The world’s premier meeting for gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals will be a fully virtual event, May 21-23, 2021. We invite you to take advantage of this unique opportunity to exchange knowledge with colleagues from all over the world and explore the latest advances in the field – all from the convenience of your home. Plus, your registration grants you access to everything offered at Digestive Disease Week® (DDW) this year (no additional ticketed sessions). Learn more and register at ddw.org.

The world’s premier meeting for gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals will be a fully virtual event, May 21-23, 2021. We invite you to take advantage of this unique opportunity to exchange knowledge with colleagues from all over the world and explore the latest advances in the field – all from the convenience of your home. Plus, your registration grants you access to everything offered at Digestive Disease Week® (DDW) this year (no additional ticketed sessions). Learn more and register at ddw.org.

The world’s premier meeting for gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals will be a fully virtual event, May 21-23, 2021. We invite you to take advantage of this unique opportunity to exchange knowledge with colleagues from all over the world and explore the latest advances in the field – all from the convenience of your home. Plus, your registration grants you access to everything offered at Digestive Disease Week® (DDW) this year (no additional ticketed sessions). Learn more and register at ddw.org.

The AGA Institute Clinical Guidelines Committee wants your input on the next set of guidelines to be developed. By completing an online form, you can submit recommendations for guideline topics that will be developed within the next two years. The deadline to submit your ideas is Monday, May 3.

It’s as easy as three steps to submit a guideline idea

• Check out the guidelines that AGA has already developed or are in progress.
• Complete the survey below. You can submit more than one guideline topic by filling out the form multiple times.
• Stay tuned for follow up questions in case the committee needs more information on your recommendations.

The AGA Institute Clinical Guidelines Committee will review guideline topics in May, prioritizing and ranking topics based on the following criteria: prevalence of disease, resource utilization, variation in care, other existing guidelines, new data/changes in diagnosis or treatment, and potential for measure/quality development. Once vetted, four or more new guidelines will be recommended for development throughout the year. Complete the online survey at www.surveymonkey.com/r/AGAtopicsubmission

The AGA Institute Clinical Guidelines Committee wants your input on the next set of guidelines to be developed. By completing an online form, you can submit recommendations for guideline topics that will be developed within the next two years. The deadline to submit your ideas is Monday, May 3.

It’s as easy as three steps to submit a guideline idea

• Check out the guidelines that AGA has already developed or are in progress.
• Complete the survey below. You can submit more than one guideline topic by filling out the form multiple times.
• Stay tuned for follow up questions in case the committee needs more information on your recommendations.

The AGA Institute Clinical Guidelines Committee will review guideline topics in May, prioritizing and ranking topics based on the following criteria: prevalence of disease, resource utilization, variation in care, other existing guidelines, new data/changes in diagnosis or treatment, and potential for measure/quality development. Once vetted, four or more new guidelines will be recommended for development throughout the year. Complete the online survey at www.surveymonkey.com/r/AGAtopicsubmission

The AGA Institute Clinical Guidelines Committee wants your input on the next set of guidelines to be developed. By completing an online form, you can submit recommendations for guideline topics that will be developed within the next two years. The deadline to submit your ideas is Monday, May 3.

It’s as easy as three steps to submit a guideline idea

• Check out the guidelines that AGA has already developed or are in progress.
• Complete the survey below. You can submit more than one guideline topic by filling out the form multiple times.
• Stay tuned for follow up questions in case the committee needs more information on your recommendations.

The AGA Institute Clinical Guidelines Committee will review guideline topics in May, prioritizing and ranking topics based on the following criteria: prevalence of disease, resource utilization, variation in care, other existing guidelines, new data/changes in diagnosis or treatment, and potential for measure/quality development. Once vetted, four or more new guidelines will be recommended for development throughout the year. Complete the online survey at www.surveymonkey.com/r/AGAtopicsubmission

Around three-quarters of patients remained on treatment with baricitinib (Olumiant) for rheumatoid arthritis after their first 6-month assessment in an independent analysis of British Society for Rheumatology Biologics Register (BSRBR) data.

The rate of continuation was even higher, at almost 85%, in patients who had not previously been treated with a biologic or targeted synthetic disease-modifying antirheumatic drug (b/ts DMARD) before being given baricitinib. The 6-month continuation rate was also higher, at 80%, in patients who received baricitinib without additional DMARDs or steroid therapy.

Overall, the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) score was reduced from a baseline of 5.7 to 3.4, with similar reductions seen among the subgroups of patients who had received baricitinib as monotherapy, after prior b/tsDMARDs, or no prior b/tsDMARDs.

“We’ve looked at an RA study population using data from the BSR biologics registry, to try and have a look at how patients with baricitinib are being treated and how they’re doing in this real-world setting, within the U.K.,” explained consultant rheumatologist Christopher J. Edwards, MD, of University Hospital Southampton (England) at the British Society for Rheumatology annual conference.

“Overall, effectiveness and tolerability seem to be pretty good indeed,” he said. “Sample size, of course, was small and it will be nice to see a little bit more data collected over time that allow us to be more confident in any conclusions.”

‘Getting to grips’ with baricitinib

Baricitinib is a drug that clinicians in the United Kingdom are “just getting to grips with,” observed Jon Packham, BM, DM, a consultant rheumatologist at Haywood Hospital in Stoke-on-Trent (England) who was not involved in the analysis.

“We look forward to when we’ve got a few more patients through that 6-month hurdle and we were getting even more data coming through,” Dr. Packham said.

Baricitinib was given marketing authorization in Europe for the treatment of moderate to severe RA in 2017 and so is a relatively new addition into the BSRBR-RA, which has been running for the past 20 years. It includes data on patients with RA who are newly starting a bDMARD or tsDMARD, and patients are followed up every 6 months for the first 3 years of their treatment and then annually thereafter.

Dr. Edwards presented data on some of the baseline characteristics and status of patients at the first 6-month follow-up of the BSRBR-RA. He was clear that this analysis was done independently of the BSRBR-RA study team and performed under an agreement between Eli Lilly and the BSR to allow access to the data.

Between Jan. 1, 2018, and March 31, 2019, there were 409 patients who were just starting baricitinib treatment and who were entered into the BSRBR-RA. The mean age of patients was 61 years, and the majority (76%) was female. On average, patients starting baricitinib had been diagnosed with RA for 11 years, and 62% had previously been treated with a biologic.

As per the European label, most patients were being treated with baricitinib in combination with a conventional synthetic DMARD (61%), with 40% of patients receiving it in combination with methotrexate. Around 38% of patients received baricitinib as monotherapy, and just under 30% were receiving concomitant glucocorticoids.

The majority (84%) were prescribed a 4-mg daily dose of baricitinib, with the remainder on a daily dose of 2 mg.

There were 163 patients with data available at the first 6-month follow up, and of those, 103 had prior experience of being treated with a b/ts DMARD, 59 did not, and 65 had been given baricitinib as monotherapy.
 

Reasons for discontinuation

Overall, around a quarter of patients discontinued treatment with baricitinib, and “the reasons for this were lack of efficacy in approximately a quarter and adverse events in about two-thirds of the patients,” Dr. Edwards said.

Breaking down the types of adverse events was not part of this analysis, and that information is likely to come from the BSRBR-RA study team directly.

“We have some experience in our practice in Southampton,” Dr. Edwards observed. This experience was outlined in a separate abstract at the meeting and presented by Dr. May Nwe Lwin, a clinical research fellow within Dr. Edwards’ group.

Dr. Lwin presented data on 83 patients who had received baricitinib at University Hospital Southampton between October 2017 and July 2020, 55 (65.2%) of whom remain on treatment to date, with mean follow-up of 17 months. Of the 28 patients who stopped baricitinib, 21 stopped within 12 months.

“Patients who continued on baricitinib appeared more likely to be older and female,” Dr. Lwin said.

The mean age of patients who continued on treatment after 12 months was 61.5 years but was 49 years for those who stopped earlier. The percentage of women continuing treatment at 12 months versus those stopping earlier were a respective 82% and 67%. Both findings were significant (P < .001) but “could mean nothing, or could be very interesting data to explore more,” Dr. Lwin suggested.

“However, there was no significant difference in discontinuation rates for those using mono or combination therapy, and also no effect of disease duration or seropositivity,” Dr. Lwin said.

“Most people stopped baricitinib in the first 3 months of their treatment,” Dr. Lwin reported, noting that the most common reason was a lack of efficacy in 64% of patients, with 28.5% of patients discontinuing because of side effects.

“When you look at the adverse events, the reasons for discontinuation are quite variable,” Dr. Lwin said. These included infections (one urinary tract infection, two chest infections, and a urinary tract infection), and one case each of discitis, deranged liver function, lymphoma, and personality change.

Update on the long-term safety profile

Also at the BSR annual conference, an update on the long-term safety profile of baricitinib seen in clinical trials was presented, using data from the ‘All-BARI-RA’ dataset. This includes data from nine clinical trials and one long-term extension study.

“We recently published a long-term safety analysis of this molecule involving 3,700-plus patients with exposure up to 7 years,” said Kevin L. Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health Sciences University in Portland.

Dr. Winthrop provided an update on this, adding in another 13,148 patient-years of follow-up and giving data on the safety experience with baricitinib with up to 8.4 years of exposure for some patients.

“In short, not much has changed,” Dr. Winthrop said, noting that event rates have remained stable.

The overall major adverse cardiovascular event (MACE) and overall deep vein thrombosis/pulmonary embolism event rate were both 0.5 per 100 patient-years. Referring to the latter, Dr. Winthrop called them “rock solid stable” and “it’s been that way really all the way through the development program.”

Overall, event rates per 100 patient-years for serious infections, herpes zoster, and tuberculosis were a respective 2.7, 3.0, and 0.2. Serious infection rates over time have remained similar, but “clearly age is a risk factor for infection,” Dr. Winthrop said. “I would just say it’s similar to what we see with all biologics and small molecules in this setting.”

Malignancy and death rates were also higher in older patients, but after age adjustment, these had been stable across the different analysis points.

“Malignancy overall, excluding NMSC [nonmelanoma skin cancer], the event rate is 0.9 per 100 patient-years, very similar to what we’ve seen in the prior data cuts,” he said. “The same is true for lymphoma,” he added, with an overall event rate of 0.1 per 100 patient-years.

This updated analysis, Dr. Winthrop concluded, “suggests a safety profile really very similar to what was published recently.”Dr. Edwards has received research and educational grants and advisory panel and speaker fees from Eli Lilly and from multiple other pharmaceutical companies. The analysis of BSRBR-RA data he presented was sponsored by Eli Lilly and performed independently of the BSRBR-RA study team. Dr. Packham reported no conflicts of interest; he chaired the oral abstracts sessions in which Dr. Edwards presented his findings.

Dr. Lwin did not report having any disclosures.

Dr. Winthrop has acted as a consultant to Eli Lilly and several other pharmaceutical companies and had received research or grant support from Bristol-Myers Squibb and Pfizer. The work he presented was sponsored by Eli Lilly.

Around three-quarters of patients remained on treatment with baricitinib (Olumiant) for rheumatoid arthritis after their first 6-month assessment in an independent analysis of British Society for Rheumatology Biologics Register (BSRBR) data.

The rate of continuation was even higher, at almost 85%, in patients who had not previously been treated with a biologic or targeted synthetic disease-modifying antirheumatic drug (b/ts DMARD) before being given baricitinib. The 6-month continuation rate was also higher, at 80%, in patients who received baricitinib without additional DMARDs or steroid therapy.

Overall, the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) score was reduced from a baseline of 5.7 to 3.4, with similar reductions seen among the subgroups of patients who had received baricitinib as monotherapy, after prior b/tsDMARDs, or no prior b/tsDMARDs.

“We’ve looked at an RA study population using data from the BSR biologics registry, to try and have a look at how patients with baricitinib are being treated and how they’re doing in this real-world setting, within the U.K.,” explained consultant rheumatologist Christopher J. Edwards, MD, of University Hospital Southampton (England) at the British Society for Rheumatology annual conference.

“Overall, effectiveness and tolerability seem to be pretty good indeed,” he said. “Sample size, of course, was small and it will be nice to see a little bit more data collected over time that allow us to be more confident in any conclusions.”

‘Getting to grips’ with baricitinib

Baricitinib is a drug that clinicians in the United Kingdom are “just getting to grips with,” observed Jon Packham, BM, DM, a consultant rheumatologist at Haywood Hospital in Stoke-on-Trent (England) who was not involved in the analysis.

“We look forward to when we’ve got a few more patients through that 6-month hurdle and we were getting even more data coming through,” Dr. Packham said.

Baricitinib was given marketing authorization in Europe for the treatment of moderate to severe RA in 2017 and so is a relatively new addition into the BSRBR-RA, which has been running for the past 20 years. It includes data on patients with RA who are newly starting a bDMARD or tsDMARD, and patients are followed up every 6 months for the first 3 years of their treatment and then annually thereafter.

Dr. Edwards presented data on some of the baseline characteristics and status of patients at the first 6-month follow-up of the BSRBR-RA. He was clear that this analysis was done independently of the BSRBR-RA study team and performed under an agreement between Eli Lilly and the BSR to allow access to the data.

Between Jan. 1, 2018, and March 31, 2019, there were 409 patients who were just starting baricitinib treatment and who were entered into the BSRBR-RA. The mean age of patients was 61 years, and the majority (76%) was female. On average, patients starting baricitinib had been diagnosed with RA for 11 years, and 62% had previously been treated with a biologic.

As per the European label, most patients were being treated with baricitinib in combination with a conventional synthetic DMARD (61%), with 40% of patients receiving it in combination with methotrexate. Around 38% of patients received baricitinib as monotherapy, and just under 30% were receiving concomitant glucocorticoids.

The majority (84%) were prescribed a 4-mg daily dose of baricitinib, with the remainder on a daily dose of 2 mg.

There were 163 patients with data available at the first 6-month follow up, and of those, 103 had prior experience of being treated with a b/ts DMARD, 59 did not, and 65 had been given baricitinib as monotherapy.
 

Reasons for discontinuation

Overall, around a quarter of patients discontinued treatment with baricitinib, and “the reasons for this were lack of efficacy in approximately a quarter and adverse events in about two-thirds of the patients,” Dr. Edwards said.

Breaking down the types of adverse events was not part of this analysis, and that information is likely to come from the BSRBR-RA study team directly.

“We have some experience in our practice in Southampton,” Dr. Edwards observed. This experience was outlined in a separate abstract at the meeting and presented by Dr. May Nwe Lwin, a clinical research fellow within Dr. Edwards’ group.

Dr. Lwin presented data on 83 patients who had received baricitinib at University Hospital Southampton between October 2017 and July 2020, 55 (65.2%) of whom remain on treatment to date, with mean follow-up of 17 months. Of the 28 patients who stopped baricitinib, 21 stopped within 12 months.

“Patients who continued on baricitinib appeared more likely to be older and female,” Dr. Lwin said.

The mean age of patients who continued on treatment after 12 months was 61.5 years but was 49 years for those who stopped earlier. The percentage of women continuing treatment at 12 months versus those stopping earlier were a respective 82% and 67%. Both findings were significant (P < .001) but “could mean nothing, or could be very interesting data to explore more,” Dr. Lwin suggested.

“However, there was no significant difference in discontinuation rates for those using mono or combination therapy, and also no effect of disease duration or seropositivity,” Dr. Lwin said.

“Most people stopped baricitinib in the first 3 months of their treatment,” Dr. Lwin reported, noting that the most common reason was a lack of efficacy in 64% of patients, with 28.5% of patients discontinuing because of side effects.

“When you look at the adverse events, the reasons for discontinuation are quite variable,” Dr. Lwin said. These included infections (one urinary tract infection, two chest infections, and a urinary tract infection), and one case each of discitis, deranged liver function, lymphoma, and personality change.

Update on the long-term safety profile

Also at the BSR annual conference, an update on the long-term safety profile of baricitinib seen in clinical trials was presented, using data from the ‘All-BARI-RA’ dataset. This includes data from nine clinical trials and one long-term extension study.

“We recently published a long-term safety analysis of this molecule involving 3,700-plus patients with exposure up to 7 years,” said Kevin L. Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health Sciences University in Portland.

Dr. Winthrop provided an update on this, adding in another 13,148 patient-years of follow-up and giving data on the safety experience with baricitinib with up to 8.4 years of exposure for some patients.

“In short, not much has changed,” Dr. Winthrop said, noting that event rates have remained stable.

The overall major adverse cardiovascular event (MACE) and overall deep vein thrombosis/pulmonary embolism event rate were both 0.5 per 100 patient-years. Referring to the latter, Dr. Winthrop called them “rock solid stable” and “it’s been that way really all the way through the development program.”

Overall, event rates per 100 patient-years for serious infections, herpes zoster, and tuberculosis were a respective 2.7, 3.0, and 0.2. Serious infection rates over time have remained similar, but “clearly age is a risk factor for infection,” Dr. Winthrop said. “I would just say it’s similar to what we see with all biologics and small molecules in this setting.”

Malignancy and death rates were also higher in older patients, but after age adjustment, these had been stable across the different analysis points.

“Malignancy overall, excluding NMSC [nonmelanoma skin cancer], the event rate is 0.9 per 100 patient-years, very similar to what we’ve seen in the prior data cuts,” he said. “The same is true for lymphoma,” he added, with an overall event rate of 0.1 per 100 patient-years.

This updated analysis, Dr. Winthrop concluded, “suggests a safety profile really very similar to what was published recently.”Dr. Edwards has received research and educational grants and advisory panel and speaker fees from Eli Lilly and from multiple other pharmaceutical companies. The analysis of BSRBR-RA data he presented was sponsored by Eli Lilly and performed independently of the BSRBR-RA study team. Dr. Packham reported no conflicts of interest; he chaired the oral abstracts sessions in which Dr. Edwards presented his findings.

Dr. Lwin did not report having any disclosures.

Dr. Winthrop has acted as a consultant to Eli Lilly and several other pharmaceutical companies and had received research or grant support from Bristol-Myers Squibb and Pfizer. The work he presented was sponsored by Eli Lilly.

Around three-quarters of patients remained on treatment with baricitinib (Olumiant) for rheumatoid arthritis after their first 6-month assessment in an independent analysis of British Society for Rheumatology Biologics Register (BSRBR) data.

The rate of continuation was even higher, at almost 85%, in patients who had not previously been treated with a biologic or targeted synthetic disease-modifying antirheumatic drug (b/ts DMARD) before being given baricitinib. The 6-month continuation rate was also higher, at 80%, in patients who received baricitinib without additional DMARDs or steroid therapy.

Overall, the Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR) score was reduced from a baseline of 5.7 to 3.4, with similar reductions seen among the subgroups of patients who had received baricitinib as monotherapy, after prior b/tsDMARDs, or no prior b/tsDMARDs.

“We’ve looked at an RA study population using data from the BSR biologics registry, to try and have a look at how patients with baricitinib are being treated and how they’re doing in this real-world setting, within the U.K.,” explained consultant rheumatologist Christopher J. Edwards, MD, of University Hospital Southampton (England) at the British Society for Rheumatology annual conference.

“Overall, effectiveness and tolerability seem to be pretty good indeed,” he said. “Sample size, of course, was small and it will be nice to see a little bit more data collected over time that allow us to be more confident in any conclusions.”

‘Getting to grips’ with baricitinib

Baricitinib is a drug that clinicians in the United Kingdom are “just getting to grips with,” observed Jon Packham, BM, DM, a consultant rheumatologist at Haywood Hospital in Stoke-on-Trent (England) who was not involved in the analysis.

“We look forward to when we’ve got a few more patients through that 6-month hurdle and we were getting even more data coming through,” Dr. Packham said.

Baricitinib was given marketing authorization in Europe for the treatment of moderate to severe RA in 2017 and so is a relatively new addition into the BSRBR-RA, which has been running for the past 20 years. It includes data on patients with RA who are newly starting a bDMARD or tsDMARD, and patients are followed up every 6 months for the first 3 years of their treatment and then annually thereafter.

Dr. Edwards presented data on some of the baseline characteristics and status of patients at the first 6-month follow-up of the BSRBR-RA. He was clear that this analysis was done independently of the BSRBR-RA study team and performed under an agreement between Eli Lilly and the BSR to allow access to the data.

Between Jan. 1, 2018, and March 31, 2019, there were 409 patients who were just starting baricitinib treatment and who were entered into the BSRBR-RA. The mean age of patients was 61 years, and the majority (76%) was female. On average, patients starting baricitinib had been diagnosed with RA for 11 years, and 62% had previously been treated with a biologic.

As per the European label, most patients were being treated with baricitinib in combination with a conventional synthetic DMARD (61%), with 40% of patients receiving it in combination with methotrexate. Around 38% of patients received baricitinib as monotherapy, and just under 30% were receiving concomitant glucocorticoids.

The majority (84%) were prescribed a 4-mg daily dose of baricitinib, with the remainder on a daily dose of 2 mg.

There were 163 patients with data available at the first 6-month follow up, and of those, 103 had prior experience of being treated with a b/ts DMARD, 59 did not, and 65 had been given baricitinib as monotherapy.
 

Reasons for discontinuation

Overall, around a quarter of patients discontinued treatment with baricitinib, and “the reasons for this were lack of efficacy in approximately a quarter and adverse events in about two-thirds of the patients,” Dr. Edwards said.

Breaking down the types of adverse events was not part of this analysis, and that information is likely to come from the BSRBR-RA study team directly.

“We have some experience in our practice in Southampton,” Dr. Edwards observed. This experience was outlined in a separate abstract at the meeting and presented by Dr. May Nwe Lwin, a clinical research fellow within Dr. Edwards’ group.

Dr. Lwin presented data on 83 patients who had received baricitinib at University Hospital Southampton between October 2017 and July 2020, 55 (65.2%) of whom remain on treatment to date, with mean follow-up of 17 months. Of the 28 patients who stopped baricitinib, 21 stopped within 12 months.

“Patients who continued on baricitinib appeared more likely to be older and female,” Dr. Lwin said.

The mean age of patients who continued on treatment after 12 months was 61.5 years but was 49 years for those who stopped earlier. The percentage of women continuing treatment at 12 months versus those stopping earlier were a respective 82% and 67%. Both findings were significant (P < .001) but “could mean nothing, or could be very interesting data to explore more,” Dr. Lwin suggested.

“However, there was no significant difference in discontinuation rates for those using mono or combination therapy, and also no effect of disease duration or seropositivity,” Dr. Lwin said.

“Most people stopped baricitinib in the first 3 months of their treatment,” Dr. Lwin reported, noting that the most common reason was a lack of efficacy in 64% of patients, with 28.5% of patients discontinuing because of side effects.

“When you look at the adverse events, the reasons for discontinuation are quite variable,” Dr. Lwin said. These included infections (one urinary tract infection, two chest infections, and a urinary tract infection), and one case each of discitis, deranged liver function, lymphoma, and personality change.

Update on the long-term safety profile

Also at the BSR annual conference, an update on the long-term safety profile of baricitinib seen in clinical trials was presented, using data from the ‘All-BARI-RA’ dataset. This includes data from nine clinical trials and one long-term extension study.

“We recently published a long-term safety analysis of this molecule involving 3,700-plus patients with exposure up to 7 years,” said Kevin L. Winthrop, MD, MPH, professor of infectious diseases and epidemiology at Oregon Health Sciences University in Portland.

Dr. Winthrop provided an update on this, adding in another 13,148 patient-years of follow-up and giving data on the safety experience with baricitinib with up to 8.4 years of exposure for some patients.

“In short, not much has changed,” Dr. Winthrop said, noting that event rates have remained stable.

The overall major adverse cardiovascular event (MACE) and overall deep vein thrombosis/pulmonary embolism event rate were both 0.5 per 100 patient-years. Referring to the latter, Dr. Winthrop called them “rock solid stable” and “it’s been that way really all the way through the development program.”

Overall, event rates per 100 patient-years for serious infections, herpes zoster, and tuberculosis were a respective 2.7, 3.0, and 0.2. Serious infection rates over time have remained similar, but “clearly age is a risk factor for infection,” Dr. Winthrop said. “I would just say it’s similar to what we see with all biologics and small molecules in this setting.”

Malignancy and death rates were also higher in older patients, but after age adjustment, these had been stable across the different analysis points.

“Malignancy overall, excluding NMSC [nonmelanoma skin cancer], the event rate is 0.9 per 100 patient-years, very similar to what we’ve seen in the prior data cuts,” he said. “The same is true for lymphoma,” he added, with an overall event rate of 0.1 per 100 patient-years.

This updated analysis, Dr. Winthrop concluded, “suggests a safety profile really very similar to what was published recently.”Dr. Edwards has received research and educational grants and advisory panel and speaker fees from Eli Lilly and from multiple other pharmaceutical companies. The analysis of BSRBR-RA data he presented was sponsored by Eli Lilly and performed independently of the BSRBR-RA study team. Dr. Packham reported no conflicts of interest; he chaired the oral abstracts sessions in which Dr. Edwards presented his findings.

Dr. Lwin did not report having any disclosures.

Dr. Winthrop has acted as a consultant to Eli Lilly and several other pharmaceutical companies and had received research or grant support from Bristol-Myers Squibb and Pfizer. The work he presented was sponsored by Eli Lilly.

Applications are now open for the 2022 AGA Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education or research (basic or clinical) are encouraged to apply today.

Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:

• The privilege of using the designation “AGAF” in professional activities. 
• An official certificate and pin denoting your status. 
• International acknowledgment at Digestive Disease Week® (DDW).
• A listing on the AGA website alongside esteemed peers.  
• A pre-written, fill-in press release and a digital badge to inform others of your accomplishment.

Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24.

Applications are now open for the 2022 AGA Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education or research (basic or clinical) are encouraged to apply today.

Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:

• The privilege of using the designation “AGAF” in professional activities. 
• An official certificate and pin denoting your status. 
• International acknowledgment at Digestive Disease Week® (DDW).
• A listing on the AGA website alongside esteemed peers.  
• A pre-written, fill-in press release and a digital badge to inform others of your accomplishment.

Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24.

Applications are now open for the 2022 AGA Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education or research (basic or clinical) are encouraged to apply today.

Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:

• The privilege of using the designation “AGAF” in professional activities. 
• An official certificate and pin denoting your status. 
• International acknowledgment at Digestive Disease Week® (DDW).
• A listing on the AGA website alongside esteemed peers.  
• A pre-written, fill-in press release and a digital badge to inform others of your accomplishment.

Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. Here’s a preview of a recent popular clinical discussion:

From Jennifer Weiss, MD, MS, AGAF: Implementing CRC screening at 45:

The ACS recommended lowering the CRC screening age to 45, ACG has recently followed suit, and the USPSTF draft revisions also support a lower CRC screening age. In this month of colorectal cancer awareness, I was wondering how many people have started implementing this change in their practice and if they have received any pushback from insurance companies?

See how AGA members responded and join the discussion: https://community.gastro.org/posts/23923

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. Here’s a preview of a recent popular clinical discussion:

From Jennifer Weiss, MD, MS, AGAF: Implementing CRC screening at 45:

The ACS recommended lowering the CRC screening age to 45, ACG has recently followed suit, and the USPSTF draft revisions also support a lower CRC screening age. In this month of colorectal cancer awareness, I was wondering how many people have started implementing this change in their practice and if they have received any pushback from insurance companies?

See how AGA members responded and join the discussion: https://community.gastro.org/posts/23923

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community (https://community.gastro.org) to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. Here’s a preview of a recent popular clinical discussion:

From Jennifer Weiss, MD, MS, AGAF: Implementing CRC screening at 45:

The ACS recommended lowering the CRC screening age to 45, ACG has recently followed suit, and the USPSTF draft revisions also support a lower CRC screening age. In this month of colorectal cancer awareness, I was wondering how many people have started implementing this change in their practice and if they have received any pushback from insurance companies?

See how AGA members responded and join the discussion: https://community.gastro.org/posts/23923

This May, DDW will again be a virtual meeting. Not only does this pandemic continue, but it has re-emerged with a vengeance in several states. Michigan leads the nation in cases per 100,000, with the UK variant now predominant. Younger adults are being most impacted. There have been almost 250 confirmed COVID-19 cases in fully vaccinated people in Michigan. COVID-19 will be with us for a long time.

Despite the disruption caused by the coronavirus, scientific research and the need for up-to-date education continues. There are numerous educational sessions that will be available for us to view and opportunities for interacting with speakers in many. I hope you will take advantage of a virtual DDW to refresh knowledge and learn about new modalities to care for our patients.

Three cover stories this month should be of interest. A new AGA guideline has been published and it recognizes the advances made in construction and use of intragastric balloons. Current balloons positively add to weigh loss and, when used correctly, are safer and more effective than in the past. Gastroenterologists should enter the bariatric arena in multiple ways from lifestyle counseling to endoscopic therapies. We have much to add to this field. Another cover article concerns infliximab’s influence on development of COVID-19 antibodies. The last discusses how minority status influences liver transplant listing; we continue to uncover the impact of implicit bias in our medical decisions.

I hope you continue to take care of yourself, your families, and those in your communities. We are close to a return to normalcy but are not out of the woods yet. This is a time of reset in our nation, and we all should remember that we are a social network that works only when we look beyond ourselves. I have quoted Tom Friedman before: “Respect science, respect nature, respect each other.”

Have a happy and healthy spring.

John I. Allen, MD, MBA, AGAF
Editor in Chief

This May, DDW will again be a virtual meeting. Not only does this pandemic continue, but it has re-emerged with a vengeance in several states. Michigan leads the nation in cases per 100,000, with the UK variant now predominant. Younger adults are being most impacted. There have been almost 250 confirmed COVID-19 cases in fully vaccinated people in Michigan. COVID-19 will be with us for a long time.

Despite the disruption caused by the coronavirus, scientific research and the need for up-to-date education continues. There are numerous educational sessions that will be available for us to view and opportunities for interacting with speakers in many. I hope you will take advantage of a virtual DDW to refresh knowledge and learn about new modalities to care for our patients.

Three cover stories this month should be of interest. A new AGA guideline has been published and it recognizes the advances made in construction and use of intragastric balloons. Current balloons positively add to weigh loss and, when used correctly, are safer and more effective than in the past. Gastroenterologists should enter the bariatric arena in multiple ways from lifestyle counseling to endoscopic therapies. We have much to add to this field. Another cover article concerns infliximab’s influence on development of COVID-19 antibodies. The last discusses how minority status influences liver transplant listing; we continue to uncover the impact of implicit bias in our medical decisions.

I hope you continue to take care of yourself, your families, and those in your communities. We are close to a return to normalcy but are not out of the woods yet. This is a time of reset in our nation, and we all should remember that we are a social network that works only when we look beyond ourselves. I have quoted Tom Friedman before: “Respect science, respect nature, respect each other.”

Have a happy and healthy spring.

John I. Allen, MD, MBA, AGAF
Editor in Chief

This May, DDW will again be a virtual meeting. Not only does this pandemic continue, but it has re-emerged with a vengeance in several states. Michigan leads the nation in cases per 100,000, with the UK variant now predominant. Younger adults are being most impacted. There have been almost 250 confirmed COVID-19 cases in fully vaccinated people in Michigan. COVID-19 will be with us for a long time.

Despite the disruption caused by the coronavirus, scientific research and the need for up-to-date education continues. There are numerous educational sessions that will be available for us to view and opportunities for interacting with speakers in many. I hope you will take advantage of a virtual DDW to refresh knowledge and learn about new modalities to care for our patients.

Three cover stories this month should be of interest. A new AGA guideline has been published and it recognizes the advances made in construction and use of intragastric balloons. Current balloons positively add to weigh loss and, when used correctly, are safer and more effective than in the past. Gastroenterologists should enter the bariatric arena in multiple ways from lifestyle counseling to endoscopic therapies. We have much to add to this field. Another cover article concerns infliximab’s influence on development of COVID-19 antibodies. The last discusses how minority status influences liver transplant listing; we continue to uncover the impact of implicit bias in our medical decisions.

I hope you continue to take care of yourself, your families, and those in your communities. We are close to a return to normalcy but are not out of the woods yet. This is a time of reset in our nation, and we all should remember that we are a social network that works only when we look beyond ourselves. I have quoted Tom Friedman before: “Respect science, respect nature, respect each other.”

Have a happy and healthy spring.

John I. Allen, MD, MBA, AGAF
Editor in Chief

Moral distress can result when health professionals like doctors and nurses feel prevented from doing what they know is right and ethically correct – reflecting the values of their profession and their own sense of professional integrity – because of unmanageable caseload demands, lack of resources, coverage limitations, or institutional policies.

Hospitalists are not exempt from moral distress, which is associated with soul-searching, burnout, and even PTSD. It is also associated with a higher likelihood for professionals to report an intention to leave their jobs. But the COVID-19 pandemic has superimposed a whole new layer of challenges, constraints, and frustrations, creating a potent mix of trauma and exhaustion, cumulative unease, depleted job satisfaction, and difficult ethical choices.

These challenges include seeing so many patients die and working with short supplies of personal protective equipment (PPE) – with resulting fears that they could catch the virus or pass it on to others, including loved ones. Also, not having enough ventilators or even beds for patients in hospitals hit hard by COVID surges raises fears that decisions for rationing medical care might become necessary.

In a commentary published in the Journal of General Internal Medicine in October 2019 – shortly before the COVID pandemic burst onto the scene – hospitalist and medical sociologist Elizabeth Dzeng, MD, PhD, MPH, and hospital medicine pioneer Robert Wachter, MD, MHM, both from the University of California, San Francisco, described “moral distress and professional ethical dissonance as root causes of burnout.”¹ They characterized moral distress by its emotional exhaustion, depersonalization, reduced sense of accomplishment, and moral apathy, and they called for renewed attention to social and ethical dimensions of practice and threats to physician professionalism.

Prevailing explanations for documented high rates of burnout in doctors have tended to focus on work hours and struggles with electronic medical records and the like, Dr. Dzeng and Dr. Wachter wrote. “We see evidence of an insidious moral distress resulting from physicians’ inability to act in accord with their individual and professional ethical values due to institutional and social constraints.”

COVID has intensified these issues surrounding moral distress. “In a short period of time it created more situations that raise issues of moral distress than I have seen since the early days of HIV,” Dr. Wachter said. “Those of us who work in hospitals often find ourselves in complex circumstances with limited resources. What was so striking about COVID was finding ourselves caring for large volumes of patients who had a condition that was new to us.”

And the fact that constraints imposed by COVID, such as having to don unwieldy PPE and not allowing families to be present with hospitalized loved ones, are explainable and rational only helps a little with the clinician’s distress.

People talk about the need for doctors to be more resilient, Dr. Dzeng added, but that’s too narrow of an approach to these very real challenges. There are huge issues of workforce retention and costs, major mental health issues, suicide – and implications for patient care, because burned-out doctors can be bad doctors.
 

What is moral distress?

Moral distress is a term from the nursing ethics literature, attributed to philosopher Andrew Jameton in 1984.² Contributors to moral distress imposed by COVID include having to make difficult medical decisions under stressful circumstances – especially early on, when effective treatment options were few. Doctors felt the demands of the pandemic were putting care quality and patient safety at risk. Poor working conditions overall, being pushed to work beyond their normal physical limits for days at a time, and feelings of not being valued added to this stress. But some say the pandemic has only highlighted and amplified existing inequities and disparities in the health care system.

Experts say moral distress is about feeling powerless, especially in a system driven by market values, and feeling let down by a society that has put them in harm’s way. They work all day under physically and emotionally exhausting conditions and then go home to hear specious conspiracy theories about the pandemic and see other people unwilling to wear masks.

Moral distress is complicated, said Lucia Wocial, PhD, RN, a nurse ethicist and cochair of the ethics consultation subcommittee at Indiana University Health in Indianapolis. “If you say you have moral distress, my first response is: tell me more. It helps to peel back the layers of this complexity. Emotion is only part of moral distress. It’s about the professional’s sense of responsibility and obligation – and the inability to honor that.”

Dr. Wocial, whose research specialty is moral distress, is corresponding author of a study published in the Journal of General Internal Medicine in February 2020, which identified moral distress in 4 out of 10 surveyed physicians who cared for older hospitalized adults and found themselves needing to work with their surrogate decision-makers.³ “We know physician moral distress is higher when people haven’t had the chance to hold conversations about their end-of-life care preferences,” she said, such as whether to continue life support.

“We have also learned that communication is key to diminishing physician moral distress. Our responsibility as clinicians is to guide patients and families through these decisions. If the family feels a high level of support from me, then my moral distress is lower,” she added. “If you think about how COVID has evolved, at first people were dying so quickly. Some patients were going to the ICU on ventilators without ever having a goals-of-care conversation.”

COVID has shifted the usual standard of care in U.S. hospitals in the face of patient surges. “How can you feel okay in accepting a level of care that in the prepandemic world would not have been acceptable?” Dr. Wocial posed. “What if you know the standard of care has shifted, of necessity, but you haven’t had time to prepare for it and nobody’s talking about what that means? Who is going to help you accept that good enough under these circumstances is enough – at least for today?”
 

What to call it

Michael J. Asken, PhD, director of provider well-being at UPMC Pinnacle Harrisburg (Pa.), has questioned in print the use of the military and wartime term “moral injury” when applied to a variety of less serious physician stressors.⁴ More recently, however, he observed, “The pandemic has muted or erased many of the distinctions between medical care and military conflict. ... The onslaught and volume of critical patients and resulting deaths is beyond what most providers have ever contemplated as part of care.”⁵

In a recent interview with the Hospitalist, he said: “While I initially resisted using the term moral injury, especially pre-COVID, because it was not equivalent to the moral injury created by war, I have relented a bit.” The volume of deaths and the apparent dangers to providers themselves reflect some of the critical aspects of war, and repetitive, intense, and/or incessant ethical challenges may have longer term negative psychological or emotional effects.

“Feeling emotional pain in situations of multiple deaths is to be expected and, perhaps, should even be welcomed as a sign of retained humanity and a buffer against burnout and cynicism in these times of unabating stress,” Dr. Asken said. “This is only true, however, if the emotional impact is tolerable and not experienced in repetitive extremes.”

Courtesy Avera Health

“These things are real,” said Clarissa Barnes, MD, a physician adviser, hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and former medical director of Avera’s LIGHT Program, a wellness-oriented service for clinicians. Dr. Barnes herself caught the virus on the job but has since recovered.

“Physicians don’t see their work as an occupation. It’s their core identity: I am a doctor; I practice medicine. If things are being done in ways I don’t think are right, that’s fundamentally a breach,” she said. “As internists, we have an opportunity to forestall death whenever we can and, if not, promote a peaceful death. That’s what made me choose this specialty. I think there’s value in allowing a person to end well. But when that doesn’t happen because of social or administrative reasons, that’s hard.”
 

Where is the leadership?

“A lot of moral injury comes down to the individual health system and its leaders. Some have done well; others you hear saying things that make you question whether these are the people you want leading the organization. Hospitalists need to have a clear value framework and an idea of how to negotiate things when decisions don’t match that framework,” Dr. Barnes said.

“Sometimes administrators have additional information that they’re not sharing,” she added. “They’re caught between a rock and a hard place regarding the decisions they have to make, but they need to be more transparent and not hold things so close to their vest while thinking they are helping clinicians [by doing so]. Physicians need to understand why they are being asked to do things counter to what they believe is appropriate.”

David Oliver, MD, a geriatrics and internal medicine consultant at Royal Berkshire Hospital in Reading, England, also practices as a hospital physician, a role similar to the hospitalist in the United States. “In any system, in any environment, the job of being a doctor, nurse, or other health professional carries a lot of responsibility. That is a timeless, inherent stress of medical practice. With COVID, we’ve seen a lot of emotional burdens – a whole separate set of problems outside of your control, where you are responsible for care but don’t have accountability,” he said.

“People like me, hospital doctors, are used to chronic workforce issues in the National Health Service. But we didn’t sign up to come and get COVID and be hospitalized ourselves.” More than 850 frontline health care providers in the U.K. have so far died from the virus, Dr. Oliver said. “I saw five patients die in 90 minutes one day in April. That’s above and beyond normal human capacity.”

In England specifically, he said, it has exposed underlying structural issues and serious workforce gaps, unfilled vacancies, and a much lower number of ICU beds per 100,000 population than the United States or Europe. And there is consistent pressure to send patients home in order to empty beds for new patients.

But a range of supportive services is offered in U.K. hospitals, such as making senior clinicians available to speak to frontline clinicians, providing mentorship and a sounding board. The Point of Care Foundation has helped to disseminate the practice of Schwartz Rounds, a group reflective practice forum for health care teams developed by the Schwartz Center for Compassionate Healthcare in Boston.

“We don’t need this clap-for-the-NHS heroes stuff,” Dr. Oliver said. “We need an adequate workforce and [better] working conditions. What happened on the front lines of the pandemic was heroic – all done by local clinical teams. But where was the government – the centralized NHS? A lot of frontline clinicians aren’t feeling valued, supported, or listened to.”
 

What can be done?

What are some things that hospitalists can do, individually and collectively, to try to prevent moral distress from turning into full-scale burnout? Dr. Wocial emphasized the importance of unit-based ethics conversations. “At IU Health we have someone who is available to sit down with frontline clinicians and help unpack what they are experiencing,” she said. Clinicians need to be able to process this terrible experience in order to sort out the feelings of sadness from questions of whether they are doing something wrong.

Hospital chaplains are exquisitely skilled at supporting people and debriefing hospital teams, Dr. Wocial added. Palliative care professionals are also skilled at facilitating goals of care conversations with patients and families and can support hospitalists through coaching and joint family meetings.

“It’s about raising your sense of agency in your job – what in your practice you can control. People need to be able to talk frankly about it. Some managers say to clinicians: ‘Just buck up,’ while others are doing a fabulous job of offering support to their staff,” Dr. Wocial said. Hospitalists have to be willing to say when they’ve had too much. “You may not get help when you first ask for it. Be persistent. Asking for help doesn’t make you weak.”

Most doctors have their own strategies for managing stress on the job, Dr. Wachter noted. “What makes it a little easier is not having to do it alone. Many find solace in community, but community has been constrained by this pandemic. You can’t just go out for a beer after work anymore. So what are other ways to let off steam?”

The people leading hospitalist programs need to work harder at creating community and empathy when the tools allowing people to get together are somewhat limited. “Everybody is tired of Zoom,” he said. “One thing I learned as a manager was to just send messages to people acknowledging that I know this is hard. Try to think from the lens of other people and what they would find useful.”

The pandemic has been terribly unpredictable, Dr. Wachter added, but it won’t go on forever. For some doctors, yoga or mindfulness meditation may be very comforting. “For me, that’s not what I do. Golf or a good Seinfeld episode works for me.”

SHM’s Wellbeing Taskforce has created a “Hospital Medicine COVID Check-in Guide for Self & Peers” to promote both sharing and support for one another. It can be found at SHM’s Wellbeing webpage [www.hospitalmedicine.org/practice-management/wellbeing/]. The Taskforce believes that sharing common stressors as hospitalists can be healing, said its chair, Sarah Richards, MD, assistant professor of medicine at the University of Nebraska, Omaha. “This is especially true in situations where we feel we can’t provide the type of care we know our patients deserve.”
 

Respect, advocacy, self-care

Dr. Asken encouraged clinicians to focus on the efforts they are making on the job, not just the outcomes. “If someone has done their absolute best in a given circumstance, satisfaction and solace needs to be taken from that,” he said.

“Ongoing support group meetings, which we have called frontline support groups, should occur on a regular basis. Designated for physicians on the medical floors and in critical care units who are directly involved with COVID patients, these provide a brief respite but also engagement, sharing, and strengthening of mutual support.”

A lot of these issues have a fundamental thread, which comes down to respect, Dr. Barnes said. “Hospitalists need to hear their hospital administrators say: ‘I hear what you’re saying [about a problem]. Let’s think together about how to solve it.’ We need to work on being clear, and we need to speak up for what’s right. If you aren’t comfortable doing things you are being asked to do in the hospital, maybe you’re not working in the right place.”

Some efforts in the area of wellness and self-care really are helpful, Dr. Barnes said. “But you can’t exercise you way through a health system that doesn’t respect you. You need to get out of the mindset that you have no ability to make things different. We are not powerless as doctors. We can do a lot, actually. Physicians need to take ownership. If you are a hospitalist and you’re not part of any local or state or national organization that advocates for physicians, you should be.”
 

References

1. Dzeng L and Wachter RM. Ethics in conflict: Moral distress as a root cause of burnout. J Gen Intern Med. 2020 Feb;35(2):409-11. doi: 10.1007/s11606-019-05505-6.

2. Jameton A, Nursing Practice: The ethical issues. Prentice Hall Series in the Philosophy of Medicine. 1984, Englewood Cliffs, N.J.: Prentice Hall.

3. Wocial LD et al. Factors associated with physician moral distress caring for hospitalized elderly patients needing a surrogate decision-maker: A prospective study. J Gen Intern Med. 2020 May;35(5):1405-12. doi: 10.1007/s11606-020-05652-1.

4. Asken MJ. It’s not moral injury: It’s burnout (or something else). Medical Economics; June 7, 2019.

5. Asken MJ. Now it is moral injury: The COVID-19 pandemic and moral distress. Medical Economics; April 29, 2020.

Moral distress can result when health professionals like doctors and nurses feel prevented from doing what they know is right and ethically correct – reflecting the values of their profession and their own sense of professional integrity – because of unmanageable caseload demands, lack of resources, coverage limitations, or institutional policies.

Hospitalists are not exempt from moral distress, which is associated with soul-searching, burnout, and even PTSD. It is also associated with a higher likelihood for professionals to report an intention to leave their jobs. But the COVID-19 pandemic has superimposed a whole new layer of challenges, constraints, and frustrations, creating a potent mix of trauma and exhaustion, cumulative unease, depleted job satisfaction, and difficult ethical choices.

These challenges include seeing so many patients die and working with short supplies of personal protective equipment (PPE) – with resulting fears that they could catch the virus or pass it on to others, including loved ones. Also, not having enough ventilators or even beds for patients in hospitals hit hard by COVID surges raises fears that decisions for rationing medical care might become necessary.

In a commentary published in the Journal of General Internal Medicine in October 2019 – shortly before the COVID pandemic burst onto the scene – hospitalist and medical sociologist Elizabeth Dzeng, MD, PhD, MPH, and hospital medicine pioneer Robert Wachter, MD, MHM, both from the University of California, San Francisco, described “moral distress and professional ethical dissonance as root causes of burnout.”¹ They characterized moral distress by its emotional exhaustion, depersonalization, reduced sense of accomplishment, and moral apathy, and they called for renewed attention to social and ethical dimensions of practice and threats to physician professionalism.

Prevailing explanations for documented high rates of burnout in doctors have tended to focus on work hours and struggles with electronic medical records and the like, Dr. Dzeng and Dr. Wachter wrote. “We see evidence of an insidious moral distress resulting from physicians’ inability to act in accord with their individual and professional ethical values due to institutional and social constraints.”

COVID has intensified these issues surrounding moral distress. “In a short period of time it created more situations that raise issues of moral distress than I have seen since the early days of HIV,” Dr. Wachter said. “Those of us who work in hospitals often find ourselves in complex circumstances with limited resources. What was so striking about COVID was finding ourselves caring for large volumes of patients who had a condition that was new to us.”

And the fact that constraints imposed by COVID, such as having to don unwieldy PPE and not allowing families to be present with hospitalized loved ones, are explainable and rational only helps a little with the clinician’s distress.

People talk about the need for doctors to be more resilient, Dr. Dzeng added, but that’s too narrow of an approach to these very real challenges. There are huge issues of workforce retention and costs, major mental health issues, suicide – and implications for patient care, because burned-out doctors can be bad doctors.
 

What is moral distress?

Moral distress is a term from the nursing ethics literature, attributed to philosopher Andrew Jameton in 1984.² Contributors to moral distress imposed by COVID include having to make difficult medical decisions under stressful circumstances – especially early on, when effective treatment options were few. Doctors felt the demands of the pandemic were putting care quality and patient safety at risk. Poor working conditions overall, being pushed to work beyond their normal physical limits for days at a time, and feelings of not being valued added to this stress. But some say the pandemic has only highlighted and amplified existing inequities and disparities in the health care system.

Experts say moral distress is about feeling powerless, especially in a system driven by market values, and feeling let down by a society that has put them in harm’s way. They work all day under physically and emotionally exhausting conditions and then go home to hear specious conspiracy theories about the pandemic and see other people unwilling to wear masks.

Moral distress is complicated, said Lucia Wocial, PhD, RN, a nurse ethicist and cochair of the ethics consultation subcommittee at Indiana University Health in Indianapolis. “If you say you have moral distress, my first response is: tell me more. It helps to peel back the layers of this complexity. Emotion is only part of moral distress. It’s about the professional’s sense of responsibility and obligation – and the inability to honor that.”

Dr. Wocial, whose research specialty is moral distress, is corresponding author of a study published in the Journal of General Internal Medicine in February 2020, which identified moral distress in 4 out of 10 surveyed physicians who cared for older hospitalized adults and found themselves needing to work with their surrogate decision-makers.³ “We know physician moral distress is higher when people haven’t had the chance to hold conversations about their end-of-life care preferences,” she said, such as whether to continue life support.

“We have also learned that communication is key to diminishing physician moral distress. Our responsibility as clinicians is to guide patients and families through these decisions. If the family feels a high level of support from me, then my moral distress is lower,” she added. “If you think about how COVID has evolved, at first people were dying so quickly. Some patients were going to the ICU on ventilators without ever having a goals-of-care conversation.”

COVID has shifted the usual standard of care in U.S. hospitals in the face of patient surges. “How can you feel okay in accepting a level of care that in the prepandemic world would not have been acceptable?” Dr. Wocial posed. “What if you know the standard of care has shifted, of necessity, but you haven’t had time to prepare for it and nobody’s talking about what that means? Who is going to help you accept that good enough under these circumstances is enough – at least for today?”
 

What to call it

Michael J. Asken, PhD, director of provider well-being at UPMC Pinnacle Harrisburg (Pa.), has questioned in print the use of the military and wartime term “moral injury” when applied to a variety of less serious physician stressors.⁴ More recently, however, he observed, “The pandemic has muted or erased many of the distinctions between medical care and military conflict. ... The onslaught and volume of critical patients and resulting deaths is beyond what most providers have ever contemplated as part of care.”⁵

In a recent interview with the Hospitalist, he said: “While I initially resisted using the term moral injury, especially pre-COVID, because it was not equivalent to the moral injury created by war, I have relented a bit.” The volume of deaths and the apparent dangers to providers themselves reflect some of the critical aspects of war, and repetitive, intense, and/or incessant ethical challenges may have longer term negative psychological or emotional effects.

“Feeling emotional pain in situations of multiple deaths is to be expected and, perhaps, should even be welcomed as a sign of retained humanity and a buffer against burnout and cynicism in these times of unabating stress,” Dr. Asken said. “This is only true, however, if the emotional impact is tolerable and not experienced in repetitive extremes.”

Courtesy Avera Health

“These things are real,” said Clarissa Barnes, MD, a physician adviser, hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and former medical director of Avera’s LIGHT Program, a wellness-oriented service for clinicians. Dr. Barnes herself caught the virus on the job but has since recovered.

“Physicians don’t see their work as an occupation. It’s their core identity: I am a doctor; I practice medicine. If things are being done in ways I don’t think are right, that’s fundamentally a breach,” she said. “As internists, we have an opportunity to forestall death whenever we can and, if not, promote a peaceful death. That’s what made me choose this specialty. I think there’s value in allowing a person to end well. But when that doesn’t happen because of social or administrative reasons, that’s hard.”
 

Where is the leadership?

“A lot of moral injury comes down to the individual health system and its leaders. Some have done well; others you hear saying things that make you question whether these are the people you want leading the organization. Hospitalists need to have a clear value framework and an idea of how to negotiate things when decisions don’t match that framework,” Dr. Barnes said.

“Sometimes administrators have additional information that they’re not sharing,” she added. “They’re caught between a rock and a hard place regarding the decisions they have to make, but they need to be more transparent and not hold things so close to their vest while thinking they are helping clinicians [by doing so]. Physicians need to understand why they are being asked to do things counter to what they believe is appropriate.”

David Oliver, MD, a geriatrics and internal medicine consultant at Royal Berkshire Hospital in Reading, England, also practices as a hospital physician, a role similar to the hospitalist in the United States. “In any system, in any environment, the job of being a doctor, nurse, or other health professional carries a lot of responsibility. That is a timeless, inherent stress of medical practice. With COVID, we’ve seen a lot of emotional burdens – a whole separate set of problems outside of your control, where you are responsible for care but don’t have accountability,” he said.

“People like me, hospital doctors, are used to chronic workforce issues in the National Health Service. But we didn’t sign up to come and get COVID and be hospitalized ourselves.” More than 850 frontline health care providers in the U.K. have so far died from the virus, Dr. Oliver said. “I saw five patients die in 90 minutes one day in April. That’s above and beyond normal human capacity.”

In England specifically, he said, it has exposed underlying structural issues and serious workforce gaps, unfilled vacancies, and a much lower number of ICU beds per 100,000 population than the United States or Europe. And there is consistent pressure to send patients home in order to empty beds for new patients.

But a range of supportive services is offered in U.K. hospitals, such as making senior clinicians available to speak to frontline clinicians, providing mentorship and a sounding board. The Point of Care Foundation has helped to disseminate the practice of Schwartz Rounds, a group reflective practice forum for health care teams developed by the Schwartz Center for Compassionate Healthcare in Boston.

“We don’t need this clap-for-the-NHS heroes stuff,” Dr. Oliver said. “We need an adequate workforce and [better] working conditions. What happened on the front lines of the pandemic was heroic – all done by local clinical teams. But where was the government – the centralized NHS? A lot of frontline clinicians aren’t feeling valued, supported, or listened to.”
 

What can be done?

What are some things that hospitalists can do, individually and collectively, to try to prevent moral distress from turning into full-scale burnout? Dr. Wocial emphasized the importance of unit-based ethics conversations. “At IU Health we have someone who is available to sit down with frontline clinicians and help unpack what they are experiencing,” she said. Clinicians need to be able to process this terrible experience in order to sort out the feelings of sadness from questions of whether they are doing something wrong.

Hospital chaplains are exquisitely skilled at supporting people and debriefing hospital teams, Dr. Wocial added. Palliative care professionals are also skilled at facilitating goals of care conversations with patients and families and can support hospitalists through coaching and joint family meetings.

“It’s about raising your sense of agency in your job – what in your practice you can control. People need to be able to talk frankly about it. Some managers say to clinicians: ‘Just buck up,’ while others are doing a fabulous job of offering support to their staff,” Dr. Wocial said. Hospitalists have to be willing to say when they’ve had too much. “You may not get help when you first ask for it. Be persistent. Asking for help doesn’t make you weak.”

Most doctors have their own strategies for managing stress on the job, Dr. Wachter noted. “What makes it a little easier is not having to do it alone. Many find solace in community, but community has been constrained by this pandemic. You can’t just go out for a beer after work anymore. So what are other ways to let off steam?”

The people leading hospitalist programs need to work harder at creating community and empathy when the tools allowing people to get together are somewhat limited. “Everybody is tired of Zoom,” he said. “One thing I learned as a manager was to just send messages to people acknowledging that I know this is hard. Try to think from the lens of other people and what they would find useful.”

The pandemic has been terribly unpredictable, Dr. Wachter added, but it won’t go on forever. For some doctors, yoga or mindfulness meditation may be very comforting. “For me, that’s not what I do. Golf or a good Seinfeld episode works for me.”

SHM’s Wellbeing Taskforce has created a “Hospital Medicine COVID Check-in Guide for Self & Peers” to promote both sharing and support for one another. It can be found at SHM’s Wellbeing webpage [www.hospitalmedicine.org/practice-management/wellbeing/]. The Taskforce believes that sharing common stressors as hospitalists can be healing, said its chair, Sarah Richards, MD, assistant professor of medicine at the University of Nebraska, Omaha. “This is especially true in situations where we feel we can’t provide the type of care we know our patients deserve.”
 

Respect, advocacy, self-care

Dr. Asken encouraged clinicians to focus on the efforts they are making on the job, not just the outcomes. “If someone has done their absolute best in a given circumstance, satisfaction and solace needs to be taken from that,” he said.

“Ongoing support group meetings, which we have called frontline support groups, should occur on a regular basis. Designated for physicians on the medical floors and in critical care units who are directly involved with COVID patients, these provide a brief respite but also engagement, sharing, and strengthening of mutual support.”

A lot of these issues have a fundamental thread, which comes down to respect, Dr. Barnes said. “Hospitalists need to hear their hospital administrators say: ‘I hear what you’re saying [about a problem]. Let’s think together about how to solve it.’ We need to work on being clear, and we need to speak up for what’s right. If you aren’t comfortable doing things you are being asked to do in the hospital, maybe you’re not working in the right place.”

Some efforts in the area of wellness and self-care really are helpful, Dr. Barnes said. “But you can’t exercise you way through a health system that doesn’t respect you. You need to get out of the mindset that you have no ability to make things different. We are not powerless as doctors. We can do a lot, actually. Physicians need to take ownership. If you are a hospitalist and you’re not part of any local or state or national organization that advocates for physicians, you should be.”
 

References

1. Dzeng L and Wachter RM. Ethics in conflict: Moral distress as a root cause of burnout. J Gen Intern Med. 2020 Feb;35(2):409-11. doi: 10.1007/s11606-019-05505-6.

2. Jameton A, Nursing Practice: The ethical issues. Prentice Hall Series in the Philosophy of Medicine. 1984, Englewood Cliffs, N.J.: Prentice Hall.

3. Wocial LD et al. Factors associated with physician moral distress caring for hospitalized elderly patients needing a surrogate decision-maker: A prospective study. J Gen Intern Med. 2020 May;35(5):1405-12. doi: 10.1007/s11606-020-05652-1.

4. Asken MJ. It’s not moral injury: It’s burnout (or something else). Medical Economics; June 7, 2019.

5. Asken MJ. Now it is moral injury: The COVID-19 pandemic and moral distress. Medical Economics; April 29, 2020.

Moral distress can result when health professionals like doctors and nurses feel prevented from doing what they know is right and ethically correct – reflecting the values of their profession and their own sense of professional integrity – because of unmanageable caseload demands, lack of resources, coverage limitations, or institutional policies.

Hospitalists are not exempt from moral distress, which is associated with soul-searching, burnout, and even PTSD. It is also associated with a higher likelihood for professionals to report an intention to leave their jobs. But the COVID-19 pandemic has superimposed a whole new layer of challenges, constraints, and frustrations, creating a potent mix of trauma and exhaustion, cumulative unease, depleted job satisfaction, and difficult ethical choices.

These challenges include seeing so many patients die and working with short supplies of personal protective equipment (PPE) – with resulting fears that they could catch the virus or pass it on to others, including loved ones. Also, not having enough ventilators or even beds for patients in hospitals hit hard by COVID surges raises fears that decisions for rationing medical care might become necessary.

In a commentary published in the Journal of General Internal Medicine in October 2019 – shortly before the COVID pandemic burst onto the scene – hospitalist and medical sociologist Elizabeth Dzeng, MD, PhD, MPH, and hospital medicine pioneer Robert Wachter, MD, MHM, both from the University of California, San Francisco, described “moral distress and professional ethical dissonance as root causes of burnout.”¹ They characterized moral distress by its emotional exhaustion, depersonalization, reduced sense of accomplishment, and moral apathy, and they called for renewed attention to social and ethical dimensions of practice and threats to physician professionalism.

Prevailing explanations for documented high rates of burnout in doctors have tended to focus on work hours and struggles with electronic medical records and the like, Dr. Dzeng and Dr. Wachter wrote. “We see evidence of an insidious moral distress resulting from physicians’ inability to act in accord with their individual and professional ethical values due to institutional and social constraints.”

COVID has intensified these issues surrounding moral distress. “In a short period of time it created more situations that raise issues of moral distress than I have seen since the early days of HIV,” Dr. Wachter said. “Those of us who work in hospitals often find ourselves in complex circumstances with limited resources. What was so striking about COVID was finding ourselves caring for large volumes of patients who had a condition that was new to us.”

And the fact that constraints imposed by COVID, such as having to don unwieldy PPE and not allowing families to be present with hospitalized loved ones, are explainable and rational only helps a little with the clinician’s distress.

People talk about the need for doctors to be more resilient, Dr. Dzeng added, but that’s too narrow of an approach to these very real challenges. There are huge issues of workforce retention and costs, major mental health issues, suicide – and implications for patient care, because burned-out doctors can be bad doctors.
 

What is moral distress?

Moral distress is a term from the nursing ethics literature, attributed to philosopher Andrew Jameton in 1984.² Contributors to moral distress imposed by COVID include having to make difficult medical decisions under stressful circumstances – especially early on, when effective treatment options were few. Doctors felt the demands of the pandemic were putting care quality and patient safety at risk. Poor working conditions overall, being pushed to work beyond their normal physical limits for days at a time, and feelings of not being valued added to this stress. But some say the pandemic has only highlighted and amplified existing inequities and disparities in the health care system.

Experts say moral distress is about feeling powerless, especially in a system driven by market values, and feeling let down by a society that has put them in harm’s way. They work all day under physically and emotionally exhausting conditions and then go home to hear specious conspiracy theories about the pandemic and see other people unwilling to wear masks.

Moral distress is complicated, said Lucia Wocial, PhD, RN, a nurse ethicist and cochair of the ethics consultation subcommittee at Indiana University Health in Indianapolis. “If you say you have moral distress, my first response is: tell me more. It helps to peel back the layers of this complexity. Emotion is only part of moral distress. It’s about the professional’s sense of responsibility and obligation – and the inability to honor that.”

Dr. Wocial, whose research specialty is moral distress, is corresponding author of a study published in the Journal of General Internal Medicine in February 2020, which identified moral distress in 4 out of 10 surveyed physicians who cared for older hospitalized adults and found themselves needing to work with their surrogate decision-makers.³ “We know physician moral distress is higher when people haven’t had the chance to hold conversations about their end-of-life care preferences,” she said, such as whether to continue life support.

“We have also learned that communication is key to diminishing physician moral distress. Our responsibility as clinicians is to guide patients and families through these decisions. If the family feels a high level of support from me, then my moral distress is lower,” she added. “If you think about how COVID has evolved, at first people were dying so quickly. Some patients were going to the ICU on ventilators without ever having a goals-of-care conversation.”

COVID has shifted the usual standard of care in U.S. hospitals in the face of patient surges. “How can you feel okay in accepting a level of care that in the prepandemic world would not have been acceptable?” Dr. Wocial posed. “What if you know the standard of care has shifted, of necessity, but you haven’t had time to prepare for it and nobody’s talking about what that means? Who is going to help you accept that good enough under these circumstances is enough – at least for today?”
 

What to call it

Michael J. Asken, PhD, director of provider well-being at UPMC Pinnacle Harrisburg (Pa.), has questioned in print the use of the military and wartime term “moral injury” when applied to a variety of less serious physician stressors.⁴ More recently, however, he observed, “The pandemic has muted or erased many of the distinctions between medical care and military conflict. ... The onslaught and volume of critical patients and resulting deaths is beyond what most providers have ever contemplated as part of care.”⁵

In a recent interview with the Hospitalist, he said: “While I initially resisted using the term moral injury, especially pre-COVID, because it was not equivalent to the moral injury created by war, I have relented a bit.” The volume of deaths and the apparent dangers to providers themselves reflect some of the critical aspects of war, and repetitive, intense, and/or incessant ethical challenges may have longer term negative psychological or emotional effects.

“Feeling emotional pain in situations of multiple deaths is to be expected and, perhaps, should even be welcomed as a sign of retained humanity and a buffer against burnout and cynicism in these times of unabating stress,” Dr. Asken said. “This is only true, however, if the emotional impact is tolerable and not experienced in repetitive extremes.”

Courtesy Avera Health

“These things are real,” said Clarissa Barnes, MD, a physician adviser, hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and former medical director of Avera’s LIGHT Program, a wellness-oriented service for clinicians. Dr. Barnes herself caught the virus on the job but has since recovered.

“Physicians don’t see their work as an occupation. It’s their core identity: I am a doctor; I practice medicine. If things are being done in ways I don’t think are right, that’s fundamentally a breach,” she said. “As internists, we have an opportunity to forestall death whenever we can and, if not, promote a peaceful death. That’s what made me choose this specialty. I think there’s value in allowing a person to end well. But when that doesn’t happen because of social or administrative reasons, that’s hard.”
 

Where is the leadership?

“A lot of moral injury comes down to the individual health system and its leaders. Some have done well; others you hear saying things that make you question whether these are the people you want leading the organization. Hospitalists need to have a clear value framework and an idea of how to negotiate things when decisions don’t match that framework,” Dr. Barnes said.

“Sometimes administrators have additional information that they’re not sharing,” she added. “They’re caught between a rock and a hard place regarding the decisions they have to make, but they need to be more transparent and not hold things so close to their vest while thinking they are helping clinicians [by doing so]. Physicians need to understand why they are being asked to do things counter to what they believe is appropriate.”

David Oliver, MD, a geriatrics and internal medicine consultant at Royal Berkshire Hospital in Reading, England, also practices as a hospital physician, a role similar to the hospitalist in the United States. “In any system, in any environment, the job of being a doctor, nurse, or other health professional carries a lot of responsibility. That is a timeless, inherent stress of medical practice. With COVID, we’ve seen a lot of emotional burdens – a whole separate set of problems outside of your control, where you are responsible for care but don’t have accountability,” he said.

“People like me, hospital doctors, are used to chronic workforce issues in the National Health Service. But we didn’t sign up to come and get COVID and be hospitalized ourselves.” More than 850 frontline health care providers in the U.K. have so far died from the virus, Dr. Oliver said. “I saw five patients die in 90 minutes one day in April. That’s above and beyond normal human capacity.”

In England specifically, he said, it has exposed underlying structural issues and serious workforce gaps, unfilled vacancies, and a much lower number of ICU beds per 100,000 population than the United States or Europe. And there is consistent pressure to send patients home in order to empty beds for new patients.

But a range of supportive services is offered in U.K. hospitals, such as making senior clinicians available to speak to frontline clinicians, providing mentorship and a sounding board. The Point of Care Foundation has helped to disseminate the practice of Schwartz Rounds, a group reflective practice forum for health care teams developed by the Schwartz Center for Compassionate Healthcare in Boston.

“We don’t need this clap-for-the-NHS heroes stuff,” Dr. Oliver said. “We need an adequate workforce and [better] working conditions. What happened on the front lines of the pandemic was heroic – all done by local clinical teams. But where was the government – the centralized NHS? A lot of frontline clinicians aren’t feeling valued, supported, or listened to.”
 

What can be done?

What are some things that hospitalists can do, individually and collectively, to try to prevent moral distress from turning into full-scale burnout? Dr. Wocial emphasized the importance of unit-based ethics conversations. “At IU Health we have someone who is available to sit down with frontline clinicians and help unpack what they are experiencing,” she said. Clinicians need to be able to process this terrible experience in order to sort out the feelings of sadness from questions of whether they are doing something wrong.

Hospital chaplains are exquisitely skilled at supporting people and debriefing hospital teams, Dr. Wocial added. Palliative care professionals are also skilled at facilitating goals of care conversations with patients and families and can support hospitalists through coaching and joint family meetings.

“It’s about raising your sense of agency in your job – what in your practice you can control. People need to be able to talk frankly about it. Some managers say to clinicians: ‘Just buck up,’ while others are doing a fabulous job of offering support to their staff,” Dr. Wocial said. Hospitalists have to be willing to say when they’ve had too much. “You may not get help when you first ask for it. Be persistent. Asking for help doesn’t make you weak.”

Most doctors have their own strategies for managing stress on the job, Dr. Wachter noted. “What makes it a little easier is not having to do it alone. Many find solace in community, but community has been constrained by this pandemic. You can’t just go out for a beer after work anymore. So what are other ways to let off steam?”

The people leading hospitalist programs need to work harder at creating community and empathy when the tools allowing people to get together are somewhat limited. “Everybody is tired of Zoom,” he said. “One thing I learned as a manager was to just send messages to people acknowledging that I know this is hard. Try to think from the lens of other people and what they would find useful.”

The pandemic has been terribly unpredictable, Dr. Wachter added, but it won’t go on forever. For some doctors, yoga or mindfulness meditation may be very comforting. “For me, that’s not what I do. Golf or a good Seinfeld episode works for me.”

SHM’s Wellbeing Taskforce has created a “Hospital Medicine COVID Check-in Guide for Self & Peers” to promote both sharing and support for one another. It can be found at SHM’s Wellbeing webpage [www.hospitalmedicine.org/practice-management/wellbeing/]. The Taskforce believes that sharing common stressors as hospitalists can be healing, said its chair, Sarah Richards, MD, assistant professor of medicine at the University of Nebraska, Omaha. “This is especially true in situations where we feel we can’t provide the type of care we know our patients deserve.”
 

Respect, advocacy, self-care

Dr. Asken encouraged clinicians to focus on the efforts they are making on the job, not just the outcomes. “If someone has done their absolute best in a given circumstance, satisfaction and solace needs to be taken from that,” he said.

“Ongoing support group meetings, which we have called frontline support groups, should occur on a regular basis. Designated for physicians on the medical floors and in critical care units who are directly involved with COVID patients, these provide a brief respite but also engagement, sharing, and strengthening of mutual support.”

A lot of these issues have a fundamental thread, which comes down to respect, Dr. Barnes said. “Hospitalists need to hear their hospital administrators say: ‘I hear what you’re saying [about a problem]. Let’s think together about how to solve it.’ We need to work on being clear, and we need to speak up for what’s right. If you aren’t comfortable doing things you are being asked to do in the hospital, maybe you’re not working in the right place.”

Some efforts in the area of wellness and self-care really are helpful, Dr. Barnes said. “But you can’t exercise you way through a health system that doesn’t respect you. You need to get out of the mindset that you have no ability to make things different. We are not powerless as doctors. We can do a lot, actually. Physicians need to take ownership. If you are a hospitalist and you’re not part of any local or state or national organization that advocates for physicians, you should be.”
 

References

1. Dzeng L and Wachter RM. Ethics in conflict: Moral distress as a root cause of burnout. J Gen Intern Med. 2020 Feb;35(2):409-11. doi: 10.1007/s11606-019-05505-6.

2. Jameton A, Nursing Practice: The ethical issues. Prentice Hall Series in the Philosophy of Medicine. 1984, Englewood Cliffs, N.J.: Prentice Hall.

3. Wocial LD et al. Factors associated with physician moral distress caring for hospitalized elderly patients needing a surrogate decision-maker: A prospective study. J Gen Intern Med. 2020 May;35(5):1405-12. doi: 10.1007/s11606-020-05652-1.

4. Asken MJ. It’s not moral injury: It’s burnout (or something else). Medical Economics; June 7, 2019.

5. Asken MJ. Now it is moral injury: The COVID-19 pandemic and moral distress. Medical Economics; April 29, 2020.

The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.

Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.

The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.

The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..

“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
 

Disproportionate rate of hospitalization, DKA among Black patients

Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.

Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.

However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).

Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.

The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.

The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.

“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.

One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.

The registry remains open.

The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.

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

The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.

Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.

The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.

The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..

“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
 

Disproportionate rate of hospitalization, DKA among Black patients

Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.

Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.

However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).

Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.

The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.

The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.

“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.

One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.

The registry remains open.

The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.

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

The majority of children with type 1 diabetes who tested positive for SARS-CoV-2 were cared for at home and did well, according to the first report of outcomes of pediatric patients with type 1 diabetes and COVID-19 from the United States.

Most children who were hospitalized had diabetic ketoacidosis (DKA) and high hemoglobin A1c levels, the new report from the T1D Exchange Quality Improvement Collaborative indicates. Fewer than 2% required respiratory support, and no deaths were recorded.

The greatest risk for adverse COVID-19 outcomes was among children with A1c levels >9%. In addition, children of certain ethnic minority groups and those with public health insurance were more likely to be hospitalized.

The study, conducted by G. Todd Alonso, MD, of the University of Colorado, Barbara Davis Center, Aurora, and colleagues, was published online April 14 in the Journal of Diabetes..

“As early reports identified diabetes as a risk factor for increased morbidity and mortality with COVID-19, the findings from this surveillance study should provide measured reassurance for families of children with type 1 diabetes as well as pediatric endocrinologists and their care teams,” say Dr. Alonso and colleagues.
 

Disproportionate rate of hospitalization, DKA among Black patients

Initiated in April 2020, the T1D Exchange Quality Improvement Collaborative comprises 56 diabetes centers, of which 52 submitted a total of 266 cases involving patients younger than 19 years who had type 1 diabetes and who tested positive for SARS-CoV-2 infection. Those with new-onset type 1 diabetes were excluded from this analysis and were reported separately. The data were collected between April 9, 2020, and Jan. 15, 2021.

Of the 266 patients, 23% (61) were hospitalized, and 205 were not. There were no differences by age, gender, or diabetes duration.

However, those hospitalized were more likely to be Black (34% vs. 13% among White patients; P < .001) and to have public health insurance (64% vs. 41%; P < .001). They also had higher A1c levels than patients who were not hospitalized (11% vs. 8.2%; P < .001), and fewer used insulin pumps (26% vs. 54%; P < .001) and continuous glucose monitors (39% vs. 75%; P < .001).

Those hospitalized were also more likely to have hyperglycemia (48% vs. 28%; P = .007), nausea (33% vs. 6%; P < .001), and vomiting (49% vs. 3%; P < .001). Rates of dry cough, excess fatigue, and body aches/headaches did not differ between those hospitalized and those who remained at home.

The most common adverse outcome was DKA, which occurred in 72% (44) of those hospitalized.

The most recent A1c level was less than 9% in 82% of those hospitalized vs. 31% of those who weren’t (P < .001) and in 38 of the 44 (86%) who had DKA.

“Our data reveal a disproportionate rate of hospitalization and DKA among racial and ethnic minority groups, children who were publicly insured, and those with higher A1c. It is essential to find pathways for the most vulnerable patients to have adequate, equitable access to medical care via in person and telehealth services, to obtain and successfully use diabetes technology, and to optimize sick day management,” say Dr. Alonso and colleagues.

One child, a 15-year-old White boy, underwent intubation and was placed on a ventilator. His most recent A1c was 8.9%. Another child, a 13-year-old boy whose most recent A1c level was 11.1%, developed multisystem inflammatory syndrome of childhood.

The registry remains open.

The T1D Exchange QI Collaborative is funded by the Helmsley Charitable Trust. The T1D Exchange received partial financial support for this study from Abbott Diabetes, Dexcom, Medtronic, Insulet Corporation, JDRF, Eli Lilly, and Tandem Diabetes Care. None of the sponsors were involved in initiating, designing, or preparing the manuscript for this study.

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

Potential advantages of a neoadjuvant systemic therapy approach including downstaging of the primary breast tumor and axilla, as well the ability to assess tumor response which can have prognostic and adjuvant therapy implications. Samiei and colleagues performed a systematic review and meta-analysis of 33 studies (57,531 patients) in the neoadjuvant setting to assess axillary pathologic complete response (pCR) rates among clinically node-positive breast cancer of various subtypes. HR-negative/HER2-positive subtype was associated with the highest pCR rate (60%) followed by 59% for HER2-positive, 48% for triple-negative, 45% for HR+/HER2-positive, 35% for luminal B, 18% for HR+/HER2-negative, and 13% for luminal A. Achievement of axillary pCR after pre-operative chemotherapy has been associated with improvement in relapse-free survival and overall survival. Furthermore, this data stimulates consideration of less invasive axillary staging in certain patients pending chemotherapy response, and the contribution of breast cancer subtype and impact on outcomes deserves further investigation.

Chemotherapy-induced alopecia (CIA) during breast cancer treatment can affect an individual’s perception of their own appearance, body image, overall health and therefore may impact quality of life. Wang et al performed a meta-analysis including 27 studies with 2,202 participants and demonstrated a 61% effectiveness rate of scalp cooling to protect hair loss. The effectiveness rates of scalp cooling when taxanes and anthracyclines were used alone were higher compared to combination therapy (74% for taxanes, 66% for anthracyclines, and 54% for combination). A prospective study including 139 patients treated with anthracycline chemotherapy for breast cancer receiving scalp cooling found a 43% success rate (hair loss £50%). It is important to consider chemotherapy regimen, side effects (headache, dizziness, pain, nausea), resources and cost when counseling patients regarding scalp cooling. Future studies exploring ways to address these potential challenges will be beneficial to improve patient access and tolerance to scalp cooling.

Obesity is associated with increased risk of various types of cancers, and can have a detrimental effect on cancer prognosis as well as treatment response and tolerance. Potential mechanisms to explain the relationship between obesity, physical activity and breast cancer prognosis include increased levels of sex and metabolic hormones, alteration in adipokine levels, and increased inflammation, oxidative stress and angiogenesis. A retrospective cohort study including 6,481 patients with an initial non-metastatic breast cancer diagnosis, majority of whom were overweight (33.4%) or obese (33.8%), observed increasing BMI (for every 5 kg/m² BMI increase) was associated with an increased risk of second cancer development (7%, RR=1.07; p=0.01), obesity-related cancer (13%, RR=1.13; p<0.001), second breast cancer (11%, RR=1.11; p0.01) and second ER-positive breast cancer (15%, RR1.15; p0.008). There are several ongoing clinical trials that are examining the impact of diet and weight loss interventions on breast cancer outcomes (DIANA-5, B-AHEAD3, Breast Cancer Weight Loss Study). These studies will be key to counseling and empowering patients to address potentially modifiable variables that can positively impact their health.

References:

Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O’Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldengerg DM, Sharkey RM, Maliakel P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/ HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020;31:1709-1718.

Mougalian SS, Hernandez M, Lei X, Lynch S, Kuerer HM, Symmans WF, Theriault RL, Fornage BD, Hsu L, Buchholz TA, Sahin AA, Hunt KK, Yang WT, Hortobagyi GN, Valero V. Ten-year outcomes of patients with breast cancer with cytologically confirmed axillary lymph node metastases and pathologic complete response after primary systemic chemotherapy. JAMA Oncol. 2016;2:508-516.

Munzone M, Bagnardi V, Campennì G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines. Br J Cancer. 2019;121:325–331.

McTiernan A. Weight, physical activity and breast cancer survival. Proc Nutr Soc. 2018;77:403–411.

Potential advantages of a neoadjuvant systemic therapy approach including downstaging of the primary breast tumor and axilla, as well the ability to assess tumor response which can have prognostic and adjuvant therapy implications. Samiei and colleagues performed a systematic review and meta-analysis of 33 studies (57,531 patients) in the neoadjuvant setting to assess axillary pathologic complete response (pCR) rates among clinically node-positive breast cancer of various subtypes. HR-negative/HER2-positive subtype was associated with the highest pCR rate (60%) followed by 59% for HER2-positive, 48% for triple-negative, 45% for HR+/HER2-positive, 35% for luminal B, 18% for HR+/HER2-negative, and 13% for luminal A. Achievement of axillary pCR after pre-operative chemotherapy has been associated with improvement in relapse-free survival and overall survival. Furthermore, this data stimulates consideration of less invasive axillary staging in certain patients pending chemotherapy response, and the contribution of breast cancer subtype and impact on outcomes deserves further investigation.

Chemotherapy-induced alopecia (CIA) during breast cancer treatment can affect an individual’s perception of their own appearance, body image, overall health and therefore may impact quality of life. Wang et al performed a meta-analysis including 27 studies with 2,202 participants and demonstrated a 61% effectiveness rate of scalp cooling to protect hair loss. The effectiveness rates of scalp cooling when taxanes and anthracyclines were used alone were higher compared to combination therapy (74% for taxanes, 66% for anthracyclines, and 54% for combination). A prospective study including 139 patients treated with anthracycline chemotherapy for breast cancer receiving scalp cooling found a 43% success rate (hair loss £50%). It is important to consider chemotherapy regimen, side effects (headache, dizziness, pain, nausea), resources and cost when counseling patients regarding scalp cooling. Future studies exploring ways to address these potential challenges will be beneficial to improve patient access and tolerance to scalp cooling.

Obesity is associated with increased risk of various types of cancers, and can have a detrimental effect on cancer prognosis as well as treatment response and tolerance. Potential mechanisms to explain the relationship between obesity, physical activity and breast cancer prognosis include increased levels of sex and metabolic hormones, alteration in adipokine levels, and increased inflammation, oxidative stress and angiogenesis. A retrospective cohort study including 6,481 patients with an initial non-metastatic breast cancer diagnosis, majority of whom were overweight (33.4%) or obese (33.8%), observed increasing BMI (for every 5 kg/m² BMI increase) was associated with an increased risk of second cancer development (7%, RR=1.07; p=0.01), obesity-related cancer (13%, RR=1.13; p<0.001), second breast cancer (11%, RR=1.11; p0.01) and second ER-positive breast cancer (15%, RR1.15; p0.008). There are several ongoing clinical trials that are examining the impact of diet and weight loss interventions on breast cancer outcomes (DIANA-5, B-AHEAD3, Breast Cancer Weight Loss Study). These studies will be key to counseling and empowering patients to address potentially modifiable variables that can positively impact their health.

References:

Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O’Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldengerg DM, Sharkey RM, Maliakel P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/ HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020;31:1709-1718.

Mougalian SS, Hernandez M, Lei X, Lynch S, Kuerer HM, Symmans WF, Theriault RL, Fornage BD, Hsu L, Buchholz TA, Sahin AA, Hunt KK, Yang WT, Hortobagyi GN, Valero V. Ten-year outcomes of patients with breast cancer with cytologically confirmed axillary lymph node metastases and pathologic complete response after primary systemic chemotherapy. JAMA Oncol. 2016;2:508-516.

Munzone M, Bagnardi V, Campennì G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines. Br J Cancer. 2019;121:325–331.

McTiernan A. Weight, physical activity and breast cancer survival. Proc Nutr Soc. 2018;77:403–411.

Potential advantages of a neoadjuvant systemic therapy approach including downstaging of the primary breast tumor and axilla, as well the ability to assess tumor response which can have prognostic and adjuvant therapy implications. Samiei and colleagues performed a systematic review and meta-analysis of 33 studies (57,531 patients) in the neoadjuvant setting to assess axillary pathologic complete response (pCR) rates among clinically node-positive breast cancer of various subtypes. HR-negative/HER2-positive subtype was associated with the highest pCR rate (60%) followed by 59% for HER2-positive, 48% for triple-negative, 45% for HR+/HER2-positive, 35% for luminal B, 18% for HR+/HER2-negative, and 13% for luminal A. Achievement of axillary pCR after pre-operative chemotherapy has been associated with improvement in relapse-free survival and overall survival. Furthermore, this data stimulates consideration of less invasive axillary staging in certain patients pending chemotherapy response, and the contribution of breast cancer subtype and impact on outcomes deserves further investigation.

Chemotherapy-induced alopecia (CIA) during breast cancer treatment can affect an individual’s perception of their own appearance, body image, overall health and therefore may impact quality of life. Wang et al performed a meta-analysis including 27 studies with 2,202 participants and demonstrated a 61% effectiveness rate of scalp cooling to protect hair loss. The effectiveness rates of scalp cooling when taxanes and anthracyclines were used alone were higher compared to combination therapy (74% for taxanes, 66% for anthracyclines, and 54% for combination). A prospective study including 139 patients treated with anthracycline chemotherapy for breast cancer receiving scalp cooling found a 43% success rate (hair loss £50%). It is important to consider chemotherapy regimen, side effects (headache, dizziness, pain, nausea), resources and cost when counseling patients regarding scalp cooling. Future studies exploring ways to address these potential challenges will be beneficial to improve patient access and tolerance to scalp cooling.

Obesity is associated with increased risk of various types of cancers, and can have a detrimental effect on cancer prognosis as well as treatment response and tolerance. Potential mechanisms to explain the relationship between obesity, physical activity and breast cancer prognosis include increased levels of sex and metabolic hormones, alteration in adipokine levels, and increased inflammation, oxidative stress and angiogenesis. A retrospective cohort study including 6,481 patients with an initial non-metastatic breast cancer diagnosis, majority of whom were overweight (33.4%) or obese (33.8%), observed increasing BMI (for every 5 kg/m² BMI increase) was associated with an increased risk of second cancer development (7%, RR=1.07; p=0.01), obesity-related cancer (13%, RR=1.13; p<0.001), second breast cancer (11%, RR=1.11; p0.01) and second ER-positive breast cancer (15%, RR1.15; p0.008). There are several ongoing clinical trials that are examining the impact of diet and weight loss interventions on breast cancer outcomes (DIANA-5, B-AHEAD3, Breast Cancer Weight Loss Study). These studies will be key to counseling and empowering patients to address potentially modifiable variables that can positively impact their health.

References:

Kalinsky K, Diamond JR, Vahdat LT, Tolaney SM, Juric D, O’Shaughnessy J, Moroose RL, Mayer IA, Abramson VG, Goldengerg DM, Sharkey RM, Maliakel P, Hong Q, Goswami T, Wegener WA, Bardia A. Sacituzumab govitecan in previously treated hormone receptor-positive/ HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020;31:1709-1718.

Mougalian SS, Hernandez M, Lei X, Lynch S, Kuerer HM, Symmans WF, Theriault RL, Fornage BD, Hsu L, Buchholz TA, Sahin AA, Hunt KK, Yang WT, Hortobagyi GN, Valero V. Ten-year outcomes of patients with breast cancer with cytologically confirmed axillary lymph node metastases and pathologic complete response after primary systemic chemotherapy. JAMA Oncol. 2016;2:508-516.

Munzone M, Bagnardi V, Campennì G, Mazzocco K, Pagan E, Tramacere A, Masiero M, Iorfida M, Mazza M, Montagna E, Cancello G, Bianco N, Palazzo A, Cardillo A, Dellapasqua S, Sangalli C, Pettini G, Pravettoni G, Colleoni M, Veronesi P. Preventing chemotherapy-induced alopecia: a prospective clinical trial on the efficacy and safety of a scalp-cooling system in early breast cancer patients treated with anthracyclines. Br J Cancer. 2019;121:325–331.

McTiernan A. Weight, physical activity and breast cancer survival. Proc Nutr Soc. 2018;77:403–411.