAK2 inhibitor, to target key cytokine signals believed to contribute to itch and inflammation. For more information, visit www.opzelurahcp.com/.
Twyneo FDA Approved for Acne Vulgaris
Sol-Gel Technologies, Ltd, announces US Food and Drug Administration (FDA) approval of Twyneo (tretinoin 0.1% /benzoyl peroxide 3%) cream for the treatment of acne vulgaris in adult and pediatric patients 9 years and older. Tretinoin and benzoyl peroxide are widely prescribed separately for acne vulgaris; however, benzoyl peroxide causes degradation of the tretinoin molecule, thereby potentially reducing its effectiveness if used at the same time or combined in the same formulation. The formulation of Twyneo uses silica (silicon dioxide) core shell structures to separately microencapsulate tretinoin crystals and benzoyl peroxide crystals, enabling inclusion of the 2 active ingredients in the cream. For more information, visit www.sol-gel.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].