Mixed Topics

Dear colleagues,

I’m thrilled to introduce the August edition of The New Gastroenterologist, which features an excellent line-up of articles! Summer has been in full swing, and gradually, we eased into aspects of our prepandemic routine. The fear, caution, and isolation that characterized the last year and a half was less pervasive, and the ability to reconnect in person felt both refreshing and liberating. While new threats of variants and rising infection rates have emerged, there is hope that, with the availability of vaccines, the worst of the pandemic may still be behind us.

One of the most difficult aspects of treating patients with inflammatory bowel disease is acute pain management. Dr. Jami Kinnucan and Dr. Mehwish Ahmed (University of Michigan) outline an expert approach on differentiating between visceral and somatic pain and how to manage each accordingly.

The diagnosis of microscopic colitis can be elusive because colonic mucosa typically appears endoscopically normal and the pathognomonic findings are histologic. Management can also be challenging given the frequently relapsing and remitting nature of its clinical course. The “In Focus” feature for August, written by Dr. June Tome, Dr. Amrit Kamboj, and Dr. Darrell Pardi (Mayo Clinic), is an absolute must-read as it provides a detailed review on the diagnosis, management, and therapeutic options for microscopic colitis.

As gastroenterologists, we are often asked to place percutaneous endoscopic gastrostomy (PEG) tubes. This can be a difficult situation to navigate especially when the indication or timing of placement seems questionable. In our ethics case for this quarter, Dr. David Seres and Dr. Jane Cowan (Columbia University) unpack the ethical considerations of PEG tube placement in order to facilitate discharge to subacute nursing facilities.

Months in quarantine have incited many to crave larger living spaces, lending to a chaotic housing market. Jon Solitro (FinancialMD) offers sound financial advice for physicians interested purchasing a home – including factors to consider when choosing a home, how much to spend, and whether or not to consider a doctor’s loan.

Success in research can be particularly difficult for fellows and early career gastroenterologists as they juggle the many responsibilities inherent to busy training programs or adjust to independent practice. Dr. Dionne Rebello and Dr. Michelle Long (Boston University) compile a list of incredibly helpful tips on how to optimize productivity. For those interested in ways to harness experiences in clinical medicine into health technology, Dr. Simon Matthews (Johns Hopkins) discusses his role as chief medical officer in a health tech start-up in our postfellowship pathways section.

Lastly, our DHPA Private Practice Perspectives article, written by Dr. George Dickstein (Greater Boston Gastroenterology), nicely summarizes lessons learned from the pandemic and how a practice can be adequately prepared for a post-pandemic surge of procedures.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.

Stay well,

Vijaya L. Rao, MD
Editor in Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

I’m thrilled to introduce the August edition of The New Gastroenterologist, which features an excellent line-up of articles! Summer has been in full swing, and gradually, we eased into aspects of our prepandemic routine. The fear, caution, and isolation that characterized the last year and a half was less pervasive, and the ability to reconnect in person felt both refreshing and liberating. While new threats of variants and rising infection rates have emerged, there is hope that, with the availability of vaccines, the worst of the pandemic may still be behind us.

One of the most difficult aspects of treating patients with inflammatory bowel disease is acute pain management. Dr. Jami Kinnucan and Dr. Mehwish Ahmed (University of Michigan) outline an expert approach on differentiating between visceral and somatic pain and how to manage each accordingly.

The diagnosis of microscopic colitis can be elusive because colonic mucosa typically appears endoscopically normal and the pathognomonic findings are histologic. Management can also be challenging given the frequently relapsing and remitting nature of its clinical course. The “In Focus” feature for August, written by Dr. June Tome, Dr. Amrit Kamboj, and Dr. Darrell Pardi (Mayo Clinic), is an absolute must-read as it provides a detailed review on the diagnosis, management, and therapeutic options for microscopic colitis.

As gastroenterologists, we are often asked to place percutaneous endoscopic gastrostomy (PEG) tubes. This can be a difficult situation to navigate especially when the indication or timing of placement seems questionable. In our ethics case for this quarter, Dr. David Seres and Dr. Jane Cowan (Columbia University) unpack the ethical considerations of PEG tube placement in order to facilitate discharge to subacute nursing facilities.

Months in quarantine have incited many to crave larger living spaces, lending to a chaotic housing market. Jon Solitro (FinancialMD) offers sound financial advice for physicians interested purchasing a home – including factors to consider when choosing a home, how much to spend, and whether or not to consider a doctor’s loan.

Success in research can be particularly difficult for fellows and early career gastroenterologists as they juggle the many responsibilities inherent to busy training programs or adjust to independent practice. Dr. Dionne Rebello and Dr. Michelle Long (Boston University) compile a list of incredibly helpful tips on how to optimize productivity. For those interested in ways to harness experiences in clinical medicine into health technology, Dr. Simon Matthews (Johns Hopkins) discusses his role as chief medical officer in a health tech start-up in our postfellowship pathways section.

Lastly, our DHPA Private Practice Perspectives article, written by Dr. George Dickstein (Greater Boston Gastroenterology), nicely summarizes lessons learned from the pandemic and how a practice can be adequately prepared for a post-pandemic surge of procedures.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.

Stay well,

Vijaya L. Rao, MD
Editor in Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

I’m thrilled to introduce the August edition of The New Gastroenterologist, which features an excellent line-up of articles! Summer has been in full swing, and gradually, we eased into aspects of our prepandemic routine. The fear, caution, and isolation that characterized the last year and a half was less pervasive, and the ability to reconnect in person felt both refreshing and liberating. While new threats of variants and rising infection rates have emerged, there is hope that, with the availability of vaccines, the worst of the pandemic may still be behind us.

One of the most difficult aspects of treating patients with inflammatory bowel disease is acute pain management. Dr. Jami Kinnucan and Dr. Mehwish Ahmed (University of Michigan) outline an expert approach on differentiating between visceral and somatic pain and how to manage each accordingly.

The diagnosis of microscopic colitis can be elusive because colonic mucosa typically appears endoscopically normal and the pathognomonic findings are histologic. Management can also be challenging given the frequently relapsing and remitting nature of its clinical course. The “In Focus” feature for August, written by Dr. June Tome, Dr. Amrit Kamboj, and Dr. Darrell Pardi (Mayo Clinic), is an absolute must-read as it provides a detailed review on the diagnosis, management, and therapeutic options for microscopic colitis.

As gastroenterologists, we are often asked to place percutaneous endoscopic gastrostomy (PEG) tubes. This can be a difficult situation to navigate especially when the indication or timing of placement seems questionable. In our ethics case for this quarter, Dr. David Seres and Dr. Jane Cowan (Columbia University) unpack the ethical considerations of PEG tube placement in order to facilitate discharge to subacute nursing facilities.

Months in quarantine have incited many to crave larger living spaces, lending to a chaotic housing market. Jon Solitro (FinancialMD) offers sound financial advice for physicians interested purchasing a home – including factors to consider when choosing a home, how much to spend, and whether or not to consider a doctor’s loan.

Success in research can be particularly difficult for fellows and early career gastroenterologists as they juggle the many responsibilities inherent to busy training programs or adjust to independent practice. Dr. Dionne Rebello and Dr. Michelle Long (Boston University) compile a list of incredibly helpful tips on how to optimize productivity. For those interested in ways to harness experiences in clinical medicine into health technology, Dr. Simon Matthews (Johns Hopkins) discusses his role as chief medical officer in a health tech start-up in our postfellowship pathways section.

Lastly, our DHPA Private Practice Perspectives article, written by Dr. George Dickstein (Greater Boston Gastroenterology), nicely summarizes lessons learned from the pandemic and how a practice can be adequately prepared for a post-pandemic surge of procedures.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]) or Ryan Farrell ([email protected]), managing editor of TNG.

Stay well,

Vijaya L. Rao, MD
Editor in Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Gastroenterology

May 2021
Understanding GI Twitter and its major contributors. Elfanagely Y et al. Gastroenterology. 2021 May;160(6):1917-21. doi: 10.1053/j.gastro.2021.01.232.

Long-term safety of fecal microbiota transplantation for recurrent Clostridioides difficile infection. Saha S et al. Gastroenterology. 2021 May;160(6):1961-9.e3. doi: 10.1053/j.gastro.2021.01.010.

How to incorporate health equity training into gastroenterology and hepatology fellowships. Lee-Allen J, Shah BJ. Gastroenterology. 2021 May;160(6):1924-8. doi: 10.1053/j.gastro.2021.03.018.

Functional dyspepsia and gastroparesis in tertiary care are interchangeable syndromes with common clinical and pathologic features. Pasricha PJ et al. Gastroenterology. 2021 May;160(6):2006-17. doi: 10.1053/j.gastro.2021.01.230.

June 2021
How to manage the large nonpedunculated colorectal polyp. Shahidi N, Bourke MJ. Gastroenterology. 2021 Jun;160(7):2239-43.e1. doi: 10.1053/j.gastro.2021.04.029.

Mortality, reoperation, and hospital stay within 90 days of primary and secondary antireflux surgery in a population-based multinational study. Yanes M et al. Gastroenterology. 2021 Jun;160(7):2283-90. doi: 10.1053/j.gastro.2021.02.022.

Endoscopic submucosal dissection in north america: A large prospective multicenter study. Draganov PV et al. Gastroenterology. 2021 Jun;160(7):2317-27.e2. doi: 10.1053/j.gastro.2021.02.036.

July 2021
Gluten degradation, pharmacokinetics, safety, and tolerability of TAK-062, an engineered enzyme to treat celiac disease. Pultz IG et al. Gastroenterology. 2021 Jul;161(1):81-93.e3. doi: 10.1053/j.gastro.2021.03.019.

Paternal exposure to immunosuppressive and/or biologic agents and birth outcomes in patients with immune-mediated inflammatory diseases. Meserve J et al. Gastroenterology. 2021 Jul;161(1):107-115.e3. doi: 10.1053/j.gastro.2021.03.020.

Ethnicity associations with food sensitization are mediated by gut microbiota development in the first year of life. Tun Hm et al. Gastroenterology. 2021 Jul;161(1):94-106. doi: 10.1053/j.gastro.2021.03.016.

How to incorporate bariatric training into your fellowship program. Jirapinyo P, Thompson CC. Gastroenterology. 2019 Jul;157(1):9-13. doi: 10.1053/j.gastro.2019.05.034.

CGH

May 2021
Intestinal failure: What all gastroenterologists should know. Jansson-Knodell CL et al. Clin Gastroenterol Hepatol. 2021 May;19(5):885-8. doi: 10.1016/j.cgh.2021.01.038.

When and how to use endoscopic tattooing in the colon: An international Delphi agreement. Medina-Prado L et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1038-50. doi: 10.1016/j.cgh.2021.01.024.

Five-year outcomes of endoscopic sleeve gastroplasty for the treatment of obesity. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1051-57.e2. doi: 10.1016/j.cgh.2020.09.055.

June 2021
GA Clinical Practice Update on management of bleeding gastric varices: Expert review. Henry Z et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1098-107.e1. doi: 10.1016/j.cgh.2021.01.027.

Inter- and intra-individual variation, and limited prognostic utility, of serum alkaline phosphatase in a trial of patients with primary sclerosing cholangitis

Palak J. Trivedi PJ et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1248-57. doi: 10.1016/j.cgh.2020.07.032.

Low-fat, high-fiber diet reduces markers of inflammation and dysbiosis and improves quality of life in patients with ulcerative colitis. Julia Fritsch J et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-99.e30. doi: 10.1016/j.cgh.2020.05.026.

July 2021
Scoping out a better parental leave policy for gastroenterology fellows. Wegermann K. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1307-9. doi: 10.1016/j.cgh.2021.01.040.

An impetus for change: How COVID-19 will transform the delivery of GI health care. Leiman DA et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1310-1313. doi: 10.1016/j.cgh.2021.03.042.

Untangling nonerosive reflux disease from functional heartburn. Patel D et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1314-26. doi: 10.1016/j.cgh.2020.03.057.
 

AGA Clinical Practice Update on chemoprevention for colorectal neoplasia: Expert review. Liang PS et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1327-36. doi: 10.1016/j.cgh.2021.02.014.
 

CMGH

Drug inhibition of SARS-CoV-2 replication in human pluripotent stem cell–derived intestinal organoids. Krüger J et al. Cell Mol Gastroenterol Hepatol. 2021;11(4):935-48. doi: 10.1016/j.jcmgh.2020.11.003.
 

TIGE

Virtual interviews during the COVID-19 Pandemic: A survey of advanced endoscopy fellowship applicants and programs. Amrit K. Kamboj AK et al. Tech Innov Gastrointest Endosc. 2021;23(2):159-68. doi: 10.1016/j.tige.2021.02.001.

Triage of general gastrointestinal endoscopic procedures during the COVID-19 pandemic: Results from a national Delphi consensus panel. Feuerstein JD et al. Tech Innov Gastrointest Endosc. 2021;23(2):113-21. doi: 10.1016/j.tige.2020.12.005.

Development of a scoring system to predict a positive diagnosis on video capsule endoscopy for suspected small bowel bleeding. Marya NB et al. Tech Innov Gastrointest Endosc. 2021;22(4):178-84. doi: 10.1016/j.tige.2020.06.001.

Gastroenterology

May 2021
Understanding GI Twitter and its major contributors. Elfanagely Y et al. Gastroenterology. 2021 May;160(6):1917-21. doi: 10.1053/j.gastro.2021.01.232.

Long-term safety of fecal microbiota transplantation for recurrent Clostridioides difficile infection. Saha S et al. Gastroenterology. 2021 May;160(6):1961-9.e3. doi: 10.1053/j.gastro.2021.01.010.

How to incorporate health equity training into gastroenterology and hepatology fellowships. Lee-Allen J, Shah BJ. Gastroenterology. 2021 May;160(6):1924-8. doi: 10.1053/j.gastro.2021.03.018.

Functional dyspepsia and gastroparesis in tertiary care are interchangeable syndromes with common clinical and pathologic features. Pasricha PJ et al. Gastroenterology. 2021 May;160(6):2006-17. doi: 10.1053/j.gastro.2021.01.230.

June 2021
How to manage the large nonpedunculated colorectal polyp. Shahidi N, Bourke MJ. Gastroenterology. 2021 Jun;160(7):2239-43.e1. doi: 10.1053/j.gastro.2021.04.029.

Mortality, reoperation, and hospital stay within 90 days of primary and secondary antireflux surgery in a population-based multinational study. Yanes M et al. Gastroenterology. 2021 Jun;160(7):2283-90. doi: 10.1053/j.gastro.2021.02.022.

Endoscopic submucosal dissection in north america: A large prospective multicenter study. Draganov PV et al. Gastroenterology. 2021 Jun;160(7):2317-27.e2. doi: 10.1053/j.gastro.2021.02.036.

July 2021
Gluten degradation, pharmacokinetics, safety, and tolerability of TAK-062, an engineered enzyme to treat celiac disease. Pultz IG et al. Gastroenterology. 2021 Jul;161(1):81-93.e3. doi: 10.1053/j.gastro.2021.03.019.

Paternal exposure to immunosuppressive and/or biologic agents and birth outcomes in patients with immune-mediated inflammatory diseases. Meserve J et al. Gastroenterology. 2021 Jul;161(1):107-115.e3. doi: 10.1053/j.gastro.2021.03.020.

Ethnicity associations with food sensitization are mediated by gut microbiota development in the first year of life. Tun Hm et al. Gastroenterology. 2021 Jul;161(1):94-106. doi: 10.1053/j.gastro.2021.03.016.

How to incorporate bariatric training into your fellowship program. Jirapinyo P, Thompson CC. Gastroenterology. 2019 Jul;157(1):9-13. doi: 10.1053/j.gastro.2019.05.034.

CGH

May 2021
Intestinal failure: What all gastroenterologists should know. Jansson-Knodell CL et al. Clin Gastroenterol Hepatol. 2021 May;19(5):885-8. doi: 10.1016/j.cgh.2021.01.038.

When and how to use endoscopic tattooing in the colon: An international Delphi agreement. Medina-Prado L et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1038-50. doi: 10.1016/j.cgh.2021.01.024.

Five-year outcomes of endoscopic sleeve gastroplasty for the treatment of obesity. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1051-57.e2. doi: 10.1016/j.cgh.2020.09.055.

June 2021
GA Clinical Practice Update on management of bleeding gastric varices: Expert review. Henry Z et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1098-107.e1. doi: 10.1016/j.cgh.2021.01.027.

Inter- and intra-individual variation, and limited prognostic utility, of serum alkaline phosphatase in a trial of patients with primary sclerosing cholangitis

Palak J. Trivedi PJ et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1248-57. doi: 10.1016/j.cgh.2020.07.032.

Low-fat, high-fiber diet reduces markers of inflammation and dysbiosis and improves quality of life in patients with ulcerative colitis. Julia Fritsch J et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-99.e30. doi: 10.1016/j.cgh.2020.05.026.

July 2021
Scoping out a better parental leave policy for gastroenterology fellows. Wegermann K. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1307-9. doi: 10.1016/j.cgh.2021.01.040.

An impetus for change: How COVID-19 will transform the delivery of GI health care. Leiman DA et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1310-1313. doi: 10.1016/j.cgh.2021.03.042.

Untangling nonerosive reflux disease from functional heartburn. Patel D et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1314-26. doi: 10.1016/j.cgh.2020.03.057.
 

AGA Clinical Practice Update on chemoprevention for colorectal neoplasia: Expert review. Liang PS et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1327-36. doi: 10.1016/j.cgh.2021.02.014.
 

CMGH

Drug inhibition of SARS-CoV-2 replication in human pluripotent stem cell–derived intestinal organoids. Krüger J et al. Cell Mol Gastroenterol Hepatol. 2021;11(4):935-48. doi: 10.1016/j.jcmgh.2020.11.003.
 

TIGE

Virtual interviews during the COVID-19 Pandemic: A survey of advanced endoscopy fellowship applicants and programs. Amrit K. Kamboj AK et al. Tech Innov Gastrointest Endosc. 2021;23(2):159-68. doi: 10.1016/j.tige.2021.02.001.

Triage of general gastrointestinal endoscopic procedures during the COVID-19 pandemic: Results from a national Delphi consensus panel. Feuerstein JD et al. Tech Innov Gastrointest Endosc. 2021;23(2):113-21. doi: 10.1016/j.tige.2020.12.005.

Development of a scoring system to predict a positive diagnosis on video capsule endoscopy for suspected small bowel bleeding. Marya NB et al. Tech Innov Gastrointest Endosc. 2021;22(4):178-84. doi: 10.1016/j.tige.2020.06.001.

Gastroenterology

May 2021
Understanding GI Twitter and its major contributors. Elfanagely Y et al. Gastroenterology. 2021 May;160(6):1917-21. doi: 10.1053/j.gastro.2021.01.232.

Long-term safety of fecal microbiota transplantation for recurrent Clostridioides difficile infection. Saha S et al. Gastroenterology. 2021 May;160(6):1961-9.e3. doi: 10.1053/j.gastro.2021.01.010.

How to incorporate health equity training into gastroenterology and hepatology fellowships. Lee-Allen J, Shah BJ. Gastroenterology. 2021 May;160(6):1924-8. doi: 10.1053/j.gastro.2021.03.018.

Functional dyspepsia and gastroparesis in tertiary care are interchangeable syndromes with common clinical and pathologic features. Pasricha PJ et al. Gastroenterology. 2021 May;160(6):2006-17. doi: 10.1053/j.gastro.2021.01.230.

June 2021
How to manage the large nonpedunculated colorectal polyp. Shahidi N, Bourke MJ. Gastroenterology. 2021 Jun;160(7):2239-43.e1. doi: 10.1053/j.gastro.2021.04.029.

Mortality, reoperation, and hospital stay within 90 days of primary and secondary antireflux surgery in a population-based multinational study. Yanes M et al. Gastroenterology. 2021 Jun;160(7):2283-90. doi: 10.1053/j.gastro.2021.02.022.

Endoscopic submucosal dissection in north america: A large prospective multicenter study. Draganov PV et al. Gastroenterology. 2021 Jun;160(7):2317-27.e2. doi: 10.1053/j.gastro.2021.02.036.

July 2021
Gluten degradation, pharmacokinetics, safety, and tolerability of TAK-062, an engineered enzyme to treat celiac disease. Pultz IG et al. Gastroenterology. 2021 Jul;161(1):81-93.e3. doi: 10.1053/j.gastro.2021.03.019.

Paternal exposure to immunosuppressive and/or biologic agents and birth outcomes in patients with immune-mediated inflammatory diseases. Meserve J et al. Gastroenterology. 2021 Jul;161(1):107-115.e3. doi: 10.1053/j.gastro.2021.03.020.

Ethnicity associations with food sensitization are mediated by gut microbiota development in the first year of life. Tun Hm et al. Gastroenterology. 2021 Jul;161(1):94-106. doi: 10.1053/j.gastro.2021.03.016.

How to incorporate bariatric training into your fellowship program. Jirapinyo P, Thompson CC. Gastroenterology. 2019 Jul;157(1):9-13. doi: 10.1053/j.gastro.2019.05.034.

CGH

May 2021
Intestinal failure: What all gastroenterologists should know. Jansson-Knodell CL et al. Clin Gastroenterol Hepatol. 2021 May;19(5):885-8. doi: 10.1016/j.cgh.2021.01.038.

When and how to use endoscopic tattooing in the colon: An international Delphi agreement. Medina-Prado L et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1038-50. doi: 10.1016/j.cgh.2021.01.024.

Five-year outcomes of endoscopic sleeve gastroplasty for the treatment of obesity. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2021 May;19(5):1051-57.e2. doi: 10.1016/j.cgh.2020.09.055.

June 2021
GA Clinical Practice Update on management of bleeding gastric varices: Expert review. Henry Z et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1098-107.e1. doi: 10.1016/j.cgh.2021.01.027.

Inter- and intra-individual variation, and limited prognostic utility, of serum alkaline phosphatase in a trial of patients with primary sclerosing cholangitis

Palak J. Trivedi PJ et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1248-57. doi: 10.1016/j.cgh.2020.07.032.

Low-fat, high-fiber diet reduces markers of inflammation and dysbiosis and improves quality of life in patients with ulcerative colitis. Julia Fritsch J et al. Clin Gastroenterol Hepatol. 2021 Jun;19(6):1189-99.e30. doi: 10.1016/j.cgh.2020.05.026.

July 2021
Scoping out a better parental leave policy for gastroenterology fellows. Wegermann K. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1307-9. doi: 10.1016/j.cgh.2021.01.040.

An impetus for change: How COVID-19 will transform the delivery of GI health care. Leiman DA et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1310-1313. doi: 10.1016/j.cgh.2021.03.042.

Untangling nonerosive reflux disease from functional heartburn. Patel D et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1314-26. doi: 10.1016/j.cgh.2020.03.057.
 

AGA Clinical Practice Update on chemoprevention for colorectal neoplasia: Expert review. Liang PS et al. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1327-36. doi: 10.1016/j.cgh.2021.02.014.
 

CMGH

Drug inhibition of SARS-CoV-2 replication in human pluripotent stem cell–derived intestinal organoids. Krüger J et al. Cell Mol Gastroenterol Hepatol. 2021;11(4):935-48. doi: 10.1016/j.jcmgh.2020.11.003.
 

TIGE

Virtual interviews during the COVID-19 Pandemic: A survey of advanced endoscopy fellowship applicants and programs. Amrit K. Kamboj AK et al. Tech Innov Gastrointest Endosc. 2021;23(2):159-68. doi: 10.1016/j.tige.2021.02.001.

Triage of general gastrointestinal endoscopic procedures during the COVID-19 pandemic: Results from a national Delphi consensus panel. Feuerstein JD et al. Tech Innov Gastrointest Endosc. 2021;23(2):113-21. doi: 10.1016/j.tige.2020.12.005.

Development of a scoring system to predict a positive diagnosis on video capsule endoscopy for suspected small bowel bleeding. Marya NB et al. Tech Innov Gastrointest Endosc. 2021;22(4):178-84. doi: 10.1016/j.tige.2020.06.001.

With two sets of Clostridioides difficile recommendations being published within a month of each other, clinicians may find themselves trying to reconcile some of the conflicts between the two guidelines.

The first set, published June 1 by the American College of Gastroenterology, focuses on fecal microbiota transplantation (FMT) and the antibiotic vancomycin. The second, published June 24 by the Infectious Diseases Society of America and Society for Healthcare Epidemiology of America, drives a shift in treatment for initial episodes and short-term recurrence from vancomycin to fidaxomicin and, in some cases, adding on the monoclonal antibody bezlotoxumab, both made by Merck.

The updates are timely because researchers are now recognizing that C. difficile can colonize people without causing symptoms, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, said in an interview. He was not involved in writing either set of guidelines. “C. diff infection was a hospital-type infection, but we’re now seeing it in up to approximately 35%-50% of patients coming from the community, so it’s a big concern.”

Although the guidelines agree on which treatments are effective, the recommendations give the options a different emphasis.

Infectious disease specialist Stuart Johnson, MD, professor of medicine at Loyola University Medical Center in Maywood, Ill., and a physician researcher at Edward Hines Jr. Veterans Affairs Hospital in Hines, Ill., is the first author in the IDSA/SHEA guidelines. He told this news organization that one reason the two sets of recommendations may diverge in emphasis for initial and recurrent C. difficile is that “everyone has a different way of looking at things.” Compared with infectious disease specialists like him, he said, gastroenterologists “for the most part see the world a little different and have their own bent on things.” 

The differences between the two guidelines relate to the first-line therapy for people with an initial or recurrent C. difficile episode. For an initial episode, the IDSA/SHEA authors conditionally recommend fidaxomicin as first preferred choice over vancomycin, with a moderate certainty of evidence. They noted that implementing this recommendation depends on “available resources,” a reference to the higher cost and difficulty of access associated with fidaxomicin.

Gastroenterologist Monika Fischer, MD, an associate professor of medicine at Indiana University, Indianapolis, is one of the authors of the ACG guidelines. She told this news organization that the cost difference between fidaxomicin and vancomycin is considerable and finds the choice to foreground fidaxomicin puzzling. “They did not reference any new data compared to those we have published.” Their recommendation may make sense in terms of efficacy, but real-world demands require attention to cost and reimbursement. “They themselves state this in their recommendations,” she noted. 

Dr. Fischer cited a ballpark of about $100 for a course of vancomycin, compared with about $3,000 for a course of fidaxomicin. The IDSA/SHEA guidelines do cite vancomycin as an acceptable alternative. According to Dr. Fischer, the ACG guidelines authors discussed fidaxomicin and concluded that there just wasn’t enough evidence to justify favoring this antibiotic over vancomycin, given the cost-benefit imbalance. The ACG guidelines call for a standard course of oral vancomycin for a first, nonsevere C. difficile episode, listing oral fidaxomicin or oral metronidazole as alternatives.

For a recurrence, the IDSA/SHEA authors also favor fidaxomicin in a conditional recommendation over a standard course of vancomycin. For multiple recurrences, a tapered and pulsed vancomycin regimen, vancomycin followed by rifaximin, or FMT are also options.

Dr. David Johnson said that these recommendations favoring fidaxomicin are “surprising,” and that lower costs of vancomycin outweigh the benefit of fidaxomicin, given more-or-less comparable data on cure rates.

In contrast, the ACG guidelines recommend that an initial recurrence be treated with a tapering dose of vancomycin, and call for FMT for patients who are eligible and who experience a second or more C. difficile recurrences after a round of pulsed vancomycin.

Dr. Stuart Johnson said that FMT carries its own special set of issues. “If you don’t have a donor program set up, you have to rely on a stool bank,” noting that one widely used stool bank “basically had to stop making the product because of the coronavirus.” Costs for FMT products have doubled in recent years, and because Food and Drug Administration approval of the therapy is lacking, insurance does not cover it.

Dr. David Johnson also said that he is not “terribly happy” about the ACG recommendation for vancomycin prophylaxis. “It may help, but it also can have off-target effects against colonic bacterial flora, so we would not agree with that recommendation.”

The IDSA/SHEA authors also conditionally recommend bezlotoxumab, on very low certainty of evidence, as a cotherapy with standard of care antibiotics for recurrence prevention in patients with an episode in the last 6 months, particularly for patients at high recurrence risk “where logistics is not an issue.” The FDA has warned that this monoclonal antibody should be used with great care in patients with heart failure and only when benefits outweigh risks.

The ACG guidelines conditionally recommend considering bezlotoxumab to prevent recurrence in patients with specific risk factors, including age over 65 years and severe presentation. The IDSA/SHEA guidelines expand this population to anyone with a recurrence within 6 months, Dr. Fischer pointed out.

The antibody treatment “does offer another 10% absolute reduction in recurrent C. diff disease,” said Dr. Stuart Johnson, which is a “helpful option and primarily for people who have had recurrent C. diff already.” In general, he said, for both drugs, “access is still something we have to work with.”

In a commentary on the ACG guidelines, Dr. David Johnson wrote that there is good evidence that bezlotoxumab prevents relapse, especially in patients with specific risk factors. The hitch is the $4,500 price tag for a 1,000-mg vial, with a recommended dose of 10 mg/kg.

Dr. Stuart Johnson agreed that the costs of the fidaxomicin and bezlotoxumab are important considerations. In addition, there are logistical issues with using the antibody because most hospitals don’t offer infusions, which pushes patients to infusion centers.

Regardless, he added, “we’re happy that we have new options.”

Dr. Fischer, Dr. Stuart Johnson, and Dr. David Johnson reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

With two sets of Clostridioides difficile recommendations being published within a month of each other, clinicians may find themselves trying to reconcile some of the conflicts between the two guidelines.

The first set, published June 1 by the American College of Gastroenterology, focuses on fecal microbiota transplantation (FMT) and the antibiotic vancomycin. The second, published June 24 by the Infectious Diseases Society of America and Society for Healthcare Epidemiology of America, drives a shift in treatment for initial episodes and short-term recurrence from vancomycin to fidaxomicin and, in some cases, adding on the monoclonal antibody bezlotoxumab, both made by Merck.

The updates are timely because researchers are now recognizing that C. difficile can colonize people without causing symptoms, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, said in an interview. He was not involved in writing either set of guidelines. “C. diff infection was a hospital-type infection, but we’re now seeing it in up to approximately 35%-50% of patients coming from the community, so it’s a big concern.”

Although the guidelines agree on which treatments are effective, the recommendations give the options a different emphasis.

Infectious disease specialist Stuart Johnson, MD, professor of medicine at Loyola University Medical Center in Maywood, Ill., and a physician researcher at Edward Hines Jr. Veterans Affairs Hospital in Hines, Ill., is the first author in the IDSA/SHEA guidelines. He told this news organization that one reason the two sets of recommendations may diverge in emphasis for initial and recurrent C. difficile is that “everyone has a different way of looking at things.” Compared with infectious disease specialists like him, he said, gastroenterologists “for the most part see the world a little different and have their own bent on things.” 

The differences between the two guidelines relate to the first-line therapy for people with an initial or recurrent C. difficile episode. For an initial episode, the IDSA/SHEA authors conditionally recommend fidaxomicin as first preferred choice over vancomycin, with a moderate certainty of evidence. They noted that implementing this recommendation depends on “available resources,” a reference to the higher cost and difficulty of access associated with fidaxomicin.

Gastroenterologist Monika Fischer, MD, an associate professor of medicine at Indiana University, Indianapolis, is one of the authors of the ACG guidelines. She told this news organization that the cost difference between fidaxomicin and vancomycin is considerable and finds the choice to foreground fidaxomicin puzzling. “They did not reference any new data compared to those we have published.” Their recommendation may make sense in terms of efficacy, but real-world demands require attention to cost and reimbursement. “They themselves state this in their recommendations,” she noted. 

Dr. Fischer cited a ballpark of about $100 for a course of vancomycin, compared with about $3,000 for a course of fidaxomicin. The IDSA/SHEA guidelines do cite vancomycin as an acceptable alternative. According to Dr. Fischer, the ACG guidelines authors discussed fidaxomicin and concluded that there just wasn’t enough evidence to justify favoring this antibiotic over vancomycin, given the cost-benefit imbalance. The ACG guidelines call for a standard course of oral vancomycin for a first, nonsevere C. difficile episode, listing oral fidaxomicin or oral metronidazole as alternatives.

For a recurrence, the IDSA/SHEA authors also favor fidaxomicin in a conditional recommendation over a standard course of vancomycin. For multiple recurrences, a tapered and pulsed vancomycin regimen, vancomycin followed by rifaximin, or FMT are also options.

Dr. David Johnson said that these recommendations favoring fidaxomicin are “surprising,” and that lower costs of vancomycin outweigh the benefit of fidaxomicin, given more-or-less comparable data on cure rates.

In contrast, the ACG guidelines recommend that an initial recurrence be treated with a tapering dose of vancomycin, and call for FMT for patients who are eligible and who experience a second or more C. difficile recurrences after a round of pulsed vancomycin.

Dr. Stuart Johnson said that FMT carries its own special set of issues. “If you don’t have a donor program set up, you have to rely on a stool bank,” noting that one widely used stool bank “basically had to stop making the product because of the coronavirus.” Costs for FMT products have doubled in recent years, and because Food and Drug Administration approval of the therapy is lacking, insurance does not cover it.

Dr. David Johnson also said that he is not “terribly happy” about the ACG recommendation for vancomycin prophylaxis. “It may help, but it also can have off-target effects against colonic bacterial flora, so we would not agree with that recommendation.”

The IDSA/SHEA authors also conditionally recommend bezlotoxumab, on very low certainty of evidence, as a cotherapy with standard of care antibiotics for recurrence prevention in patients with an episode in the last 6 months, particularly for patients at high recurrence risk “where logistics is not an issue.” The FDA has warned that this monoclonal antibody should be used with great care in patients with heart failure and only when benefits outweigh risks.

The ACG guidelines conditionally recommend considering bezlotoxumab to prevent recurrence in patients with specific risk factors, including age over 65 years and severe presentation. The IDSA/SHEA guidelines expand this population to anyone with a recurrence within 6 months, Dr. Fischer pointed out.

The antibody treatment “does offer another 10% absolute reduction in recurrent C. diff disease,” said Dr. Stuart Johnson, which is a “helpful option and primarily for people who have had recurrent C. diff already.” In general, he said, for both drugs, “access is still something we have to work with.”

In a commentary on the ACG guidelines, Dr. David Johnson wrote that there is good evidence that bezlotoxumab prevents relapse, especially in patients with specific risk factors. The hitch is the $4,500 price tag for a 1,000-mg vial, with a recommended dose of 10 mg/kg.

Dr. Stuart Johnson agreed that the costs of the fidaxomicin and bezlotoxumab are important considerations. In addition, there are logistical issues with using the antibody because most hospitals don’t offer infusions, which pushes patients to infusion centers.

Regardless, he added, “we’re happy that we have new options.”

Dr. Fischer, Dr. Stuart Johnson, and Dr. David Johnson reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

With two sets of Clostridioides difficile recommendations being published within a month of each other, clinicians may find themselves trying to reconcile some of the conflicts between the two guidelines.

The first set, published June 1 by the American College of Gastroenterology, focuses on fecal microbiota transplantation (FMT) and the antibiotic vancomycin. The second, published June 24 by the Infectious Diseases Society of America and Society for Healthcare Epidemiology of America, drives a shift in treatment for initial episodes and short-term recurrence from vancomycin to fidaxomicin and, in some cases, adding on the monoclonal antibody bezlotoxumab, both made by Merck.

The updates are timely because researchers are now recognizing that C. difficile can colonize people without causing symptoms, David Johnson, MD, professor of medicine and chief of gastroenterology at the Eastern Virginia School of Medicine, Norfolk, said in an interview. He was not involved in writing either set of guidelines. “C. diff infection was a hospital-type infection, but we’re now seeing it in up to approximately 35%-50% of patients coming from the community, so it’s a big concern.”

Although the guidelines agree on which treatments are effective, the recommendations give the options a different emphasis.

Infectious disease specialist Stuart Johnson, MD, professor of medicine at Loyola University Medical Center in Maywood, Ill., and a physician researcher at Edward Hines Jr. Veterans Affairs Hospital in Hines, Ill., is the first author in the IDSA/SHEA guidelines. He told this news organization that one reason the two sets of recommendations may diverge in emphasis for initial and recurrent C. difficile is that “everyone has a different way of looking at things.” Compared with infectious disease specialists like him, he said, gastroenterologists “for the most part see the world a little different and have their own bent on things.” 

The differences between the two guidelines relate to the first-line therapy for people with an initial or recurrent C. difficile episode. For an initial episode, the IDSA/SHEA authors conditionally recommend fidaxomicin as first preferred choice over vancomycin, with a moderate certainty of evidence. They noted that implementing this recommendation depends on “available resources,” a reference to the higher cost and difficulty of access associated with fidaxomicin.

Gastroenterologist Monika Fischer, MD, an associate professor of medicine at Indiana University, Indianapolis, is one of the authors of the ACG guidelines. She told this news organization that the cost difference between fidaxomicin and vancomycin is considerable and finds the choice to foreground fidaxomicin puzzling. “They did not reference any new data compared to those we have published.” Their recommendation may make sense in terms of efficacy, but real-world demands require attention to cost and reimbursement. “They themselves state this in their recommendations,” she noted. 

Dr. Fischer cited a ballpark of about $100 for a course of vancomycin, compared with about $3,000 for a course of fidaxomicin. The IDSA/SHEA guidelines do cite vancomycin as an acceptable alternative. According to Dr. Fischer, the ACG guidelines authors discussed fidaxomicin and concluded that there just wasn’t enough evidence to justify favoring this antibiotic over vancomycin, given the cost-benefit imbalance. The ACG guidelines call for a standard course of oral vancomycin for a first, nonsevere C. difficile episode, listing oral fidaxomicin or oral metronidazole as alternatives.

For a recurrence, the IDSA/SHEA authors also favor fidaxomicin in a conditional recommendation over a standard course of vancomycin. For multiple recurrences, a tapered and pulsed vancomycin regimen, vancomycin followed by rifaximin, or FMT are also options.

Dr. David Johnson said that these recommendations favoring fidaxomicin are “surprising,” and that lower costs of vancomycin outweigh the benefit of fidaxomicin, given more-or-less comparable data on cure rates.

In contrast, the ACG guidelines recommend that an initial recurrence be treated with a tapering dose of vancomycin, and call for FMT for patients who are eligible and who experience a second or more C. difficile recurrences after a round of pulsed vancomycin.

Dr. Stuart Johnson said that FMT carries its own special set of issues. “If you don’t have a donor program set up, you have to rely on a stool bank,” noting that one widely used stool bank “basically had to stop making the product because of the coronavirus.” Costs for FMT products have doubled in recent years, and because Food and Drug Administration approval of the therapy is lacking, insurance does not cover it.

Dr. David Johnson also said that he is not “terribly happy” about the ACG recommendation for vancomycin prophylaxis. “It may help, but it also can have off-target effects against colonic bacterial flora, so we would not agree with that recommendation.”

The IDSA/SHEA authors also conditionally recommend bezlotoxumab, on very low certainty of evidence, as a cotherapy with standard of care antibiotics for recurrence prevention in patients with an episode in the last 6 months, particularly for patients at high recurrence risk “where logistics is not an issue.” The FDA has warned that this monoclonal antibody should be used with great care in patients with heart failure and only when benefits outweigh risks.

The ACG guidelines conditionally recommend considering bezlotoxumab to prevent recurrence in patients with specific risk factors, including age over 65 years and severe presentation. The IDSA/SHEA guidelines expand this population to anyone with a recurrence within 6 months, Dr. Fischer pointed out.

The antibody treatment “does offer another 10% absolute reduction in recurrent C. diff disease,” said Dr. Stuart Johnson, which is a “helpful option and primarily for people who have had recurrent C. diff already.” In general, he said, for both drugs, “access is still something we have to work with.”

In a commentary on the ACG guidelines, Dr. David Johnson wrote that there is good evidence that bezlotoxumab prevents relapse, especially in patients with specific risk factors. The hitch is the $4,500 price tag for a 1,000-mg vial, with a recommended dose of 10 mg/kg.

Dr. Stuart Johnson agreed that the costs of the fidaxomicin and bezlotoxumab are important considerations. In addition, there are logistical issues with using the antibody because most hospitals don’t offer infusions, which pushes patients to infusion centers.

Regardless, he added, “we’re happy that we have new options.”

Dr. Fischer, Dr. Stuart Johnson, and Dr. David Johnson reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Abnormal uterine bleeding (AUB) continues to be a top-10 reason why women present for gynecologic care, which makes keeping up with clinical therapies important. Over the past year, we have learned a tremendous amount about elagolix with hormonal add-back therapy for the treatment of bleeding associated with uterine fibroids. In this Update, we provide an overview from 3 randomized clinical trials on the recent US Food and Drug Administration (FDA)-approved drug, elagolix with hormonal add-back therapy (approved May 29, 2020). In addition, we review the data on the Cerene cryotherapy device (Channel Medsystems), as one might rightly ask, do we need another endometrial ablation device? We will address that question, as this device has some unique features that gynecologists should be aware of. Last, we review a study on the importance of considering quality of life in patients with uterine fibroids, which provides sobering information on the psychosocial aspects of uterine fibroids that all clinicians who care for such patients should be aware of.

Endometrial ablation with a new cryotherapy device: Is less more?

Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28:899-908.

The phrase “less is more,” in the world of architecture and design, is often associated with Ludwig Mies van der Rohe (1886–1969). One could argue that this principle is one key advantage with the addition of yet another non-resectoscopic endometrial ablation device. The Cerene cryotherapy device, FDA approved in 2019, is presented as a simple, disposable device for in-office use that takes advantage of natural cryoanesthesia and results in less tissue destruction than many other ablation methods.

Device reduces bleeding and permits greater ability for future evaluation

Recently, Curlin and colleagues conducted a prospective, multicenter clinical trial to evaluate the safety and efficacy of the Cerene device in reducing menstrual blood loss.¹ They followed 230 patients over 12 months and found that 81% (77% with intention-to-treat analysis) met the primary end point of a pictorial blood loss assessment chart (PBLAC) score of 75 or lower. Clinically, this translated to 44% of patients experiencing light bleeding; 27%, eumenorrhea; and 10%, amenorrhea. This is clearly “less” in terms of the rate of amenorrhea in most endometrial ablation studies. However, this also may translate into “more” ability to evaluate the endometrial cavity in the future, as 97% of the patients were able to undergo hysteroscopy at the 12-month mark and, of those, 93% were able to have the entire endometrial cavity assessed.

Further, of 97 patients who had a tubal sterilization, none had symptoms or evidence of postablation tubal sterilization syndrome. Three patients were unable to undergo hysteroscopy due to pain intolerance (2) or cervical stenosis (1). This is important because some gynecologists have expressed concern over intrauterine synechiae, which may result in scarring and associated future difficulty in assessing the endometrium for possible cancer.

Details about the device

The Cerene device is a single use, disposable device that uses cryothermal energy from nitrous oxide that results in a liquid-to-gas phase change within a polyurethane balloon (resulting in a temperature of -86°C) and delivered through a 6-mm sheath. It may be used in uterine cavities that measure between 2.5 and 6.5 cm in length, corresponding to approximately 10 cm in a uterine sound measurement. Treatment time is 2.5 minutes of nitrous oxide flow.

As mentioned, another benefit claimed is that the Cerene device’s cryoanalgesia properties enable the procedure to be more tolerated in the office setting. Of the 230 patients studied in the Curlin trial, no procedures were performed under general anesthesia.¹ Medications used included paracervical block (PCB) only (8%), PCB plus nonsteroidal anti-inflammatory drugs (19.8%), PCB plus oral narcotics/anxiolytics (69%), and PCB plus intravenous sedation (2.9%), showing that this device is ideally suited for in-office use.

The rate of serious adverse events was 2.5% (7 total events in 6 patients within 12 months). All serious adverse events were reviewed by a Clinical Events Committee and none were deemed to be device-related events.

Long-term outcomes remain to be seen

For physicians and patients who worry about the ability to access the endometrial cavity in the future, less may be more. It will be interesting to see what the long-term outcomes show with use of the Cerene cryotherapy device, and whether a lower amenorrhea rate will translate into a higher repeat intervention rate or not. Of course, not all are minimalists. As the architect Robert Venturi (1925–2018) was quoted as saying, “Less is a bore.”

Continue to: QoL assessment in women with fibroids is useful in evaluating treatment success...

QoL assessment in women with fibroids is useful in evaluating treatment success

Go VAA, Thomas MC, Singh B, et al. A systematic review of the psychosocial impact of fibroids before and after treatment. Am J Obstet Gynecol. 2020;223:674- 708.e8.

In many studies that assess AUB, the primary emphasis generally is placed on quantitation of menstrual bleeding by using PBLAC and alkaline hematin scores. In a systematic review, Go and colleagues argue the case for the importance of measuring the psychosocial impact of abnormal bleeding, emphasizing the concerning finding that many women with fibroids report lower vitality and lower social function scores than women with breast cancer.²

Fibroids associated with inconvenience—and anxiety

The authors analyzed and reviewed 18 randomized trials and 39 observational studies after screening 3,625 records from electronic database searches, with the goal to include only studies with validated quality of life (QoL) questionnaires that were administered both before and after treatment. A highlighted aspect of the reviewed studies was that “control” and “concern” subscales were most affected by fibroids, noting the inconvenience and anxiety that are related to the unpredictable onset and intensity of menses and the feeling of loss of control over one’s health and future.

This systematic review is important because although previous research has shown that fibroids significantly affect QoL, the psychosocial burden of fibroid symptoms had not been compared across different QoL instruments for both disease-specific and general validated health subscales.

Disability levels with fibroids are similar to those with other chronic diseases

Go and colleagues further reported that uterine fibroids have considerable psychosocial impact and lead to poor overall QoL physically and emotionally, with diminished sexual function and increased urinary or defecatory issues. Women with fibroids experienced a level of disability that was similar to that seen in other chronic diseases, and their vitality scores were lower than those associated with heart disease, diabetes, and as mentioned, breast cancer.

The authors concluded that “although objective clinical measures are important to establish a comprehensive understanding of health status, patient reported QoL outcomes play a critical role in evaluating success of a therapy.” They suggested that a larger emphasis on patient-centered care may help to mitigate the psychosocial effects of fibroids.

Continue to: What have we learned over the past year about elagolix for uterine fibroids?...

What have we learned over the past year about elagolix for uterine fibroids?

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.

Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021:224-72.e1-72.e50.

Data from the Elaris UF-1 and UF-2 6-month, phase 3 trials³ and the results of the Elaris UF-EXTEND trial with a 6-month extension (totaling 12 months of use)⁴ were published in 2020, and the 12-month results were discussed in OBG Management (2020;32[7]:35, 39-40). An additional data analysis from the same researchers assessed the effect of elagolix with hormonal add-back therapy in a number of patient subgroups.⁵ These 3 publications have added to our knowledge of this therapy, and it is worth reviewing them in this context

Design of the elagolix plus hormonal add-back therapy trials

The initial UF-1 and UF-2 trials were 2 identical, double-blind, randomized, placebo-controlled, 6-month, phase 3 trials designed to evaluate the safety and efficacy of elagolix and hormonal add-back therapy.³ UF-1 was conducted at 76 sites in the United States from December 2015 through December 2018, whereas UF-2 was conducted at 77 sites in the United States and Canada from February 2016 through January 2019; the trials were registered separately. Both trials had a 2:1:1 randomization of elagolix (300 mg twice daily) with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg daily), elagolix alone (300 mg twice daily), or placebo.

In the 6-month studies, the primary end point was both menstrual blood loss of less than 80 mL and at least a 50% reduction of menstrual blood loss as measured by the alkaline hematin method.³ Among several secondary end points was the assessment of QoL using the Uterine Fibroid Symptom QoL questionnaire (UFS-QoL).

Trial results. In UF-1, 68.5% of 206 women, and in UF-2, 76.5% of 189 women, respectively, taking elagolix with add-back therapy met the primary objective. Among women taking elagolix alone, in UF-1, 84.1% of 104 women, and in UF-2, 77% of 95 women, respectively, met criteria. There was improvement in UFS-QoL scores in women receiving elagolix plus add-back therapy with a reduction of symptom severity of -33.2 in UF-1 and -41.4 in UF-2, as compared with the placebo-treated groups (-10.3 and -7.7, respectively).

Adverse effects. Elagolix was associated with a low incidence of serious adverse effects, and the addition of hormonal add-back therapy attenuated the decreases in bone mineral density observed with elagolix alone. In both UF-1 and UF-2 trials, bone mineral density did not differ significantly in the groups of women who received elagolix with hormonal addback therapy versus placebo.

The extension trial results

Of note, in the 12-month study (6-month extension), the authors reported that 87.9% of the women taking elagolix with hormonal add-back therapy met the primary objective.4 Among the women taking elagolix alone, 89.4% met the primary objective.

In a review of the AbbVie-funded extension study, the editorial comments in the Obstetrical and Gynecological Survey expressed concern over the high proportion of data loss, comparing the number of patients joining the extended trial, patients who completed an additional 6 months of treatment, and patients who completed the posttreatment follow-up period of “up to 12 months.”⁶ Approximately one-third of patients were lost between initial enrollment to the subset who completed follow-up. There was concern that “losses of that magnitude pose a serious threat to validity.”⁶

Effectiveness in subgroups

Al-Hendy and colleagues analyzed data from the Elaris UF-1 and UF-2 trials to see if the outcomes for elagolix with hormonal addback therapy demonstrated safety and efficacy in subgroups of patients of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume.⁵

Results. In all subgroups, they found a statistically significant reduction in blood loss in mean menstrual blood loss volume for those treated with elagolix plus hormonal addback therapy compared with those treated with placebo. As well, in terms of QoL, among all subgroups, the mean change in symptom severity score as well as health-related QoL total score from baseline to month 6 was statistically significantly greater than the mean change in the placebo group.

The bottom line

Elagolix with hormonal add-back therapy appears to be a safe and effective method to reduce menstrual blood loss associated with uterine fibroids. It also has a favorable effect on QoL and appears to have benefits in subgroups of women of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume. ●

Abnormal uterine bleeding (AUB) continues to be a top-10 reason why women present for gynecologic care, which makes keeping up with clinical therapies important. Over the past year, we have learned a tremendous amount about elagolix with hormonal add-back therapy for the treatment of bleeding associated with uterine fibroids. In this Update, we provide an overview from 3 randomized clinical trials on the recent US Food and Drug Administration (FDA)-approved drug, elagolix with hormonal add-back therapy (approved May 29, 2020). In addition, we review the data on the Cerene cryotherapy device (Channel Medsystems), as one might rightly ask, do we need another endometrial ablation device? We will address that question, as this device has some unique features that gynecologists should be aware of. Last, we review a study on the importance of considering quality of life in patients with uterine fibroids, which provides sobering information on the psychosocial aspects of uterine fibroids that all clinicians who care for such patients should be aware of.

Endometrial ablation with a new cryotherapy device: Is less more?

Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28:899-908.

The phrase “less is more,” in the world of architecture and design, is often associated with Ludwig Mies van der Rohe (1886–1969). One could argue that this principle is one key advantage with the addition of yet another non-resectoscopic endometrial ablation device. The Cerene cryotherapy device, FDA approved in 2019, is presented as a simple, disposable device for in-office use that takes advantage of natural cryoanesthesia and results in less tissue destruction than many other ablation methods.

Device reduces bleeding and permits greater ability for future evaluation

Recently, Curlin and colleagues conducted a prospective, multicenter clinical trial to evaluate the safety and efficacy of the Cerene device in reducing menstrual blood loss.¹ They followed 230 patients over 12 months and found that 81% (77% with intention-to-treat analysis) met the primary end point of a pictorial blood loss assessment chart (PBLAC) score of 75 or lower. Clinically, this translated to 44% of patients experiencing light bleeding; 27%, eumenorrhea; and 10%, amenorrhea. This is clearly “less” in terms of the rate of amenorrhea in most endometrial ablation studies. However, this also may translate into “more” ability to evaluate the endometrial cavity in the future, as 97% of the patients were able to undergo hysteroscopy at the 12-month mark and, of those, 93% were able to have the entire endometrial cavity assessed.

Further, of 97 patients who had a tubal sterilization, none had symptoms or evidence of postablation tubal sterilization syndrome. Three patients were unable to undergo hysteroscopy due to pain intolerance (2) or cervical stenosis (1). This is important because some gynecologists have expressed concern over intrauterine synechiae, which may result in scarring and associated future difficulty in assessing the endometrium for possible cancer.

Details about the device

The Cerene device is a single use, disposable device that uses cryothermal energy from nitrous oxide that results in a liquid-to-gas phase change within a polyurethane balloon (resulting in a temperature of -86°C) and delivered through a 6-mm sheath. It may be used in uterine cavities that measure between 2.5 and 6.5 cm in length, corresponding to approximately 10 cm in a uterine sound measurement. Treatment time is 2.5 minutes of nitrous oxide flow.

As mentioned, another benefit claimed is that the Cerene device’s cryoanalgesia properties enable the procedure to be more tolerated in the office setting. Of the 230 patients studied in the Curlin trial, no procedures were performed under general anesthesia.¹ Medications used included paracervical block (PCB) only (8%), PCB plus nonsteroidal anti-inflammatory drugs (19.8%), PCB plus oral narcotics/anxiolytics (69%), and PCB plus intravenous sedation (2.9%), showing that this device is ideally suited for in-office use.

The rate of serious adverse events was 2.5% (7 total events in 6 patients within 12 months). All serious adverse events were reviewed by a Clinical Events Committee and none were deemed to be device-related events.

Long-term outcomes remain to be seen

For physicians and patients who worry about the ability to access the endometrial cavity in the future, less may be more. It will be interesting to see what the long-term outcomes show with use of the Cerene cryotherapy device, and whether a lower amenorrhea rate will translate into a higher repeat intervention rate or not. Of course, not all are minimalists. As the architect Robert Venturi (1925–2018) was quoted as saying, “Less is a bore.”

Continue to: QoL assessment in women with fibroids is useful in evaluating treatment success...

QoL assessment in women with fibroids is useful in evaluating treatment success

Go VAA, Thomas MC, Singh B, et al. A systematic review of the psychosocial impact of fibroids before and after treatment. Am J Obstet Gynecol. 2020;223:674- 708.e8.

In many studies that assess AUB, the primary emphasis generally is placed on quantitation of menstrual bleeding by using PBLAC and alkaline hematin scores. In a systematic review, Go and colleagues argue the case for the importance of measuring the psychosocial impact of abnormal bleeding, emphasizing the concerning finding that many women with fibroids report lower vitality and lower social function scores than women with breast cancer.²

Fibroids associated with inconvenience—and anxiety

The authors analyzed and reviewed 18 randomized trials and 39 observational studies after screening 3,625 records from electronic database searches, with the goal to include only studies with validated quality of life (QoL) questionnaires that were administered both before and after treatment. A highlighted aspect of the reviewed studies was that “control” and “concern” subscales were most affected by fibroids, noting the inconvenience and anxiety that are related to the unpredictable onset and intensity of menses and the feeling of loss of control over one’s health and future.

This systematic review is important because although previous research has shown that fibroids significantly affect QoL, the psychosocial burden of fibroid symptoms had not been compared across different QoL instruments for both disease-specific and general validated health subscales.

Disability levels with fibroids are similar to those with other chronic diseases

Go and colleagues further reported that uterine fibroids have considerable psychosocial impact and lead to poor overall QoL physically and emotionally, with diminished sexual function and increased urinary or defecatory issues. Women with fibroids experienced a level of disability that was similar to that seen in other chronic diseases, and their vitality scores were lower than those associated with heart disease, diabetes, and as mentioned, breast cancer.

The authors concluded that “although objective clinical measures are important to establish a comprehensive understanding of health status, patient reported QoL outcomes play a critical role in evaluating success of a therapy.” They suggested that a larger emphasis on patient-centered care may help to mitigate the psychosocial effects of fibroids.

Continue to: What have we learned over the past year about elagolix for uterine fibroids?...

What have we learned over the past year about elagolix for uterine fibroids?

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.

Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021:224-72.e1-72.e50.

Data from the Elaris UF-1 and UF-2 6-month, phase 3 trials³ and the results of the Elaris UF-EXTEND trial with a 6-month extension (totaling 12 months of use)⁴ were published in 2020, and the 12-month results were discussed in OBG Management (2020;32[7]:35, 39-40). An additional data analysis from the same researchers assessed the effect of elagolix with hormonal add-back therapy in a number of patient subgroups.⁵ These 3 publications have added to our knowledge of this therapy, and it is worth reviewing them in this context

Design of the elagolix plus hormonal add-back therapy trials

The initial UF-1 and UF-2 trials were 2 identical, double-blind, randomized, placebo-controlled, 6-month, phase 3 trials designed to evaluate the safety and efficacy of elagolix and hormonal add-back therapy.³ UF-1 was conducted at 76 sites in the United States from December 2015 through December 2018, whereas UF-2 was conducted at 77 sites in the United States and Canada from February 2016 through January 2019; the trials were registered separately. Both trials had a 2:1:1 randomization of elagolix (300 mg twice daily) with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg daily), elagolix alone (300 mg twice daily), or placebo.

In the 6-month studies, the primary end point was both menstrual blood loss of less than 80 mL and at least a 50% reduction of menstrual blood loss as measured by the alkaline hematin method.³ Among several secondary end points was the assessment of QoL using the Uterine Fibroid Symptom QoL questionnaire (UFS-QoL).

Trial results. In UF-1, 68.5% of 206 women, and in UF-2, 76.5% of 189 women, respectively, taking elagolix with add-back therapy met the primary objective. Among women taking elagolix alone, in UF-1, 84.1% of 104 women, and in UF-2, 77% of 95 women, respectively, met criteria. There was improvement in UFS-QoL scores in women receiving elagolix plus add-back therapy with a reduction of symptom severity of -33.2 in UF-1 and -41.4 in UF-2, as compared with the placebo-treated groups (-10.3 and -7.7, respectively).

Adverse effects. Elagolix was associated with a low incidence of serious adverse effects, and the addition of hormonal add-back therapy attenuated the decreases in bone mineral density observed with elagolix alone. In both UF-1 and UF-2 trials, bone mineral density did not differ significantly in the groups of women who received elagolix with hormonal addback therapy versus placebo.

The extension trial results

Of note, in the 12-month study (6-month extension), the authors reported that 87.9% of the women taking elagolix with hormonal add-back therapy met the primary objective.4 Among the women taking elagolix alone, 89.4% met the primary objective.

In a review of the AbbVie-funded extension study, the editorial comments in the Obstetrical and Gynecological Survey expressed concern over the high proportion of data loss, comparing the number of patients joining the extended trial, patients who completed an additional 6 months of treatment, and patients who completed the posttreatment follow-up period of “up to 12 months.”⁶ Approximately one-third of patients were lost between initial enrollment to the subset who completed follow-up. There was concern that “losses of that magnitude pose a serious threat to validity.”⁶

Effectiveness in subgroups

Al-Hendy and colleagues analyzed data from the Elaris UF-1 and UF-2 trials to see if the outcomes for elagolix with hormonal addback therapy demonstrated safety and efficacy in subgroups of patients of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume.⁵

Results. In all subgroups, they found a statistically significant reduction in blood loss in mean menstrual blood loss volume for those treated with elagolix plus hormonal addback therapy compared with those treated with placebo. As well, in terms of QoL, among all subgroups, the mean change in symptom severity score as well as health-related QoL total score from baseline to month 6 was statistically significantly greater than the mean change in the placebo group.

The bottom line

Elagolix with hormonal add-back therapy appears to be a safe and effective method to reduce menstrual blood loss associated with uterine fibroids. It also has a favorable effect on QoL and appears to have benefits in subgroups of women of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume. ●

Abnormal uterine bleeding (AUB) continues to be a top-10 reason why women present for gynecologic care, which makes keeping up with clinical therapies important. Over the past year, we have learned a tremendous amount about elagolix with hormonal add-back therapy for the treatment of bleeding associated with uterine fibroids. In this Update, we provide an overview from 3 randomized clinical trials on the recent US Food and Drug Administration (FDA)-approved drug, elagolix with hormonal add-back therapy (approved May 29, 2020). In addition, we review the data on the Cerene cryotherapy device (Channel Medsystems), as one might rightly ask, do we need another endometrial ablation device? We will address that question, as this device has some unique features that gynecologists should be aware of. Last, we review a study on the importance of considering quality of life in patients with uterine fibroids, which provides sobering information on the psychosocial aspects of uterine fibroids that all clinicians who care for such patients should be aware of.

Endometrial ablation with a new cryotherapy device: Is less more?

Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28:899-908.

The phrase “less is more,” in the world of architecture and design, is often associated with Ludwig Mies van der Rohe (1886–1969). One could argue that this principle is one key advantage with the addition of yet another non-resectoscopic endometrial ablation device. The Cerene cryotherapy device, FDA approved in 2019, is presented as a simple, disposable device for in-office use that takes advantage of natural cryoanesthesia and results in less tissue destruction than many other ablation methods.

Device reduces bleeding and permits greater ability for future evaluation

Recently, Curlin and colleagues conducted a prospective, multicenter clinical trial to evaluate the safety and efficacy of the Cerene device in reducing menstrual blood loss.¹ They followed 230 patients over 12 months and found that 81% (77% with intention-to-treat analysis) met the primary end point of a pictorial blood loss assessment chart (PBLAC) score of 75 or lower. Clinically, this translated to 44% of patients experiencing light bleeding; 27%, eumenorrhea; and 10%, amenorrhea. This is clearly “less” in terms of the rate of amenorrhea in most endometrial ablation studies. However, this also may translate into “more” ability to evaluate the endometrial cavity in the future, as 97% of the patients were able to undergo hysteroscopy at the 12-month mark and, of those, 93% were able to have the entire endometrial cavity assessed.

Further, of 97 patients who had a tubal sterilization, none had symptoms or evidence of postablation tubal sterilization syndrome. Three patients were unable to undergo hysteroscopy due to pain intolerance (2) or cervical stenosis (1). This is important because some gynecologists have expressed concern over intrauterine synechiae, which may result in scarring and associated future difficulty in assessing the endometrium for possible cancer.

Details about the device

The Cerene device is a single use, disposable device that uses cryothermal energy from nitrous oxide that results in a liquid-to-gas phase change within a polyurethane balloon (resulting in a temperature of -86°C) and delivered through a 6-mm sheath. It may be used in uterine cavities that measure between 2.5 and 6.5 cm in length, corresponding to approximately 10 cm in a uterine sound measurement. Treatment time is 2.5 minutes of nitrous oxide flow.

As mentioned, another benefit claimed is that the Cerene device’s cryoanalgesia properties enable the procedure to be more tolerated in the office setting. Of the 230 patients studied in the Curlin trial, no procedures were performed under general anesthesia.¹ Medications used included paracervical block (PCB) only (8%), PCB plus nonsteroidal anti-inflammatory drugs (19.8%), PCB plus oral narcotics/anxiolytics (69%), and PCB plus intravenous sedation (2.9%), showing that this device is ideally suited for in-office use.

The rate of serious adverse events was 2.5% (7 total events in 6 patients within 12 months). All serious adverse events were reviewed by a Clinical Events Committee and none were deemed to be device-related events.

Long-term outcomes remain to be seen

For physicians and patients who worry about the ability to access the endometrial cavity in the future, less may be more. It will be interesting to see what the long-term outcomes show with use of the Cerene cryotherapy device, and whether a lower amenorrhea rate will translate into a higher repeat intervention rate or not. Of course, not all are minimalists. As the architect Robert Venturi (1925–2018) was quoted as saying, “Less is a bore.”

Continue to: QoL assessment in women with fibroids is useful in evaluating treatment success...

QoL assessment in women with fibroids is useful in evaluating treatment success

Go VAA, Thomas MC, Singh B, et al. A systematic review of the psychosocial impact of fibroids before and after treatment. Am J Obstet Gynecol. 2020;223:674- 708.e8.

In many studies that assess AUB, the primary emphasis generally is placed on quantitation of menstrual bleeding by using PBLAC and alkaline hematin scores. In a systematic review, Go and colleagues argue the case for the importance of measuring the psychosocial impact of abnormal bleeding, emphasizing the concerning finding that many women with fibroids report lower vitality and lower social function scores than women with breast cancer.²

Fibroids associated with inconvenience—and anxiety

The authors analyzed and reviewed 18 randomized trials and 39 observational studies after screening 3,625 records from electronic database searches, with the goal to include only studies with validated quality of life (QoL) questionnaires that were administered both before and after treatment. A highlighted aspect of the reviewed studies was that “control” and “concern” subscales were most affected by fibroids, noting the inconvenience and anxiety that are related to the unpredictable onset and intensity of menses and the feeling of loss of control over one’s health and future.

This systematic review is important because although previous research has shown that fibroids significantly affect QoL, the psychosocial burden of fibroid symptoms had not been compared across different QoL instruments for both disease-specific and general validated health subscales.

Disability levels with fibroids are similar to those with other chronic diseases

Go and colleagues further reported that uterine fibroids have considerable psychosocial impact and lead to poor overall QoL physically and emotionally, with diminished sexual function and increased urinary or defecatory issues. Women with fibroids experienced a level of disability that was similar to that seen in other chronic diseases, and their vitality scores were lower than those associated with heart disease, diabetes, and as mentioned, breast cancer.

The authors concluded that “although objective clinical measures are important to establish a comprehensive understanding of health status, patient reported QoL outcomes play a critical role in evaluating success of a therapy.” They suggested that a larger emphasis on patient-centered care may help to mitigate the psychosocial effects of fibroids.

Continue to: What have we learned over the past year about elagolix for uterine fibroids?...

What have we learned over the past year about elagolix for uterine fibroids?

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.

Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021:224-72.e1-72.e50.

Data from the Elaris UF-1 and UF-2 6-month, phase 3 trials³ and the results of the Elaris UF-EXTEND trial with a 6-month extension (totaling 12 months of use)⁴ were published in 2020, and the 12-month results were discussed in OBG Management (2020;32[7]:35, 39-40). An additional data analysis from the same researchers assessed the effect of elagolix with hormonal add-back therapy in a number of patient subgroups.⁵ These 3 publications have added to our knowledge of this therapy, and it is worth reviewing them in this context

Design of the elagolix plus hormonal add-back therapy trials

The initial UF-1 and UF-2 trials were 2 identical, double-blind, randomized, placebo-controlled, 6-month, phase 3 trials designed to evaluate the safety and efficacy of elagolix and hormonal add-back therapy.³ UF-1 was conducted at 76 sites in the United States from December 2015 through December 2018, whereas UF-2 was conducted at 77 sites in the United States and Canada from February 2016 through January 2019; the trials were registered separately. Both trials had a 2:1:1 randomization of elagolix (300 mg twice daily) with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg daily), elagolix alone (300 mg twice daily), or placebo.

In the 6-month studies, the primary end point was both menstrual blood loss of less than 80 mL and at least a 50% reduction of menstrual blood loss as measured by the alkaline hematin method.³ Among several secondary end points was the assessment of QoL using the Uterine Fibroid Symptom QoL questionnaire (UFS-QoL).

Trial results. In UF-1, 68.5% of 206 women, and in UF-2, 76.5% of 189 women, respectively, taking elagolix with add-back therapy met the primary objective. Among women taking elagolix alone, in UF-1, 84.1% of 104 women, and in UF-2, 77% of 95 women, respectively, met criteria. There was improvement in UFS-QoL scores in women receiving elagolix plus add-back therapy with a reduction of symptom severity of -33.2 in UF-1 and -41.4 in UF-2, as compared with the placebo-treated groups (-10.3 and -7.7, respectively).

Adverse effects. Elagolix was associated with a low incidence of serious adverse effects, and the addition of hormonal add-back therapy attenuated the decreases in bone mineral density observed with elagolix alone. In both UF-1 and UF-2 trials, bone mineral density did not differ significantly in the groups of women who received elagolix with hormonal addback therapy versus placebo.

The extension trial results

Of note, in the 12-month study (6-month extension), the authors reported that 87.9% of the women taking elagolix with hormonal add-back therapy met the primary objective.4 Among the women taking elagolix alone, 89.4% met the primary objective.

In a review of the AbbVie-funded extension study, the editorial comments in the Obstetrical and Gynecological Survey expressed concern over the high proportion of data loss, comparing the number of patients joining the extended trial, patients who completed an additional 6 months of treatment, and patients who completed the posttreatment follow-up period of “up to 12 months.”⁶ Approximately one-third of patients were lost between initial enrollment to the subset who completed follow-up. There was concern that “losses of that magnitude pose a serious threat to validity.”⁶

Effectiveness in subgroups

Al-Hendy and colleagues analyzed data from the Elaris UF-1 and UF-2 trials to see if the outcomes for elagolix with hormonal addback therapy demonstrated safety and efficacy in subgroups of patients of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume.⁵

Results. In all subgroups, they found a statistically significant reduction in blood loss in mean menstrual blood loss volume for those treated with elagolix plus hormonal addback therapy compared with those treated with placebo. As well, in terms of QoL, among all subgroups, the mean change in symptom severity score as well as health-related QoL total score from baseline to month 6 was statistically significantly greater than the mean change in the placebo group.

The bottom line

Elagolix with hormonal add-back therapy appears to be a safe and effective method to reduce menstrual blood loss associated with uterine fibroids. It also has a favorable effect on QoL and appears to have benefits in subgroups of women of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume. ●

Patient:

Alone in the Emergency Dept, breathless, I wait for you

“The Hospitalist will admit you” says the nurse, “she will come in a few.”

Muffled voices – masked faces bustle in & out of the room

Loud beeping machines & the rushed pace, fill me with gloom



You walk in the room, lean in to introduce

You tell me your name and what you will do

For a moment I’m more than a diagnosis, an H&P,

and then the fleeting connection passes, can’t you see?

You listen, seem hurried, but I think you care

Would you sit with me while my story I share?

Physician:

I do see you, I feel your fear & anguish

A moment to know you too, is all that I wish

How do I convince you that I truly care?

When, with all my tasks I have only minutes to spare

Patient:

You diligently ask questions from your checklist of H.P.I.,

Finalizing the diagnosis, when I hear your pager beep.

An admission awaits I know, but please sit by my side

Could we make our new-found meeting, a little more deep?

Physician:

The minute our day begins, it’s go-go-go

There isn’t a second to pause, inhale, or be slow

Missed lunch, it’s 6 p.m., bite to eat I dare?

My shift ended 3 hrs. back but I’m still here

Notes, DC summaries, calls to your PCP

Advocating for you, is more than a job to me.



Tirelessly I work, giving patients my all

Drained, exhausted yet, for you, standing tall

Our bond albeit short lived, is very important to me

Watching you get better each day, is fulfilling for me!

Patient:

You take time to ask about my family, about what I like to do

I tell you all about Beatles & my sweet grandkids

You sit & ask me “what matters most to you”

I reply: getting well for the wedding of my daughter “Sue”

Physician:

I sense loneliness engulfing you at times

Your fear and anxiety, I promise to help overcome

I will help you navigate this complex hospital stay

Together we will fight this virus or anything that comes our way

Each passing minute the line between doctor and patient disappears

That’s when we win over this virus, and hope replaces fear

Patient:

Every day you come see me, tell me my numbers are improving

I notice your warm and kind eyes behind that stifling mask

When they light up as you tell me I’m going home soon

I feel assured I mean more to you, than a mere task

Physician:

Each day I visit, together we hum “here comes the sun”

I too open up and share with you, my favorite Beatles song

Our visits cover much more than clinical medicine

True connection & mutual soul healing begins, before long.

Patient:

Today is the day, grateful to go home,

My body may be healed due to all the medicine & potions,

But my bruised soul was healed due to all your kind emotions.



Time to bid adieu Dear Doc – If I meet you at our local grocery store,

I promise I’ll remember those kind eyes, and wave

After all, you stood between me and death

I’m indebted to you, it’s my life that you did save!
 

Dr. Mehta is a hospitalist and director of quality and performance and patient experience at Vituity in Emeryville, Calif. She is chair of the SHM patient experience executive council and executive board member of the SHM San Francisco Bay Area chapter.
 

Patient:

Alone in the Emergency Dept, breathless, I wait for you

“The Hospitalist will admit you” says the nurse, “she will come in a few.”

Muffled voices – masked faces bustle in & out of the room

Loud beeping machines & the rushed pace, fill me with gloom



You walk in the room, lean in to introduce

You tell me your name and what you will do

For a moment I’m more than a diagnosis, an H&P,

and then the fleeting connection passes, can’t you see?

You listen, seem hurried, but I think you care

Would you sit with me while my story I share?

Physician:

I do see you, I feel your fear & anguish

A moment to know you too, is all that I wish

How do I convince you that I truly care?

When, with all my tasks I have only minutes to spare

Patient:

You diligently ask questions from your checklist of H.P.I.,

Finalizing the diagnosis, when I hear your pager beep.

An admission awaits I know, but please sit by my side

Could we make our new-found meeting, a little more deep?

Physician:

The minute our day begins, it’s go-go-go

There isn’t a second to pause, inhale, or be slow

Missed lunch, it’s 6 p.m., bite to eat I dare?

My shift ended 3 hrs. back but I’m still here

Notes, DC summaries, calls to your PCP

Advocating for you, is more than a job to me.



Tirelessly I work, giving patients my all

Drained, exhausted yet, for you, standing tall

Our bond albeit short lived, is very important to me

Watching you get better each day, is fulfilling for me!

Patient:

You take time to ask about my family, about what I like to do

I tell you all about Beatles & my sweet grandkids

You sit & ask me “what matters most to you”

I reply: getting well for the wedding of my daughter “Sue”

Physician:

I sense loneliness engulfing you at times

Your fear and anxiety, I promise to help overcome

I will help you navigate this complex hospital stay

Together we will fight this virus or anything that comes our way

Each passing minute the line between doctor and patient disappears

That’s when we win over this virus, and hope replaces fear

Patient:

Every day you come see me, tell me my numbers are improving

I notice your warm and kind eyes behind that stifling mask

When they light up as you tell me I’m going home soon

I feel assured I mean more to you, than a mere task

Physician:

Each day I visit, together we hum “here comes the sun”

I too open up and share with you, my favorite Beatles song

Our visits cover much more than clinical medicine

True connection & mutual soul healing begins, before long.

Patient:

Today is the day, grateful to go home,

My body may be healed due to all the medicine & potions,

But my bruised soul was healed due to all your kind emotions.



Time to bid adieu Dear Doc – If I meet you at our local grocery store,

I promise I’ll remember those kind eyes, and wave

After all, you stood between me and death

I’m indebted to you, it’s my life that you did save!
 

Dr. Mehta is a hospitalist and director of quality and performance and patient experience at Vituity in Emeryville, Calif. She is chair of the SHM patient experience executive council and executive board member of the SHM San Francisco Bay Area chapter.
 

Patient:

Alone in the Emergency Dept, breathless, I wait for you

“The Hospitalist will admit you” says the nurse, “she will come in a few.”

Muffled voices – masked faces bustle in & out of the room

Loud beeping machines & the rushed pace, fill me with gloom



You walk in the room, lean in to introduce

You tell me your name and what you will do

For a moment I’m more than a diagnosis, an H&P,

and then the fleeting connection passes, can’t you see?

You listen, seem hurried, but I think you care

Would you sit with me while my story I share?

Physician:

I do see you, I feel your fear & anguish

A moment to know you too, is all that I wish

How do I convince you that I truly care?

When, with all my tasks I have only minutes to spare

Patient:

You diligently ask questions from your checklist of H.P.I.,

Finalizing the diagnosis, when I hear your pager beep.

An admission awaits I know, but please sit by my side

Could we make our new-found meeting, a little more deep?

Physician:

The minute our day begins, it’s go-go-go

There isn’t a second to pause, inhale, or be slow

Missed lunch, it’s 6 p.m., bite to eat I dare?

My shift ended 3 hrs. back but I’m still here

Notes, DC summaries, calls to your PCP

Advocating for you, is more than a job to me.



Tirelessly I work, giving patients my all

Drained, exhausted yet, for you, standing tall

Our bond albeit short lived, is very important to me

Watching you get better each day, is fulfilling for me!

Patient:

You take time to ask about my family, about what I like to do

I tell you all about Beatles & my sweet grandkids

You sit & ask me “what matters most to you”

I reply: getting well for the wedding of my daughter “Sue”

Physician:

I sense loneliness engulfing you at times

Your fear and anxiety, I promise to help overcome

I will help you navigate this complex hospital stay

Together we will fight this virus or anything that comes our way

Each passing minute the line between doctor and patient disappears

That’s when we win over this virus, and hope replaces fear

Patient:

Every day you come see me, tell me my numbers are improving

I notice your warm and kind eyes behind that stifling mask

When they light up as you tell me I’m going home soon

I feel assured I mean more to you, than a mere task

Physician:

Each day I visit, together we hum “here comes the sun”

I too open up and share with you, my favorite Beatles song

Our visits cover much more than clinical medicine

True connection & mutual soul healing begins, before long.

Patient:

Today is the day, grateful to go home,

My body may be healed due to all the medicine & potions,

But my bruised soul was healed due to all your kind emotions.



Time to bid adieu Dear Doc – If I meet you at our local grocery store,

I promise I’ll remember those kind eyes, and wave

After all, you stood between me and death

I’m indebted to you, it’s my life that you did save!
 

Dr. Mehta is a hospitalist and director of quality and performance and patient experience at Vituity in Emeryville, Calif. She is chair of the SHM patient experience executive council and executive board member of the SHM San Francisco Bay Area chapter.
 

Violin and viola players can pay a price for the music they create: Many suffer from skin irritation and inflammation where the instruments touch their necks and upper bodies. Now, a new literature review offers insight into this common condition, known as “fiddler’s neck.”

Hill Street Studios/Stone/Getty Images

“These skin conditions are disfiguring, and they also carry so much psychological burden. Not only are these patients under constant pressure to perform at their maximum at all times, it really is troublesome when there is a barrier between you and performing art that you absolutely love,” lead author Henry Lim, an osteopathic medical student at the University of North Texas Health Science Center at Fort Worth, said in an interview.

The results of the literature review were presented in a poster at the Inaugural Symposium for Inflammatory Skin Disease.

Mr. Lim, who has a special interest in skin, said his own musical experience inspired the research. “Throughout my experience as a violinist, I faced many dermatologic issues because of my violin, and it affected my performance,” he said. “As time went on, I recognized that many other stringed instrumentalists were dealing with similar issues but chose to live with it because it came with the territory.”

One physician told Mr. Lim that he needed to quit in order to permanently treat his skin problems. He didn’t accept this answer and instead launched the literature review with colleagues Marshall Hall, MPH, also an osteopathic medical student with an interest in dermatology, and Sajid Surve, DO, codirector of the UNT Texas Center for Performing Arts Health.

Mr. Lim and colleagues evaluated 23 articles, which included case studies and literature reviews, about dermatitis in violinists, violists, cellists, bassists, guitarists and harpists. “Stringed instrumentalists are the highest at-risk population compared to performers who play other types of instruments,” Mr. Lim said.

The poster he presented at the meeting largely focuses on fiddler’s neck, which he defined as “simply dermatitis related to friction and allergic irritation from playing violin or viola.” Many people, he noted, are allergic to nickel, and the bracket that secures the violin’s chin rest “most often contains nickel. Even a very small concentration of nickel can cause massive reactions, and we found that the C string of a viola – the thickest, lowest-sounding string – contains a nickel concentration of up to 37%.”

Gold-coated strings are an alternative option, he said, but they’re more expensive.

Stringed instrumentalists may also be allergic to rosin applied to “bow hairs,” which is the hair – typically from horses – that is used to string bows, also described in the poster. “We found that there is an overall common allergy to the main ingredient called colophony,” Mr. Lim said. The legendary violin maker Antonio Stradivari “was rumored to have used colophony and another irritating ingredient called propolis in the wood varnish of his instruments. Because he was such a great influence on the art of violin crafting, his technique is still used in the modern era, which may be another contributing factor to the allergic reactions seen in stringed instrumentalists.”

(In the poster, the authors refer to one of the articles in the review, which described a violin maker allergic to colophony and propolis, who was treated with cetirizine, mild corticosteroids, and avoidance.)

What should dermatologists know about skin conditions in these musicians? Mr. Hall, one of the coauthors of the report, suggested they invite the patients to play their instruments during a visit. “The musicians may not understand that they are doing certain things with their movements, but looking from a clinical lens, we are able to see how their biomechanics and posture [are] contributing to their dermatitis,” he said.

Dr. Surve, the other coauthor, also suggested speaking to the patient’s teacher, coach, or mentor. “Keeping that person in the loop regarding what you are seeing and recommending will go a long way towards helping your patient,” he said. “If the teacher doesn’t understand or agree with what you’re trying to accomplish, they may try to undermine your plan of care. But if they are on board, they become a valuable tool for facilitating and reinforcing it.”

As for treatments, avoidance of the instruments is the most effective, but is simply not feasible for many musicians. “Certain interventions like creating a barrier between the musician and the instrument can reduce the risk of contact dermatitis without compromising the quality [of playing] as much,” Mr. Hall said. The poster reported that a handkerchief was used for this purpose in one case attributed to nickel sulfate in a 16-year-old .

Purchasing more expensive instrument materials to prevent reactions is another option, he said, and players can also purchase stands. But musicians may be resistant to any treatment that changes how the instruments sound or forces them to adjust the way they do things, he cautioned.

No funding for the study or author disclosures were reported.

Violin and viola players can pay a price for the music they create: Many suffer from skin irritation and inflammation where the instruments touch their necks and upper bodies. Now, a new literature review offers insight into this common condition, known as “fiddler’s neck.”

Hill Street Studios/Stone/Getty Images

“These skin conditions are disfiguring, and they also carry so much psychological burden. Not only are these patients under constant pressure to perform at their maximum at all times, it really is troublesome when there is a barrier between you and performing art that you absolutely love,” lead author Henry Lim, an osteopathic medical student at the University of North Texas Health Science Center at Fort Worth, said in an interview.

The results of the literature review were presented in a poster at the Inaugural Symposium for Inflammatory Skin Disease.

Mr. Lim, who has a special interest in skin, said his own musical experience inspired the research. “Throughout my experience as a violinist, I faced many dermatologic issues because of my violin, and it affected my performance,” he said. “As time went on, I recognized that many other stringed instrumentalists were dealing with similar issues but chose to live with it because it came with the territory.”

One physician told Mr. Lim that he needed to quit in order to permanently treat his skin problems. He didn’t accept this answer and instead launched the literature review with colleagues Marshall Hall, MPH, also an osteopathic medical student with an interest in dermatology, and Sajid Surve, DO, codirector of the UNT Texas Center for Performing Arts Health.

Mr. Lim and colleagues evaluated 23 articles, which included case studies and literature reviews, about dermatitis in violinists, violists, cellists, bassists, guitarists and harpists. “Stringed instrumentalists are the highest at-risk population compared to performers who play other types of instruments,” Mr. Lim said.

The poster he presented at the meeting largely focuses on fiddler’s neck, which he defined as “simply dermatitis related to friction and allergic irritation from playing violin or viola.” Many people, he noted, are allergic to nickel, and the bracket that secures the violin’s chin rest “most often contains nickel. Even a very small concentration of nickel can cause massive reactions, and we found that the C string of a viola – the thickest, lowest-sounding string – contains a nickel concentration of up to 37%.”

Gold-coated strings are an alternative option, he said, but they’re more expensive.

Stringed instrumentalists may also be allergic to rosin applied to “bow hairs,” which is the hair – typically from horses – that is used to string bows, also described in the poster. “We found that there is an overall common allergy to the main ingredient called colophony,” Mr. Lim said. The legendary violin maker Antonio Stradivari “was rumored to have used colophony and another irritating ingredient called propolis in the wood varnish of his instruments. Because he was such a great influence on the art of violin crafting, his technique is still used in the modern era, which may be another contributing factor to the allergic reactions seen in stringed instrumentalists.”

(In the poster, the authors refer to one of the articles in the review, which described a violin maker allergic to colophony and propolis, who was treated with cetirizine, mild corticosteroids, and avoidance.)

What should dermatologists know about skin conditions in these musicians? Mr. Hall, one of the coauthors of the report, suggested they invite the patients to play their instruments during a visit. “The musicians may not understand that they are doing certain things with their movements, but looking from a clinical lens, we are able to see how their biomechanics and posture [are] contributing to their dermatitis,” he said.

Dr. Surve, the other coauthor, also suggested speaking to the patient’s teacher, coach, or mentor. “Keeping that person in the loop regarding what you are seeing and recommending will go a long way towards helping your patient,” he said. “If the teacher doesn’t understand or agree with what you’re trying to accomplish, they may try to undermine your plan of care. But if they are on board, they become a valuable tool for facilitating and reinforcing it.”

As for treatments, avoidance of the instruments is the most effective, but is simply not feasible for many musicians. “Certain interventions like creating a barrier between the musician and the instrument can reduce the risk of contact dermatitis without compromising the quality [of playing] as much,” Mr. Hall said. The poster reported that a handkerchief was used for this purpose in one case attributed to nickel sulfate in a 16-year-old .

Purchasing more expensive instrument materials to prevent reactions is another option, he said, and players can also purchase stands. But musicians may be resistant to any treatment that changes how the instruments sound or forces them to adjust the way they do things, he cautioned.

No funding for the study or author disclosures were reported.

Violin and viola players can pay a price for the music they create: Many suffer from skin irritation and inflammation where the instruments touch their necks and upper bodies. Now, a new literature review offers insight into this common condition, known as “fiddler’s neck.”

Hill Street Studios/Stone/Getty Images

“These skin conditions are disfiguring, and they also carry so much psychological burden. Not only are these patients under constant pressure to perform at their maximum at all times, it really is troublesome when there is a barrier between you and performing art that you absolutely love,” lead author Henry Lim, an osteopathic medical student at the University of North Texas Health Science Center at Fort Worth, said in an interview.

The results of the literature review were presented in a poster at the Inaugural Symposium for Inflammatory Skin Disease.

Mr. Lim, who has a special interest in skin, said his own musical experience inspired the research. “Throughout my experience as a violinist, I faced many dermatologic issues because of my violin, and it affected my performance,” he said. “As time went on, I recognized that many other stringed instrumentalists were dealing with similar issues but chose to live with it because it came with the territory.”

One physician told Mr. Lim that he needed to quit in order to permanently treat his skin problems. He didn’t accept this answer and instead launched the literature review with colleagues Marshall Hall, MPH, also an osteopathic medical student with an interest in dermatology, and Sajid Surve, DO, codirector of the UNT Texas Center for Performing Arts Health.

Mr. Lim and colleagues evaluated 23 articles, which included case studies and literature reviews, about dermatitis in violinists, violists, cellists, bassists, guitarists and harpists. “Stringed instrumentalists are the highest at-risk population compared to performers who play other types of instruments,” Mr. Lim said.

The poster he presented at the meeting largely focuses on fiddler’s neck, which he defined as “simply dermatitis related to friction and allergic irritation from playing violin or viola.” Many people, he noted, are allergic to nickel, and the bracket that secures the violin’s chin rest “most often contains nickel. Even a very small concentration of nickel can cause massive reactions, and we found that the C string of a viola – the thickest, lowest-sounding string – contains a nickel concentration of up to 37%.”

Gold-coated strings are an alternative option, he said, but they’re more expensive.

Stringed instrumentalists may also be allergic to rosin applied to “bow hairs,” which is the hair – typically from horses – that is used to string bows, also described in the poster. “We found that there is an overall common allergy to the main ingredient called colophony,” Mr. Lim said. The legendary violin maker Antonio Stradivari “was rumored to have used colophony and another irritating ingredient called propolis in the wood varnish of his instruments. Because he was such a great influence on the art of violin crafting, his technique is still used in the modern era, which may be another contributing factor to the allergic reactions seen in stringed instrumentalists.”

(In the poster, the authors refer to one of the articles in the review, which described a violin maker allergic to colophony and propolis, who was treated with cetirizine, mild corticosteroids, and avoidance.)

What should dermatologists know about skin conditions in these musicians? Mr. Hall, one of the coauthors of the report, suggested they invite the patients to play their instruments during a visit. “The musicians may not understand that they are doing certain things with their movements, but looking from a clinical lens, we are able to see how their biomechanics and posture [are] contributing to their dermatitis,” he said.

Dr. Surve, the other coauthor, also suggested speaking to the patient’s teacher, coach, or mentor. “Keeping that person in the loop regarding what you are seeing and recommending will go a long way towards helping your patient,” he said. “If the teacher doesn’t understand or agree with what you’re trying to accomplish, they may try to undermine your plan of care. But if they are on board, they become a valuable tool for facilitating and reinforcing it.”

As for treatments, avoidance of the instruments is the most effective, but is simply not feasible for many musicians. “Certain interventions like creating a barrier between the musician and the instrument can reduce the risk of contact dermatitis without compromising the quality [of playing] as much,” Mr. Hall said. The poster reported that a handkerchief was used for this purpose in one case attributed to nickel sulfate in a 16-year-old .

Purchasing more expensive instrument materials to prevent reactions is another option, he said, and players can also purchase stands. But musicians may be resistant to any treatment that changes how the instruments sound or forces them to adjust the way they do things, he cautioned.

No funding for the study or author disclosures were reported.

Background: As technology and medical advances improve patient care, physicians and patients have become more dissatisfied with their interactions and relationships. Practices are needed to improve the connection between physician and patient.

Study design: Mixed-methods.

Setting: Three diverse primary care settings (academic medical center, Veterans Affairs facility, federally qualified health center).

Synopsis: Initial evidence- and narrative-based practices were identified from a systematic literature review, clinical observations of primary care encounters, and qualitative discussions with physicians, patients, and nonmedical professionals. A three-round modified Delphi process was performed with experts representing different aspects of the patient-physician relationship.

Five recommended clinical practices were recognized to foster presence and meaningful connections with patients: 1. Prepare with intention (becoming familiar with the patient before you meet them); 2. Listen intently and completely (sit down, lean forward, and don’t interrupt, but listen); 3. Agree on what matters most (discover your patient’s goals and fit them into the visit); 4. Connect with the patient’s story (take notice of efforts by the patient and successes); 5. Explore emotional cues (be aware of your patient’s emotions). Limitations of this study include the use of convenience sampling for the qualitative research, lack of international diversity of the expert panelists, and the lack of validation of the five practices as a whole.

Bottom line: The five practices of prepare with intention, listen intently and completely, agree on what matters most, connect with the patient’s story, and explore emotional cues may improve the patient-physician connection.

Citation: Zulman DM et al. Practices to foster physician presence and connection with patients in the clinical encounter. JAMA. 2020;323(1):70-81.

Dr. Trammell-Velasquez is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: As technology and medical advances improve patient care, physicians and patients have become more dissatisfied with their interactions and relationships. Practices are needed to improve the connection between physician and patient.

Study design: Mixed-methods.

Setting: Three diverse primary care settings (academic medical center, Veterans Affairs facility, federally qualified health center).

Synopsis: Initial evidence- and narrative-based practices were identified from a systematic literature review, clinical observations of primary care encounters, and qualitative discussions with physicians, patients, and nonmedical professionals. A three-round modified Delphi process was performed with experts representing different aspects of the patient-physician relationship.

Five recommended clinical practices were recognized to foster presence and meaningful connections with patients: 1. Prepare with intention (becoming familiar with the patient before you meet them); 2. Listen intently and completely (sit down, lean forward, and don’t interrupt, but listen); 3. Agree on what matters most (discover your patient’s goals and fit them into the visit); 4. Connect with the patient’s story (take notice of efforts by the patient and successes); 5. Explore emotional cues (be aware of your patient’s emotions). Limitations of this study include the use of convenience sampling for the qualitative research, lack of international diversity of the expert panelists, and the lack of validation of the five practices as a whole.

Bottom line: The five practices of prepare with intention, listen intently and completely, agree on what matters most, connect with the patient’s story, and explore emotional cues may improve the patient-physician connection.

Citation: Zulman DM et al. Practices to foster physician presence and connection with patients in the clinical encounter. JAMA. 2020;323(1):70-81.

Dr. Trammell-Velasquez is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

Background: As technology and medical advances improve patient care, physicians and patients have become more dissatisfied with their interactions and relationships. Practices are needed to improve the connection between physician and patient.

Study design: Mixed-methods.

Setting: Three diverse primary care settings (academic medical center, Veterans Affairs facility, federally qualified health center).

Synopsis: Initial evidence- and narrative-based practices were identified from a systematic literature review, clinical observations of primary care encounters, and qualitative discussions with physicians, patients, and nonmedical professionals. A three-round modified Delphi process was performed with experts representing different aspects of the patient-physician relationship.

Five recommended clinical practices were recognized to foster presence and meaningful connections with patients: 1. Prepare with intention (becoming familiar with the patient before you meet them); 2. Listen intently and completely (sit down, lean forward, and don’t interrupt, but listen); 3. Agree on what matters most (discover your patient’s goals and fit them into the visit); 4. Connect with the patient’s story (take notice of efforts by the patient and successes); 5. Explore emotional cues (be aware of your patient’s emotions). Limitations of this study include the use of convenience sampling for the qualitative research, lack of international diversity of the expert panelists, and the lack of validation of the five practices as a whole.

Bottom line: The five practices of prepare with intention, listen intently and completely, agree on what matters most, connect with the patient’s story, and explore emotional cues may improve the patient-physician connection.

Citation: Zulman DM et al. Practices to foster physician presence and connection with patients in the clinical encounter. JAMA. 2020;323(1):70-81.

Dr. Trammell-Velasquez is a hospitalist and associate professor of medicine at University of Texas Health, San Antonio.

OBSTETRIC ANAL SPHINCTER INJURY: PREVENTION AND REPAIR 

ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2021)

Experience with warm perineal compresses and massage

I have been a midwife for 45 years. I have used warm compresses on the perineum my whole career. I don't need data to tell me it provides comfort. My patients do. 
I don't do much massage of the perineum, only slightly while applying K-Y or another water-soluble gel. 

A slow, controlled extension of the vertex and healthy tissue is the best way to prevent tears. 

Karen Parker, MN, CNM 

Ashland, Oregon 

Dr. Barbieri responds 

I thank Ms. Parker for her clinical recommendation: "Yes to warm compresses" and "Massage of the perineum?" Not so much. 

Continue to: CESAREAN MYOMECTOMY...

 

 

CESAREAN MYOMECTOMY: SAFE OPERATION OR SURGICAL FOLLY? 

ROBERT L. BARBIERI, MD (EDITORIAL; FEBRUARY 2021) 

Timely comments on cesarean myomectomy 

Dr. Barbieri's editorial on cesarean myomectomy is very timely, especially the quote from Dr. K.S.J. Olah: "The berating I received was severe and disproportionate to the crime. The rule was that myomectomy performed at cesarean section was not just frowned upon but expressly forbidden." 

I had a very similar experience with panniculectomy and "tummy tuck" as a part of cesarean delivery (CD). Traditionally, a combination of a CD with any other surgical procedures (myomectomy, abdominoplasty, and so on) has not been accepted in the obstetric community. The main reason for such an opinion has been the unfounded fear of complications of combined procedures, including but not limited to infection, hematomas, and poor wound healing. None of these concerns have been supported by studies. Obvious advantages of combining a CD with other surgical procedures, including abdominoplasty, are obvious: the elimination of a second anesthesia, increased patient satisfaction, and no need for a second surgery. 

We reviewed the outcomes in 52 patients who underwent a combination of CD with other procedures (such as panniculectomy, abdominoplasty, hernia repairs, myomectomies, and ovarian biopsies). The postsurgical outcomes included in the analysis were postsurgical fever and the presence of seromas, hematomas, and wound dehiscence.¹ Twelve of our own patients had a panniculectomy during CD performed by a plastic surgeon. While the preoperative complications of panniculectomy may have been well described, there is a paucity of data in women who underwent the cosmetic procedure at the time of CD. We concluded that the performance of a panniculectomy and tummy tuck as part of a CD does not appear to increase surgical complications in patients with a high body mass index. Our preliminary results and call for further studies were received at the American College of Surgeons 2017 meeting in San Diego.² 

Boris Petrikovsky, MD, PhD 

Sunny Island Beach, Florida 

References 

1. Petrikovsky BM, Swancoat S, Zharov EV. Safety of panniculectomy during cesarean section: a prospective, non-randomized study. J Reprod Med. 2019;64:197-200. 
2. Petrikovsky BM. Is the combination of panniculectomy and cesarean section safe? Scientific Poster Presentation-Obstetrics and Gynecology. J Am Coll Surg. 2017;225(4 suppl 2):E130. 

Dr. Barbieri responds 

I agree with Dr. Petrikovsky that advances in the field of obstetrical surgery have been inhibited by a tendency to criticize innovation. Less than 40 years ago, leaders in gynecology did not initially accept the application of minimally invasive gynecology surgical techniques to common gyn procedures including hysterectomy. Every surgical field is rapidly innovating. Obstetrical surgeons should be encouraged to pursue new approaches, as you are doing. We wish you success in your pioneering work. 

Continue to: A CASE OF BV...

A CASE OF BV DURING PREGNANCY: BEST MANAGEMENT APPROACH 

CALLIE FOX REEDER, MD, AND PATRICK DUFF, MD (ID CONSULT; FEBRUARY 2021) 

Secnidazole for treatment of BV 

The article by Drs. Reeder and Duff incorrectly states that there are no single-dose therapeutic options for bacterial vaginosis (BV) in the United States. Secnidazole 2 g single oral dose was approved by the US Food and Drug Administration (FDA) in 2017, and it is now included in the American College of Obstetricians and Gynecologists' (ACOG) clinical management guidelines for the treatment of BV in nonpregnant patients. 

Secnidazole is not contraindicated in pregnancy. In a poster presented at the 2020 ACOG annual clinical meeting, we summarized results of the preclinical studies that were part of the FDA submission.¹ There was no evidence of secnidazole toxicity in fertility and pre- and postnatal reproductive toxicology studies. In addition, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose. These findings are consistent with the observation that no other preclinical studies, or experience from postmarketing use of secnidazole for approved indications, have suggested a risk of adverse effects when using secnidazole in pregnancy. 

Steven E. Chavoustie, MD 

North Miami, Florida 

Reference 

1. Pentikis H, Eder S, Kaufman G, Chavoustie S. Secnidazole, an approved single dose drug for bacterial vaginosis, does not cause reproductive toxicity in animals [16A]. Obstet Gynecol. 2020;135:12S. 

Drs. Reeder and Duff respond 

We are very appreciative of Dr. Chavoustie's interest in our article and for his thoughtful assessment of the role of single-dose secnidazole for the treatment of BV. As we noted in our article, this drug has been used extensively in Europe and Asia, but there is much less published experience with the drug in the United States. We pointed out the excellent results reported by Hillier and colleagues with 1-g and 2-g doses of this medication.¹ Dr. Chavoustie is correct in stating that there is no risk of fetal harm based on animal data at up to 4 times the recommended human dose, although the manufacturer recommends discontinuing breastfeeding during, and for 96 hours after, treatment. According to www.goodrx.com, the cost of a single 2-g dose of secnidazole is $325; the cost of a 7-day course of metronidazole is approximately $16. 

Reference 

1. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130:379-386. 

Continue to: OPTIMIZING THE USE OF...

 

 

OPTIMIZING THE USE OF OXYTOCIN ON LABOR AND DELIVERY 

ROBERT L. BARBIERI, MD (EDITORIAL; JANUARY 2021) 

Vigilant labor progress aids in oxytocin optimization 

I read with particular interest Dr. Barbieri's editorial on optimizing oxytocin infusion. This topic is relevant for my practice as I am the kind of physician described and I usually get upset when the oxytocin is not managed as I ordered. 

In my opinion, several things need clarification. On our unit, the most significant point of controversy is the definition of tachysystole, mainly when we are using a tocodynamometer and not an internal transducer. 

I contend that it is quite challenging to ascertain the effectiveness of any given labor pattern based only on the number of contractions. Although we joke about "pit to distress," the truth is that contractions need to be "effective," which to me means strong enough to induce cervical changes. 

In my clinical practice, with a tocodynamometer, having 5 contractions that do not produce cervical changes (unless associated with abnormalities of the fetal heart rate tracing) is not a clinically relevant finding as we do not have a way to gauge the strength of such contractions. 

I usually employ a mid-range oxytocin protocol, starting at 4 mU per minute and increasing by 4 mU every 20 minutes. Through 30 years of practicing obstetrics, I have found that this protocol renders excellent results in achieving an efficient labor pattern without jeopardizing fetal well-being. 

On learning about oxytocin's pharmacokinetics, I still support Dr. Rhonda L. Perry and her colleagues' conclusion that, until we learn better about this aspect of oxytocin pharmacology, each woman is her own bioassay.¹ Furthermore, we see this in our daily practice: some patients go into full efficient labor with oxytocin at 4 mU per minute while others at 30 mU per minute do zilch. 

Based on the above, I think that optimization requires close vigilance of the labor and the fetal status at any given time, not determining an oxytocin rate of infusion or dosage. 
We should be observant on evaluating labor progress, and we should not hesitate to use internal pressure catheters when needed to obtain a more accurate evaluation of the labor pattern. 

By examining the patient's labor progress at regular intervals, we also optimize the oxytocin infusion by determining if the infusion is producing the expected cervical changes. 

Tomas Hernandez-Mejia, MD 

Pasco, Washington 

Reference
 
1. Perry RL, Satin AJ, Barth WH, et al. The pharmacokinetics of oxytocin as they apply to labor induction. Am J Obstet Gynecol. 1996;174:1590-1593. 

Dr. Barbieri responds 

I thank Dr. Tomas Hernandez-Mejia for sharing his expertise in utilizing a higher dose of oxytocin to optimize labor and birth. Dr. Hernandez-Mejia's view is supported by the recent publication of a high-quality clinical trial showing that a high-dose oxytocin protocol (initial and incremental rate of 6 mIU/min) did not cause an increase in adverse perinatal outcomes compared with a standard-dose protocol (initial and incremental rate of 2 mIU/min) but slightly shortened the duration of labor.¹ Based on this clinical trial, my conclusion is that the high-dose protocol, if appropriately monitored for excess uterine contractions and fetal heart rate pattern, is safe. 

Reference 

1. Son M, Roy A, Stetson BT, et al. High-dose compared with standard-dose oxytocin regimens to augment labor in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2021;137:991-998. 

Continue to: PREGNANCY OF UNKNOWN...

 

 

PREGNANCY OF UNKNOWN LOCATION: EVIDENCE-BASED EVALUATION AND MANAGEMENT 

IRIS G. INSOGNA, MD, AND PAULA C. BRADY, MD (AUGUST 2020) 

I would like to thank Dr. Iris Insogna and Dr. Paula Brady for their very informative article on pregnancy of unknown location. However, please allow me to make a suggestion that will clarify terminology for all practicing ObGyns. 

The medical literature uses the terms cornual pregnancy and interstitial pregnancy interchangeably, although they are actually very different conditions and have significant different implications. Clinicians are often confused about which is an intrauterine pregnancy and which is a true ectopic pregnancy. This confusion was addressed in a 2006 article in Fertility and Sterility, which explains that a cornual pregnancy refers to the implantation and development of a gestation in one of the upper and lateral portions of the uterus.¹ This may occur in a rudimentary horn or in one horn of a septate or bicornuate uterus. Conversely, an interstitial pregnancy is a gestation that implants within the proximal, intramural portion of the fallopian tube that is enveloped by myometrium. Therefore, a cornual pregnancy is actually an intrauterine pregnancy, whereas an interstitial pregnancy is a true ectopic pregnancy. 

I hope that all clinicians will read the article in Fertility and Sterility and adopt this terminology to avoid future confusion and misunderstandings. 

Alan D. Rosen, MD 

Houston, Texas 

Reference 

1. Malinowski A, Bates SK. Semantics and pitfalls in the diagnosis of cornual/interstitial pregnancy. Fertil Steril. 2006;86:1764.e11-1764.e14.

OBSTETRIC ANAL SPHINCTER INJURY: PREVENTION AND REPAIR 

ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2021)

Experience with warm perineal compresses and massage

I have been a midwife for 45 years. I have used warm compresses on the perineum my whole career. I don't need data to tell me it provides comfort. My patients do. 
I don't do much massage of the perineum, only slightly while applying K-Y or another water-soluble gel. 

A slow, controlled extension of the vertex and healthy tissue is the best way to prevent tears. 

Karen Parker, MN, CNM 

Ashland, Oregon 

Dr. Barbieri responds 

I thank Ms. Parker for her clinical recommendation: "Yes to warm compresses" and "Massage of the perineum?" Not so much. 

Continue to: CESAREAN MYOMECTOMY...

 

 

CESAREAN MYOMECTOMY: SAFE OPERATION OR SURGICAL FOLLY? 

ROBERT L. BARBIERI, MD (EDITORIAL; FEBRUARY 2021) 

Timely comments on cesarean myomectomy 

Dr. Barbieri's editorial on cesarean myomectomy is very timely, especially the quote from Dr. K.S.J. Olah: "The berating I received was severe and disproportionate to the crime. The rule was that myomectomy performed at cesarean section was not just frowned upon but expressly forbidden." 

I had a very similar experience with panniculectomy and "tummy tuck" as a part of cesarean delivery (CD). Traditionally, a combination of a CD with any other surgical procedures (myomectomy, abdominoplasty, and so on) has not been accepted in the obstetric community. The main reason for such an opinion has been the unfounded fear of complications of combined procedures, including but not limited to infection, hematomas, and poor wound healing. None of these concerns have been supported by studies. Obvious advantages of combining a CD with other surgical procedures, including abdominoplasty, are obvious: the elimination of a second anesthesia, increased patient satisfaction, and no need for a second surgery. 

We reviewed the outcomes in 52 patients who underwent a combination of CD with other procedures (such as panniculectomy, abdominoplasty, hernia repairs, myomectomies, and ovarian biopsies). The postsurgical outcomes included in the analysis were postsurgical fever and the presence of seromas, hematomas, and wound dehiscence.¹ Twelve of our own patients had a panniculectomy during CD performed by a plastic surgeon. While the preoperative complications of panniculectomy may have been well described, there is a paucity of data in women who underwent the cosmetic procedure at the time of CD. We concluded that the performance of a panniculectomy and tummy tuck as part of a CD does not appear to increase surgical complications in patients with a high body mass index. Our preliminary results and call for further studies were received at the American College of Surgeons 2017 meeting in San Diego.² 

Boris Petrikovsky, MD, PhD 

Sunny Island Beach, Florida 

References 

1. Petrikovsky BM, Swancoat S, Zharov EV. Safety of panniculectomy during cesarean section: a prospective, non-randomized study. J Reprod Med. 2019;64:197-200. 
2. Petrikovsky BM. Is the combination of panniculectomy and cesarean section safe? Scientific Poster Presentation-Obstetrics and Gynecology. J Am Coll Surg. 2017;225(4 suppl 2):E130. 

Dr. Barbieri responds 

I agree with Dr. Petrikovsky that advances in the field of obstetrical surgery have been inhibited by a tendency to criticize innovation. Less than 40 years ago, leaders in gynecology did not initially accept the application of minimally invasive gynecology surgical techniques to common gyn procedures including hysterectomy. Every surgical field is rapidly innovating. Obstetrical surgeons should be encouraged to pursue new approaches, as you are doing. We wish you success in your pioneering work. 

Continue to: A CASE OF BV...

A CASE OF BV DURING PREGNANCY: BEST MANAGEMENT APPROACH 

CALLIE FOX REEDER, MD, AND PATRICK DUFF, MD (ID CONSULT; FEBRUARY 2021) 

Secnidazole for treatment of BV 

The article by Drs. Reeder and Duff incorrectly states that there are no single-dose therapeutic options for bacterial vaginosis (BV) in the United States. Secnidazole 2 g single oral dose was approved by the US Food and Drug Administration (FDA) in 2017, and it is now included in the American College of Obstetricians and Gynecologists' (ACOG) clinical management guidelines for the treatment of BV in nonpregnant patients. 

Secnidazole is not contraindicated in pregnancy. In a poster presented at the 2020 ACOG annual clinical meeting, we summarized results of the preclinical studies that were part of the FDA submission.¹ There was no evidence of secnidazole toxicity in fertility and pre- and postnatal reproductive toxicology studies. In addition, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose. These findings are consistent with the observation that no other preclinical studies, or experience from postmarketing use of secnidazole for approved indications, have suggested a risk of adverse effects when using secnidazole in pregnancy. 

Steven E. Chavoustie, MD 

North Miami, Florida 

Reference 

1. Pentikis H, Eder S, Kaufman G, Chavoustie S. Secnidazole, an approved single dose drug for bacterial vaginosis, does not cause reproductive toxicity in animals [16A]. Obstet Gynecol. 2020;135:12S. 

Drs. Reeder and Duff respond 

We are very appreciative of Dr. Chavoustie's interest in our article and for his thoughtful assessment of the role of single-dose secnidazole for the treatment of BV. As we noted in our article, this drug has been used extensively in Europe and Asia, but there is much less published experience with the drug in the United States. We pointed out the excellent results reported by Hillier and colleagues with 1-g and 2-g doses of this medication.¹ Dr. Chavoustie is correct in stating that there is no risk of fetal harm based on animal data at up to 4 times the recommended human dose, although the manufacturer recommends discontinuing breastfeeding during, and for 96 hours after, treatment. According to www.goodrx.com, the cost of a single 2-g dose of secnidazole is $325; the cost of a 7-day course of metronidazole is approximately $16. 

Reference 

1. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130:379-386. 

Continue to: OPTIMIZING THE USE OF...

 

 

OPTIMIZING THE USE OF OXYTOCIN ON LABOR AND DELIVERY 

ROBERT L. BARBIERI, MD (EDITORIAL; JANUARY 2021) 

Vigilant labor progress aids in oxytocin optimization 

I read with particular interest Dr. Barbieri's editorial on optimizing oxytocin infusion. This topic is relevant for my practice as I am the kind of physician described and I usually get upset when the oxytocin is not managed as I ordered. 

In my opinion, several things need clarification. On our unit, the most significant point of controversy is the definition of tachysystole, mainly when we are using a tocodynamometer and not an internal transducer. 

I contend that it is quite challenging to ascertain the effectiveness of any given labor pattern based only on the number of contractions. Although we joke about "pit to distress," the truth is that contractions need to be "effective," which to me means strong enough to induce cervical changes. 

In my clinical practice, with a tocodynamometer, having 5 contractions that do not produce cervical changes (unless associated with abnormalities of the fetal heart rate tracing) is not a clinically relevant finding as we do not have a way to gauge the strength of such contractions. 

I usually employ a mid-range oxytocin protocol, starting at 4 mU per minute and increasing by 4 mU every 20 minutes. Through 30 years of practicing obstetrics, I have found that this protocol renders excellent results in achieving an efficient labor pattern without jeopardizing fetal well-being. 

On learning about oxytocin's pharmacokinetics, I still support Dr. Rhonda L. Perry and her colleagues' conclusion that, until we learn better about this aspect of oxytocin pharmacology, each woman is her own bioassay.¹ Furthermore, we see this in our daily practice: some patients go into full efficient labor with oxytocin at 4 mU per minute while others at 30 mU per minute do zilch. 

Based on the above, I think that optimization requires close vigilance of the labor and the fetal status at any given time, not determining an oxytocin rate of infusion or dosage. 
We should be observant on evaluating labor progress, and we should not hesitate to use internal pressure catheters when needed to obtain a more accurate evaluation of the labor pattern. 

By examining the patient's labor progress at regular intervals, we also optimize the oxytocin infusion by determining if the infusion is producing the expected cervical changes. 

Tomas Hernandez-Mejia, MD 

Pasco, Washington 

Reference
 
1. Perry RL, Satin AJ, Barth WH, et al. The pharmacokinetics of oxytocin as they apply to labor induction. Am J Obstet Gynecol. 1996;174:1590-1593. 

Dr. Barbieri responds 

I thank Dr. Tomas Hernandez-Mejia for sharing his expertise in utilizing a higher dose of oxytocin to optimize labor and birth. Dr. Hernandez-Mejia's view is supported by the recent publication of a high-quality clinical trial showing that a high-dose oxytocin protocol (initial and incremental rate of 6 mIU/min) did not cause an increase in adverse perinatal outcomes compared with a standard-dose protocol (initial and incremental rate of 2 mIU/min) but slightly shortened the duration of labor.¹ Based on this clinical trial, my conclusion is that the high-dose protocol, if appropriately monitored for excess uterine contractions and fetal heart rate pattern, is safe. 

Reference 

1. Son M, Roy A, Stetson BT, et al. High-dose compared with standard-dose oxytocin regimens to augment labor in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2021;137:991-998. 

Continue to: PREGNANCY OF UNKNOWN...

 

 

PREGNANCY OF UNKNOWN LOCATION: EVIDENCE-BASED EVALUATION AND MANAGEMENT 

IRIS G. INSOGNA, MD, AND PAULA C. BRADY, MD (AUGUST 2020) 

I would like to thank Dr. Iris Insogna and Dr. Paula Brady for their very informative article on pregnancy of unknown location. However, please allow me to make a suggestion that will clarify terminology for all practicing ObGyns. 

The medical literature uses the terms cornual pregnancy and interstitial pregnancy interchangeably, although they are actually very different conditions and have significant different implications. Clinicians are often confused about which is an intrauterine pregnancy and which is a true ectopic pregnancy. This confusion was addressed in a 2006 article in Fertility and Sterility, which explains that a cornual pregnancy refers to the implantation and development of a gestation in one of the upper and lateral portions of the uterus.¹ This may occur in a rudimentary horn or in one horn of a septate or bicornuate uterus. Conversely, an interstitial pregnancy is a gestation that implants within the proximal, intramural portion of the fallopian tube that is enveloped by myometrium. Therefore, a cornual pregnancy is actually an intrauterine pregnancy, whereas an interstitial pregnancy is a true ectopic pregnancy. 

I hope that all clinicians will read the article in Fertility and Sterility and adopt this terminology to avoid future confusion and misunderstandings. 

Alan D. Rosen, MD 

Houston, Texas 

Reference 

1. Malinowski A, Bates SK. Semantics and pitfalls in the diagnosis of cornual/interstitial pregnancy. Fertil Steril. 2006;86:1764.e11-1764.e14.

OBSTETRIC ANAL SPHINCTER INJURY: PREVENTION AND REPAIR 

ROBERT L. BARBIERI, MD (EDITORIAL; MAY 2021)

Experience with warm perineal compresses and massage

I have been a midwife for 45 years. I have used warm compresses on the perineum my whole career. I don't need data to tell me it provides comfort. My patients do. 
I don't do much massage of the perineum, only slightly while applying K-Y or another water-soluble gel. 

A slow, controlled extension of the vertex and healthy tissue is the best way to prevent tears. 

Karen Parker, MN, CNM 

Ashland, Oregon 

Dr. Barbieri responds 

I thank Ms. Parker for her clinical recommendation: "Yes to warm compresses" and "Massage of the perineum?" Not so much. 

Continue to: CESAREAN MYOMECTOMY...

 

 

CESAREAN MYOMECTOMY: SAFE OPERATION OR SURGICAL FOLLY? 

ROBERT L. BARBIERI, MD (EDITORIAL; FEBRUARY 2021) 

Timely comments on cesarean myomectomy 

Dr. Barbieri's editorial on cesarean myomectomy is very timely, especially the quote from Dr. K.S.J. Olah: "The berating I received was severe and disproportionate to the crime. The rule was that myomectomy performed at cesarean section was not just frowned upon but expressly forbidden." 

I had a very similar experience with panniculectomy and "tummy tuck" as a part of cesarean delivery (CD). Traditionally, a combination of a CD with any other surgical procedures (myomectomy, abdominoplasty, and so on) has not been accepted in the obstetric community. The main reason for such an opinion has been the unfounded fear of complications of combined procedures, including but not limited to infection, hematomas, and poor wound healing. None of these concerns have been supported by studies. Obvious advantages of combining a CD with other surgical procedures, including abdominoplasty, are obvious: the elimination of a second anesthesia, increased patient satisfaction, and no need for a second surgery. 

We reviewed the outcomes in 52 patients who underwent a combination of CD with other procedures (such as panniculectomy, abdominoplasty, hernia repairs, myomectomies, and ovarian biopsies). The postsurgical outcomes included in the analysis were postsurgical fever and the presence of seromas, hematomas, and wound dehiscence.¹ Twelve of our own patients had a panniculectomy during CD performed by a plastic surgeon. While the preoperative complications of panniculectomy may have been well described, there is a paucity of data in women who underwent the cosmetic procedure at the time of CD. We concluded that the performance of a panniculectomy and tummy tuck as part of a CD does not appear to increase surgical complications in patients with a high body mass index. Our preliminary results and call for further studies were received at the American College of Surgeons 2017 meeting in San Diego.² 

Boris Petrikovsky, MD, PhD 

Sunny Island Beach, Florida 

References 

1. Petrikovsky BM, Swancoat S, Zharov EV. Safety of panniculectomy during cesarean section: a prospective, non-randomized study. J Reprod Med. 2019;64:197-200. 
2. Petrikovsky BM. Is the combination of panniculectomy and cesarean section safe? Scientific Poster Presentation-Obstetrics and Gynecology. J Am Coll Surg. 2017;225(4 suppl 2):E130. 

Dr. Barbieri responds 

I agree with Dr. Petrikovsky that advances in the field of obstetrical surgery have been inhibited by a tendency to criticize innovation. Less than 40 years ago, leaders in gynecology did not initially accept the application of minimally invasive gynecology surgical techniques to common gyn procedures including hysterectomy. Every surgical field is rapidly innovating. Obstetrical surgeons should be encouraged to pursue new approaches, as you are doing. We wish you success in your pioneering work. 

Continue to: A CASE OF BV...

A CASE OF BV DURING PREGNANCY: BEST MANAGEMENT APPROACH 

CALLIE FOX REEDER, MD, AND PATRICK DUFF, MD (ID CONSULT; FEBRUARY 2021) 

Secnidazole for treatment of BV 

The article by Drs. Reeder and Duff incorrectly states that there are no single-dose therapeutic options for bacterial vaginosis (BV) in the United States. Secnidazole 2 g single oral dose was approved by the US Food and Drug Administration (FDA) in 2017, and it is now included in the American College of Obstetricians and Gynecologists' (ACOG) clinical management guidelines for the treatment of BV in nonpregnant patients. 

Secnidazole is not contraindicated in pregnancy. In a poster presented at the 2020 ACOG annual clinical meeting, we summarized results of the preclinical studies that were part of the FDA submission.¹ There was no evidence of secnidazole toxicity in fertility and pre- and postnatal reproductive toxicology studies. In addition, there were no adverse developmental outcomes when secnidazole was administered orally to pregnant rats and rabbits during organogenesis at doses up to 4 times the clinical dose. These findings are consistent with the observation that no other preclinical studies, or experience from postmarketing use of secnidazole for approved indications, have suggested a risk of adverse effects when using secnidazole in pregnancy. 

Steven E. Chavoustie, MD 

North Miami, Florida 

Reference 

1. Pentikis H, Eder S, Kaufman G, Chavoustie S. Secnidazole, an approved single dose drug for bacterial vaginosis, does not cause reproductive toxicity in animals [16A]. Obstet Gynecol. 2020;135:12S. 

Drs. Reeder and Duff respond 

We are very appreciative of Dr. Chavoustie's interest in our article and for his thoughtful assessment of the role of single-dose secnidazole for the treatment of BV. As we noted in our article, this drug has been used extensively in Europe and Asia, but there is much less published experience with the drug in the United States. We pointed out the excellent results reported by Hillier and colleagues with 1-g and 2-g doses of this medication.¹ Dr. Chavoustie is correct in stating that there is no risk of fetal harm based on animal data at up to 4 times the recommended human dose, although the manufacturer recommends discontinuing breastfeeding during, and for 96 hours after, treatment. According to www.goodrx.com, the cost of a single 2-g dose of secnidazole is $325; the cost of a 7-day course of metronidazole is approximately $16. 

Reference 

1. Hillier SL, Nyirjesy P, Waldbaum AS, et al. Secnidazole treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2017;130:379-386. 

Continue to: OPTIMIZING THE USE OF...

 

 

OPTIMIZING THE USE OF OXYTOCIN ON LABOR AND DELIVERY 

ROBERT L. BARBIERI, MD (EDITORIAL; JANUARY 2021) 

Vigilant labor progress aids in oxytocin optimization 

I read with particular interest Dr. Barbieri's editorial on optimizing oxytocin infusion. This topic is relevant for my practice as I am the kind of physician described and I usually get upset when the oxytocin is not managed as I ordered. 

In my opinion, several things need clarification. On our unit, the most significant point of controversy is the definition of tachysystole, mainly when we are using a tocodynamometer and not an internal transducer. 

I contend that it is quite challenging to ascertain the effectiveness of any given labor pattern based only on the number of contractions. Although we joke about "pit to distress," the truth is that contractions need to be "effective," which to me means strong enough to induce cervical changes. 

In my clinical practice, with a tocodynamometer, having 5 contractions that do not produce cervical changes (unless associated with abnormalities of the fetal heart rate tracing) is not a clinically relevant finding as we do not have a way to gauge the strength of such contractions. 

I usually employ a mid-range oxytocin protocol, starting at 4 mU per minute and increasing by 4 mU every 20 minutes. Through 30 years of practicing obstetrics, I have found that this protocol renders excellent results in achieving an efficient labor pattern without jeopardizing fetal well-being. 

On learning about oxytocin's pharmacokinetics, I still support Dr. Rhonda L. Perry and her colleagues' conclusion that, until we learn better about this aspect of oxytocin pharmacology, each woman is her own bioassay.¹ Furthermore, we see this in our daily practice: some patients go into full efficient labor with oxytocin at 4 mU per minute while others at 30 mU per minute do zilch. 

Based on the above, I think that optimization requires close vigilance of the labor and the fetal status at any given time, not determining an oxytocin rate of infusion or dosage. 
We should be observant on evaluating labor progress, and we should not hesitate to use internal pressure catheters when needed to obtain a more accurate evaluation of the labor pattern. 

By examining the patient's labor progress at regular intervals, we also optimize the oxytocin infusion by determining if the infusion is producing the expected cervical changes. 

Tomas Hernandez-Mejia, MD 

Pasco, Washington 

Reference
 
1. Perry RL, Satin AJ, Barth WH, et al. The pharmacokinetics of oxytocin as they apply to labor induction. Am J Obstet Gynecol. 1996;174:1590-1593. 

Dr. Barbieri responds 

I thank Dr. Tomas Hernandez-Mejia for sharing his expertise in utilizing a higher dose of oxytocin to optimize labor and birth. Dr. Hernandez-Mejia's view is supported by the recent publication of a high-quality clinical trial showing that a high-dose oxytocin protocol (initial and incremental rate of 6 mIU/min) did not cause an increase in adverse perinatal outcomes compared with a standard-dose protocol (initial and incremental rate of 2 mIU/min) but slightly shortened the duration of labor.¹ Based on this clinical trial, my conclusion is that the high-dose protocol, if appropriately monitored for excess uterine contractions and fetal heart rate pattern, is safe. 

Reference 

1. Son M, Roy A, Stetson BT, et al. High-dose compared with standard-dose oxytocin regimens to augment labor in nulliparous women: a randomized controlled trial. Obstet Gynecol. 2021;137:991-998. 

Continue to: PREGNANCY OF UNKNOWN...

 

 

PREGNANCY OF UNKNOWN LOCATION: EVIDENCE-BASED EVALUATION AND MANAGEMENT 

IRIS G. INSOGNA, MD, AND PAULA C. BRADY, MD (AUGUST 2020) 

I would like to thank Dr. Iris Insogna and Dr. Paula Brady for their very informative article on pregnancy of unknown location. However, please allow me to make a suggestion that will clarify terminology for all practicing ObGyns. 

The medical literature uses the terms cornual pregnancy and interstitial pregnancy interchangeably, although they are actually very different conditions and have significant different implications. Clinicians are often confused about which is an intrauterine pregnancy and which is a true ectopic pregnancy. This confusion was addressed in a 2006 article in Fertility and Sterility, which explains that a cornual pregnancy refers to the implantation and development of a gestation in one of the upper and lateral portions of the uterus.¹ This may occur in a rudimentary horn or in one horn of a septate or bicornuate uterus. Conversely, an interstitial pregnancy is a gestation that implants within the proximal, intramural portion of the fallopian tube that is enveloped by myometrium. Therefore, a cornual pregnancy is actually an intrauterine pregnancy, whereas an interstitial pregnancy is a true ectopic pregnancy. 

I hope that all clinicians will read the article in Fertility and Sterility and adopt this terminology to avoid future confusion and misunderstandings. 

Alan D. Rosen, MD 

Houston, Texas 

Reference 

1. Malinowski A, Bates SK. Semantics and pitfalls in the diagnosis of cornual/interstitial pregnancy. Fertil Steril. 2006;86:1764.e11-1764.e14.

Congratulations! You have matched in a competitive medical subspecialty or you have secured your first faculty position. But what do you do now? Success in your early career – as a new fellow or a new attending – requires both hard work and perseverance. We present our top 12 tips for how to be successful as you transition into your new position.

Tip #1: Be kind to yourself

As you transition from medical resident to GI fellow or from GI fellow to first-time attending, it is important to recognize that you are going through a major career transition (not as major as fourth year to intern, but probably a close second). First and foremost, remember to be kind to yourself and set reasonable expectations. You need to allow yourself time to transition to a new role which may also be in a new city or state. Take care of yourself – don’t forget to exercise, eat well, and sleep. You are in the long game now. Work to get yourself in a routine that is sustainable. Block out time to exercise, explore your new city, meal plan, and pursue your interests outside of medicine.

Tip #2: Set up for success

Since you are going through this major life/career transition, it is really helpful if you can set yourself up for success by having some projects that are easily completed during this challenging time so that you can demonstrate success. If you have projects in different stages of development, you will always have something you can work on when some projects are delayed for reasons outside of your control. In particular, it is great to have a few papers ready to go during late fellowship so they are published during your first year as an academic attending! This will allow you to continue your research trajectory as you learn the ropes of your new position.

Tip #3: Ask for help

It turns out you cannot do everything on your own! Make sure you are getting help professionally and personally so that you are set up for success. It’s okay to feel overwhelmed or confused; we all do at some point or another. Fellowship and early academic faculty years are stressful and nobody expects you to do it alone. Chances are your mentors or cofellows have had similar struggles, and in opening up, this dialogue may help you both.
 

Tip #4: Write out your 5-year plan

You need to know where you are going before you can figure out how to get there. Take some time for “soul searching”: Think about where you would like to be in 5 years and work backward (along with help from your mentors; see Tip #5) to determine how best to get there. If you think a career in academia might be for you, it’s never too soon to start networking and involving yourself in research. If a specific institution or clinical position draws your attention, check out the current faculty. You can use their CVs as a roadmap of types of experiences and honors that should be on your radar throughout these 5 years. Remember that your 5-year plan is not written in stone – this is something that you should re-evaluate as your interests and priorities change throughout your career.
 

Tip #5: Develop your personal ‘Board of Directors’

Instead of trying to find the perfect mentor, we suggest you seek out a personal “Board of Directors” who can serve as your mentoring team. There will never be a single perfect mentor for you and it is likely that you will need separate mentors to help guide you on different aspects of your career. I personally have separate individuals serving as my clinical mentor, my research content mentor, my research methods mentor, my career mentor, and my personal/life mentor. Having multiple mentors allows you to maximize the impact of your different mentors’ strengths across each component of your career. Further, your mentors themselves may have past histories of collaboration that you may then leverage to buoy your own fledgling career. When deciding on who to choose as a mentor, it is important to talk to prior mentees about their experiences with a mentor to help you decide if you may be a good match.
 

Tip #6: Master the art of “Menteering”

Now that you have identified mentors, you need to do your part in nurturing this mentee-mentor relationship. Be an excellent mentee: Show up, stick to a timeline, bring ideas and enthusiasm, and make it easy for your mentor. Your mentors want to see you succeed and sometimes this requires you to help them help you. If you know your own learning style and how you like to interact, have that conversation with your mentor upfront (for example, you may need strict deadlines or you may prefer having more time to develop ideas). Having these conversations before you start a project or a relationship will help set the expectations and ensure effective communication with your mentor. If you find that your mentor is doing something that hinders your progress, such as asking for updates too often or not checking in enough, have a constructive conversation with them about how you feel. Come prepared for meetings with your mentor with an agenda and timeline. Be specific if there is something you need from your mentor and be respectful of their other commitments. For example, if you would like your mentor to review your grant application, let them know the grant deadline and find out when you need to get them a draft so that they will have time to provide meaningful feedback.
 

Tip #7: Identify sponsors

Equally, if not more important than your mentoring team, are sponsors. These are people in positions of power who will promote you and help push your career forward. Sponsors can be people more senior to you, cofellows, or even acquaintances in industry or pharmaceuticals. Your mentor may also be your sponsor, but not always. As early academic faculty, it is important to get your name out there with speaking engagements related to your clinical and research niche, and that is one way a sponsor can help bolster your career.

Tip #8: Develop your personal brand – what is on your T-shirt?

As medicine becomes more and more subspecialized, finding your brand is becoming increasingly important. A brand could be anything from your academic niche to social justice, or even social media utilization. Your brand should encompass what you are naturally excited by within your field. Finding your brand will not only distinguish you from your peers but will also provide you with expertise which you can then offer to your colleagues, near and far. Practice the “elevator pitch” of your personal brand so that you can effectively (and efficiently) describe yourself and your interests when meeting new people and networking.
 

Tip #9: Meet thought leaders in your field

Think of the top five or six most prominent and influential people in your area of clinical or research interest and introduce yourself. This can be done at a national meeting or simply over email, though in person is always best if possible. Although thought leaders are busy, in my experience, if you are persistent, you can always find a few minutes to make an introduction. I’ve shared cab rides just to get a few minutes of someone’s time. In my first few years on faculty, I met with most of the thought leaders in my field; some of these meetings led to fruitful collaborations and important introductions (see tip #7). Meet others at your career level too. They can be great to bounce ideas off, and they will be future leaders in the field. Inviting thought leaders to come to your institution to give talks (in-person or virtually) is another great way to show your interest in their work and also find time to introduce yourself.
 

Tip #10: Apply, apply, apply

Remember that feedback is a gift and the best way to receive feedback is to apply to as many opportunities as you can. Any successful person in GI will have a ‘CV of failures’ far longer than their actual CV documenting their successes. I applied to 8 grants before landing my first one, but I received invaluable feedback and improved my writing skills in the process. Success in fellowship and early faculty takes immense grit – work on building a thick skin and finding the learning opportunity within any outcome.
 

Tip #11: Don’t get sucked into the email abyss

It is easy to fill your time completing low priority, but easy to complete, tasks such as responding to emails. Time management is key and you need to make sure that you dedicate time to more time-consuming tasks – such as writing and developing projects/grants – that have a high reward. Dedicate time on your calendar for high-priority tasks and make sure you don’t open your email during this time. Turn off the email pop-up window and do emails at the end of the day (or whenever you are done writing and thinking). Limiting distractions will help get your creative juices flowing.
 

Tip #12: Don’t always say yes

In fact, don’t ever say yes to a career or research opportunity within the first 24 hours to allow yourself time to weigh the pros and cons of the commitment, to assess the timeline feasibility, and to decide it fits into your 5-year plan. You can say you need to talk to your mentor about it first. If you decide you cannot accept an opportunity, a great way to mitigate that is to simply say “I’d love to, but my mentor says no.” Act as a sponsor to someone else by suggesting a potential colleague who might be interested in the opportunity. As you accept more responsibilities, think about what you might be able to give up to give yourself time to be successful in this new opportunity (and not distract from yourself or your 5-year plan).  
 

Conclusion

Success in research and early academic faculty years takes planning and determination. We hope these tips provide a broad outline for what to think about and how to approach planning your future career. First and foremost, you must put in the time to think about what you really want and what will make you happy in the long run. Academic success is a broad term that each of us defines differently. What does it mean to you? Once you figure that out, make your 5-year plan and run with it!

Dr. Rebello and Dr. Long are with section of gastroenterology at Boston Medical Center and Boston University. They have no conflicts to report.

Congratulations! You have matched in a competitive medical subspecialty or you have secured your first faculty position. But what do you do now? Success in your early career – as a new fellow or a new attending – requires both hard work and perseverance. We present our top 12 tips for how to be successful as you transition into your new position.

Tip #1: Be kind to yourself

As you transition from medical resident to GI fellow or from GI fellow to first-time attending, it is important to recognize that you are going through a major career transition (not as major as fourth year to intern, but probably a close second). First and foremost, remember to be kind to yourself and set reasonable expectations. You need to allow yourself time to transition to a new role which may also be in a new city or state. Take care of yourself – don’t forget to exercise, eat well, and sleep. You are in the long game now. Work to get yourself in a routine that is sustainable. Block out time to exercise, explore your new city, meal plan, and pursue your interests outside of medicine.

Tip #2: Set up for success

Since you are going through this major life/career transition, it is really helpful if you can set yourself up for success by having some projects that are easily completed during this challenging time so that you can demonstrate success. If you have projects in different stages of development, you will always have something you can work on when some projects are delayed for reasons outside of your control. In particular, it is great to have a few papers ready to go during late fellowship so they are published during your first year as an academic attending! This will allow you to continue your research trajectory as you learn the ropes of your new position.

Tip #3: Ask for help

It turns out you cannot do everything on your own! Make sure you are getting help professionally and personally so that you are set up for success. It’s okay to feel overwhelmed or confused; we all do at some point or another. Fellowship and early academic faculty years are stressful and nobody expects you to do it alone. Chances are your mentors or cofellows have had similar struggles, and in opening up, this dialogue may help you both.
 

Tip #4: Write out your 5-year plan

You need to know where you are going before you can figure out how to get there. Take some time for “soul searching”: Think about where you would like to be in 5 years and work backward (along with help from your mentors; see Tip #5) to determine how best to get there. If you think a career in academia might be for you, it’s never too soon to start networking and involving yourself in research. If a specific institution or clinical position draws your attention, check out the current faculty. You can use their CVs as a roadmap of types of experiences and honors that should be on your radar throughout these 5 years. Remember that your 5-year plan is not written in stone – this is something that you should re-evaluate as your interests and priorities change throughout your career.
 

Tip #5: Develop your personal ‘Board of Directors’

Instead of trying to find the perfect mentor, we suggest you seek out a personal “Board of Directors” who can serve as your mentoring team. There will never be a single perfect mentor for you and it is likely that you will need separate mentors to help guide you on different aspects of your career. I personally have separate individuals serving as my clinical mentor, my research content mentor, my research methods mentor, my career mentor, and my personal/life mentor. Having multiple mentors allows you to maximize the impact of your different mentors’ strengths across each component of your career. Further, your mentors themselves may have past histories of collaboration that you may then leverage to buoy your own fledgling career. When deciding on who to choose as a mentor, it is important to talk to prior mentees about their experiences with a mentor to help you decide if you may be a good match.
 

Tip #6: Master the art of “Menteering”

Now that you have identified mentors, you need to do your part in nurturing this mentee-mentor relationship. Be an excellent mentee: Show up, stick to a timeline, bring ideas and enthusiasm, and make it easy for your mentor. Your mentors want to see you succeed and sometimes this requires you to help them help you. If you know your own learning style and how you like to interact, have that conversation with your mentor upfront (for example, you may need strict deadlines or you may prefer having more time to develop ideas). Having these conversations before you start a project or a relationship will help set the expectations and ensure effective communication with your mentor. If you find that your mentor is doing something that hinders your progress, such as asking for updates too often or not checking in enough, have a constructive conversation with them about how you feel. Come prepared for meetings with your mentor with an agenda and timeline. Be specific if there is something you need from your mentor and be respectful of their other commitments. For example, if you would like your mentor to review your grant application, let them know the grant deadline and find out when you need to get them a draft so that they will have time to provide meaningful feedback.
 

Tip #7: Identify sponsors

Equally, if not more important than your mentoring team, are sponsors. These are people in positions of power who will promote you and help push your career forward. Sponsors can be people more senior to you, cofellows, or even acquaintances in industry or pharmaceuticals. Your mentor may also be your sponsor, but not always. As early academic faculty, it is important to get your name out there with speaking engagements related to your clinical and research niche, and that is one way a sponsor can help bolster your career.

Tip #8: Develop your personal brand – what is on your T-shirt?

As medicine becomes more and more subspecialized, finding your brand is becoming increasingly important. A brand could be anything from your academic niche to social justice, or even social media utilization. Your brand should encompass what you are naturally excited by within your field. Finding your brand will not only distinguish you from your peers but will also provide you with expertise which you can then offer to your colleagues, near and far. Practice the “elevator pitch” of your personal brand so that you can effectively (and efficiently) describe yourself and your interests when meeting new people and networking.
 

Tip #9: Meet thought leaders in your field

Think of the top five or six most prominent and influential people in your area of clinical or research interest and introduce yourself. This can be done at a national meeting or simply over email, though in person is always best if possible. Although thought leaders are busy, in my experience, if you are persistent, you can always find a few minutes to make an introduction. I’ve shared cab rides just to get a few minutes of someone’s time. In my first few years on faculty, I met with most of the thought leaders in my field; some of these meetings led to fruitful collaborations and important introductions (see tip #7). Meet others at your career level too. They can be great to bounce ideas off, and they will be future leaders in the field. Inviting thought leaders to come to your institution to give talks (in-person or virtually) is another great way to show your interest in their work and also find time to introduce yourself.
 

Tip #10: Apply, apply, apply

Remember that feedback is a gift and the best way to receive feedback is to apply to as many opportunities as you can. Any successful person in GI will have a ‘CV of failures’ far longer than their actual CV documenting their successes. I applied to 8 grants before landing my first one, but I received invaluable feedback and improved my writing skills in the process. Success in fellowship and early faculty takes immense grit – work on building a thick skin and finding the learning opportunity within any outcome.
 

Tip #11: Don’t get sucked into the email abyss

It is easy to fill your time completing low priority, but easy to complete, tasks such as responding to emails. Time management is key and you need to make sure that you dedicate time to more time-consuming tasks – such as writing and developing projects/grants – that have a high reward. Dedicate time on your calendar for high-priority tasks and make sure you don’t open your email during this time. Turn off the email pop-up window and do emails at the end of the day (or whenever you are done writing and thinking). Limiting distractions will help get your creative juices flowing.
 

Tip #12: Don’t always say yes

In fact, don’t ever say yes to a career or research opportunity within the first 24 hours to allow yourself time to weigh the pros and cons of the commitment, to assess the timeline feasibility, and to decide it fits into your 5-year plan. You can say you need to talk to your mentor about it first. If you decide you cannot accept an opportunity, a great way to mitigate that is to simply say “I’d love to, but my mentor says no.” Act as a sponsor to someone else by suggesting a potential colleague who might be interested in the opportunity. As you accept more responsibilities, think about what you might be able to give up to give yourself time to be successful in this new opportunity (and not distract from yourself or your 5-year plan).  
 

Conclusion

Success in research and early academic faculty years takes planning and determination. We hope these tips provide a broad outline for what to think about and how to approach planning your future career. First and foremost, you must put in the time to think about what you really want and what will make you happy in the long run. Academic success is a broad term that each of us defines differently. What does it mean to you? Once you figure that out, make your 5-year plan and run with it!

Dr. Rebello and Dr. Long are with section of gastroenterology at Boston Medical Center and Boston University. They have no conflicts to report.

Congratulations! You have matched in a competitive medical subspecialty or you have secured your first faculty position. But what do you do now? Success in your early career – as a new fellow or a new attending – requires both hard work and perseverance. We present our top 12 tips for how to be successful as you transition into your new position.

Tip #1: Be kind to yourself

As you transition from medical resident to GI fellow or from GI fellow to first-time attending, it is important to recognize that you are going through a major career transition (not as major as fourth year to intern, but probably a close second). First and foremost, remember to be kind to yourself and set reasonable expectations. You need to allow yourself time to transition to a new role which may also be in a new city or state. Take care of yourself – don’t forget to exercise, eat well, and sleep. You are in the long game now. Work to get yourself in a routine that is sustainable. Block out time to exercise, explore your new city, meal plan, and pursue your interests outside of medicine.

Tip #2: Set up for success

Since you are going through this major life/career transition, it is really helpful if you can set yourself up for success by having some projects that are easily completed during this challenging time so that you can demonstrate success. If you have projects in different stages of development, you will always have something you can work on when some projects are delayed for reasons outside of your control. In particular, it is great to have a few papers ready to go during late fellowship so they are published during your first year as an academic attending! This will allow you to continue your research trajectory as you learn the ropes of your new position.

Tip #3: Ask for help

It turns out you cannot do everything on your own! Make sure you are getting help professionally and personally so that you are set up for success. It’s okay to feel overwhelmed or confused; we all do at some point or another. Fellowship and early academic faculty years are stressful and nobody expects you to do it alone. Chances are your mentors or cofellows have had similar struggles, and in opening up, this dialogue may help you both.
 

Tip #4: Write out your 5-year plan

You need to know where you are going before you can figure out how to get there. Take some time for “soul searching”: Think about where you would like to be in 5 years and work backward (along with help from your mentors; see Tip #5) to determine how best to get there. If you think a career in academia might be for you, it’s never too soon to start networking and involving yourself in research. If a specific institution or clinical position draws your attention, check out the current faculty. You can use their CVs as a roadmap of types of experiences and honors that should be on your radar throughout these 5 years. Remember that your 5-year plan is not written in stone – this is something that you should re-evaluate as your interests and priorities change throughout your career.
 

Tip #5: Develop your personal ‘Board of Directors’

Instead of trying to find the perfect mentor, we suggest you seek out a personal “Board of Directors” who can serve as your mentoring team. There will never be a single perfect mentor for you and it is likely that you will need separate mentors to help guide you on different aspects of your career. I personally have separate individuals serving as my clinical mentor, my research content mentor, my research methods mentor, my career mentor, and my personal/life mentor. Having multiple mentors allows you to maximize the impact of your different mentors’ strengths across each component of your career. Further, your mentors themselves may have past histories of collaboration that you may then leverage to buoy your own fledgling career. When deciding on who to choose as a mentor, it is important to talk to prior mentees about their experiences with a mentor to help you decide if you may be a good match.
 

Tip #6: Master the art of “Menteering”

Now that you have identified mentors, you need to do your part in nurturing this mentee-mentor relationship. Be an excellent mentee: Show up, stick to a timeline, bring ideas and enthusiasm, and make it easy for your mentor. Your mentors want to see you succeed and sometimes this requires you to help them help you. If you know your own learning style and how you like to interact, have that conversation with your mentor upfront (for example, you may need strict deadlines or you may prefer having more time to develop ideas). Having these conversations before you start a project or a relationship will help set the expectations and ensure effective communication with your mentor. If you find that your mentor is doing something that hinders your progress, such as asking for updates too often or not checking in enough, have a constructive conversation with them about how you feel. Come prepared for meetings with your mentor with an agenda and timeline. Be specific if there is something you need from your mentor and be respectful of their other commitments. For example, if you would like your mentor to review your grant application, let them know the grant deadline and find out when you need to get them a draft so that they will have time to provide meaningful feedback.
 

Tip #7: Identify sponsors

Equally, if not more important than your mentoring team, are sponsors. These are people in positions of power who will promote you and help push your career forward. Sponsors can be people more senior to you, cofellows, or even acquaintances in industry or pharmaceuticals. Your mentor may also be your sponsor, but not always. As early academic faculty, it is important to get your name out there with speaking engagements related to your clinical and research niche, and that is one way a sponsor can help bolster your career.

Tip #8: Develop your personal brand – what is on your T-shirt?

As medicine becomes more and more subspecialized, finding your brand is becoming increasingly important. A brand could be anything from your academic niche to social justice, or even social media utilization. Your brand should encompass what you are naturally excited by within your field. Finding your brand will not only distinguish you from your peers but will also provide you with expertise which you can then offer to your colleagues, near and far. Practice the “elevator pitch” of your personal brand so that you can effectively (and efficiently) describe yourself and your interests when meeting new people and networking.
 

Tip #9: Meet thought leaders in your field

Think of the top five or six most prominent and influential people in your area of clinical or research interest and introduce yourself. This can be done at a national meeting or simply over email, though in person is always best if possible. Although thought leaders are busy, in my experience, if you are persistent, you can always find a few minutes to make an introduction. I’ve shared cab rides just to get a few minutes of someone’s time. In my first few years on faculty, I met with most of the thought leaders in my field; some of these meetings led to fruitful collaborations and important introductions (see tip #7). Meet others at your career level too. They can be great to bounce ideas off, and they will be future leaders in the field. Inviting thought leaders to come to your institution to give talks (in-person or virtually) is another great way to show your interest in their work and also find time to introduce yourself.
 

Tip #10: Apply, apply, apply

Remember that feedback is a gift and the best way to receive feedback is to apply to as many opportunities as you can. Any successful person in GI will have a ‘CV of failures’ far longer than their actual CV documenting their successes. I applied to 8 grants before landing my first one, but I received invaluable feedback and improved my writing skills in the process. Success in fellowship and early faculty takes immense grit – work on building a thick skin and finding the learning opportunity within any outcome.
 

Tip #11: Don’t get sucked into the email abyss

It is easy to fill your time completing low priority, but easy to complete, tasks such as responding to emails. Time management is key and you need to make sure that you dedicate time to more time-consuming tasks – such as writing and developing projects/grants – that have a high reward. Dedicate time on your calendar for high-priority tasks and make sure you don’t open your email during this time. Turn off the email pop-up window and do emails at the end of the day (or whenever you are done writing and thinking). Limiting distractions will help get your creative juices flowing.
 

Tip #12: Don’t always say yes

In fact, don’t ever say yes to a career or research opportunity within the first 24 hours to allow yourself time to weigh the pros and cons of the commitment, to assess the timeline feasibility, and to decide it fits into your 5-year plan. You can say you need to talk to your mentor about it first. If you decide you cannot accept an opportunity, a great way to mitigate that is to simply say “I’d love to, but my mentor says no.” Act as a sponsor to someone else by suggesting a potential colleague who might be interested in the opportunity. As you accept more responsibilities, think about what you might be able to give up to give yourself time to be successful in this new opportunity (and not distract from yourself or your 5-year plan).  
 

Conclusion

Success in research and early academic faculty years takes planning and determination. We hope these tips provide a broad outline for what to think about and how to approach planning your future career. First and foremost, you must put in the time to think about what you really want and what will make you happy in the long run. Academic success is a broad term that each of us defines differently. What does it mean to you? Once you figure that out, make your 5-year plan and run with it!

Dr. Rebello and Dr. Long are with section of gastroenterology at Boston Medical Center and Boston University. They have no conflicts to report.

Malignancy rates were low in patients with psoriasis, psoriatic arthritis (PsA), and ankylosing spondylitis who were treated with secukinumab, for up to 5 years, based on data from a safety analysis that included 49 clinical trials.

Secukinumab (Cosentyx), an interleukin-17A antagonist, is approved for several conditions: moderate to severe psoriasis in children and adults, PsA, ankylosing spondylitis (AS), and nonradiographic axial spondyloarthritis.

Although secukinumab has demonstrated safety and tolerability, data on long-term malignancy rates are limited, wrote Mark Lebwohl, MD, professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York, and coauthors.

In a study published in the British Journal of Dermatology, they analyzed the combined safety data from clinical trials and postmarketing surveillance. The study population included 10,685 patients with psoriasis, 2,523 patients with PsA, and 1,311 patients with ankylosing spondylitis who received at least one approved dose of secukinumab (300 mg or 150 mg). The maximum follow-up was 5 years. The exposure-adjusted incidence rate was defined as the incidence rates per 100 patient treatment-years (PTY). The cumulative exposure for patients with psoriasis, PsA, and AS was 16,482, 4,944, and 2,668 PTY, respectively, with average follow-up times of 1.54, 1.96, and 2.03 years, respectively.

The observed and the expected number of malignancies were comparable, with a standardized incidence ratio (SIR) for malignancy of 0.99 across all treatment indications, the researchers said. In further analysis of malignancy by indication, the SIR was 0.87, 1.16, and 1.61 for psoriasis, PsA, and AS, respectively.

Data from postmarketing surveillance showed similar results: The estimated crude cumulative incidence reporting rate per 100 PTY was 0.27 for malignancy across all indications. The cumulative exposure was 285,811 PTY.

The study findings were limited by several factors including the post hoc design, differences in clinical trial methodologies, and lack of controlling for confounding variables, such as smoking status and previous exposure to systemic and biologic treatments, the researchers noted. In addition, the analysis did not include postexposure follow-up data, or data on patients who discontinued clinical trials, they said.

Overall, the analysis is the largest to date and supports the low risk of malignancy in patients with psoriasis, PsA, and AS treated with secukinumab, the researchers noted.

However, “while this assessment provides a broader understanding of the safety of secukinumab and supports its long-term use in these chronic systemic inflammatory conditions, registry data are further warranted to fully understand the real-world effect of biologics on malignancy risk,” they concluded.

“Secukinumab is a relatively newer biologic, approved in 2015, and there is currently a lack of longer-term data on the incidence of malignancy in secukinumab-treated patients, so it’s important to look at the data we have so far on this topic so we can better understand the long-term risks and counsel our psoriasis and psoriatic arthritis patients,” Flavia Fedeles, MD, of the department of dermatology at Massachusetts General Hospital, Boston, said in an interview.

Dr. Fedeles, who was not involved with the study, said that she was not surprised by the study results. “Data reported in the past from phase 3 clinical trials of secukinumab compared with placebo did not show an increase in risk of malignancy, though at that time no long-term safety data or data from patients with history of malignancy was available,” she said. “This study is reassuring in that there wasn’t a signal of increased malignancy events up to 5 years of secukinumab treatment,” said Dr. Fedeles.

Malignancy rates were low in patients with psoriasis, psoriatic arthritis (PsA), and ankylosing spondylitis who were treated with secukinumab, for up to 5 years, based on data from a safety analysis that included 49 clinical trials.

Secukinumab (Cosentyx), an interleukin-17A antagonist, is approved for several conditions: moderate to severe psoriasis in children and adults, PsA, ankylosing spondylitis (AS), and nonradiographic axial spondyloarthritis.

Although secukinumab has demonstrated safety and tolerability, data on long-term malignancy rates are limited, wrote Mark Lebwohl, MD, professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York, and coauthors.

In a study published in the British Journal of Dermatology, they analyzed the combined safety data from clinical trials and postmarketing surveillance. The study population included 10,685 patients with psoriasis, 2,523 patients with PsA, and 1,311 patients with ankylosing spondylitis who received at least one approved dose of secukinumab (300 mg or 150 mg). The maximum follow-up was 5 years. The exposure-adjusted incidence rate was defined as the incidence rates per 100 patient treatment-years (PTY). The cumulative exposure for patients with psoriasis, PsA, and AS was 16,482, 4,944, and 2,668 PTY, respectively, with average follow-up times of 1.54, 1.96, and 2.03 years, respectively.

The observed and the expected number of malignancies were comparable, with a standardized incidence ratio (SIR) for malignancy of 0.99 across all treatment indications, the researchers said. In further analysis of malignancy by indication, the SIR was 0.87, 1.16, and 1.61 for psoriasis, PsA, and AS, respectively.

Data from postmarketing surveillance showed similar results: The estimated crude cumulative incidence reporting rate per 100 PTY was 0.27 for malignancy across all indications. The cumulative exposure was 285,811 PTY.

The study findings were limited by several factors including the post hoc design, differences in clinical trial methodologies, and lack of controlling for confounding variables, such as smoking status and previous exposure to systemic and biologic treatments, the researchers noted. In addition, the analysis did not include postexposure follow-up data, or data on patients who discontinued clinical trials, they said.

Overall, the analysis is the largest to date and supports the low risk of malignancy in patients with psoriasis, PsA, and AS treated with secukinumab, the researchers noted.

However, “while this assessment provides a broader understanding of the safety of secukinumab and supports its long-term use in these chronic systemic inflammatory conditions, registry data are further warranted to fully understand the real-world effect of biologics on malignancy risk,” they concluded.

“Secukinumab is a relatively newer biologic, approved in 2015, and there is currently a lack of longer-term data on the incidence of malignancy in secukinumab-treated patients, so it’s important to look at the data we have so far on this topic so we can better understand the long-term risks and counsel our psoriasis and psoriatic arthritis patients,” Flavia Fedeles, MD, of the department of dermatology at Massachusetts General Hospital, Boston, said in an interview.

Dr. Fedeles, who was not involved with the study, said that she was not surprised by the study results. “Data reported in the past from phase 3 clinical trials of secukinumab compared with placebo did not show an increase in risk of malignancy, though at that time no long-term safety data or data from patients with history of malignancy was available,” she said. “This study is reassuring in that there wasn’t a signal of increased malignancy events up to 5 years of secukinumab treatment,” said Dr. Fedeles.

Malignancy rates were low in patients with psoriasis, psoriatic arthritis (PsA), and ankylosing spondylitis who were treated with secukinumab, for up to 5 years, based on data from a safety analysis that included 49 clinical trials.

Secukinumab (Cosentyx), an interleukin-17A antagonist, is approved for several conditions: moderate to severe psoriasis in children and adults, PsA, ankylosing spondylitis (AS), and nonradiographic axial spondyloarthritis.

Although secukinumab has demonstrated safety and tolerability, data on long-term malignancy rates are limited, wrote Mark Lebwohl, MD, professor of dermatology at the Icahn School of Medicine at Mount Sinai, New York, and coauthors.

In a study published in the British Journal of Dermatology, they analyzed the combined safety data from clinical trials and postmarketing surveillance. The study population included 10,685 patients with psoriasis, 2,523 patients with PsA, and 1,311 patients with ankylosing spondylitis who received at least one approved dose of secukinumab (300 mg or 150 mg). The maximum follow-up was 5 years. The exposure-adjusted incidence rate was defined as the incidence rates per 100 patient treatment-years (PTY). The cumulative exposure for patients with psoriasis, PsA, and AS was 16,482, 4,944, and 2,668 PTY, respectively, with average follow-up times of 1.54, 1.96, and 2.03 years, respectively.

The observed and the expected number of malignancies were comparable, with a standardized incidence ratio (SIR) for malignancy of 0.99 across all treatment indications, the researchers said. In further analysis of malignancy by indication, the SIR was 0.87, 1.16, and 1.61 for psoriasis, PsA, and AS, respectively.

Data from postmarketing surveillance showed similar results: The estimated crude cumulative incidence reporting rate per 100 PTY was 0.27 for malignancy across all indications. The cumulative exposure was 285,811 PTY.

The study findings were limited by several factors including the post hoc design, differences in clinical trial methodologies, and lack of controlling for confounding variables, such as smoking status and previous exposure to systemic and biologic treatments, the researchers noted. In addition, the analysis did not include postexposure follow-up data, or data on patients who discontinued clinical trials, they said.

Overall, the analysis is the largest to date and supports the low risk of malignancy in patients with psoriasis, PsA, and AS treated with secukinumab, the researchers noted.

However, “while this assessment provides a broader understanding of the safety of secukinumab and supports its long-term use in these chronic systemic inflammatory conditions, registry data are further warranted to fully understand the real-world effect of biologics on malignancy risk,” they concluded.

“Secukinumab is a relatively newer biologic, approved in 2015, and there is currently a lack of longer-term data on the incidence of malignancy in secukinumab-treated patients, so it’s important to look at the data we have so far on this topic so we can better understand the long-term risks and counsel our psoriasis and psoriatic arthritis patients,” Flavia Fedeles, MD, of the department of dermatology at Massachusetts General Hospital, Boston, said in an interview.

Dr. Fedeles, who was not involved with the study, said that she was not surprised by the study results. “Data reported in the past from phase 3 clinical trials of secukinumab compared with placebo did not show an increase in risk of malignancy, though at that time no long-term safety data or data from patients with history of malignancy was available,” she said. “This study is reassuring in that there wasn’t a signal of increased malignancy events up to 5 years of secukinumab treatment,” said Dr. Fedeles.