The incidence and prevalence of IgG4-related disease each rose considerably from 2015 to 2019 in the United States, and the risk of death in those with the immune-mediated condition is about 2.5 times higher than those who are not affected, based on an analysis of claims data from commercially insured adults.

The first population-based study of IgG4-RD incidence, prevalence, and mortality establishes “key benchmarks for informing the diagnosis and management of patients” with a condition “that causes fibrosing inflammatory lesions at nearly any anatomic site,” and wasn’t initially described until 2001, Zachary S. Wallace, MD, and associates said in Annals of the Rheumatic Diseases.

The increases in incidence and prevalence likely reflected increased disease awareness, they suggested. Overall U.S. incidence was 1.2 per 100,000 person-years for the 5-year period of 2015-2019, rising 86% from 0.78 per 100,000 person-years to 1.45 in 2018 before dropping to 1.39 in 2019. The change in prevalence was even greater, increasing 122% from 2.41 per 100,000 persons in 2015 to 5.34 per 100,000 in 2019, the investigators said.

Previous studies had indicated that the majority of patients with IgG4-RD were male, but the current study, using Optum’s Clinformatics Data Mart, which includes commercial health plan and Medicare Advantage members in all 50 states, showed that both incidence and prevalence (see graph) were higher among women, noted Dr. Wallace of Massachusetts General Hospital, Boston, and associates. They identified 524 patients (57.6% female) in the database who met the criteria for IgG4-RD from Jan. 1, 2010, to Dec. 31, 2019.

Incidence over the course of the study “was similar in patients identified as Asian or White but lower in those identified as Black or Hispanic,” they noted, adding that “the prevalence of IgG4-RD during this period reflected similar trends.” A jump in prevalence from 2018 to 2019, however, left White patients with a much higher rate (6.13 per 100,000 persons) than Asian patients (4.54 per 100,000), Black patients (3.42), and Hispanic patients (3.02).

For the mortality analysis, 516 patients with IgG4-RD were age-, sex-, and race-matched with 5,160 patients without IgG4-RD. Mortality was 3.42 and 1.46 per 100 person-years, respectively, over the 5.5 years of follow-up, so IgG4-RD was associated with a 2.5-fold higher risk of death. “The association of IgG4-RD with a higher risk of death was observed across the age spectrum and among both male and female patients,” the researchers said.

The incidence and prevalence of IgG4-related disease each rose considerably from 2015 to 2019 in the United States, and the risk of death in those with the immune-mediated condition is about 2.5 times higher than those who are not affected, based on an analysis of claims data from commercially insured adults.

The first population-based study of IgG4-RD incidence, prevalence, and mortality establishes “key benchmarks for informing the diagnosis and management of patients” with a condition “that causes fibrosing inflammatory lesions at nearly any anatomic site,” and wasn’t initially described until 2001, Zachary S. Wallace, MD, and associates said in Annals of the Rheumatic Diseases.

The increases in incidence and prevalence likely reflected increased disease awareness, they suggested. Overall U.S. incidence was 1.2 per 100,000 person-years for the 5-year period of 2015-2019, rising 86% from 0.78 per 100,000 person-years to 1.45 in 2018 before dropping to 1.39 in 2019. The change in prevalence was even greater, increasing 122% from 2.41 per 100,000 persons in 2015 to 5.34 per 100,000 in 2019, the investigators said.

Previous studies had indicated that the majority of patients with IgG4-RD were male, but the current study, using Optum’s Clinformatics Data Mart, which includes commercial health plan and Medicare Advantage members in all 50 states, showed that both incidence and prevalence (see graph) were higher among women, noted Dr. Wallace of Massachusetts General Hospital, Boston, and associates. They identified 524 patients (57.6% female) in the database who met the criteria for IgG4-RD from Jan. 1, 2010, to Dec. 31, 2019.

Incidence over the course of the study “was similar in patients identified as Asian or White but lower in those identified as Black or Hispanic,” they noted, adding that “the prevalence of IgG4-RD during this period reflected similar trends.” A jump in prevalence from 2018 to 2019, however, left White patients with a much higher rate (6.13 per 100,000 persons) than Asian patients (4.54 per 100,000), Black patients (3.42), and Hispanic patients (3.02).

For the mortality analysis, 516 patients with IgG4-RD were age-, sex-, and race-matched with 5,160 patients without IgG4-RD. Mortality was 3.42 and 1.46 per 100 person-years, respectively, over the 5.5 years of follow-up, so IgG4-RD was associated with a 2.5-fold higher risk of death. “The association of IgG4-RD with a higher risk of death was observed across the age spectrum and among both male and female patients,” the researchers said.

The incidence and prevalence of IgG4-related disease each rose considerably from 2015 to 2019 in the United States, and the risk of death in those with the immune-mediated condition is about 2.5 times higher than those who are not affected, based on an analysis of claims data from commercially insured adults.

The first population-based study of IgG4-RD incidence, prevalence, and mortality establishes “key benchmarks for informing the diagnosis and management of patients” with a condition “that causes fibrosing inflammatory lesions at nearly any anatomic site,” and wasn’t initially described until 2001, Zachary S. Wallace, MD, and associates said in Annals of the Rheumatic Diseases.

The increases in incidence and prevalence likely reflected increased disease awareness, they suggested. Overall U.S. incidence was 1.2 per 100,000 person-years for the 5-year period of 2015-2019, rising 86% from 0.78 per 100,000 person-years to 1.45 in 2018 before dropping to 1.39 in 2019. The change in prevalence was even greater, increasing 122% from 2.41 per 100,000 persons in 2015 to 5.34 per 100,000 in 2019, the investigators said.

Previous studies had indicated that the majority of patients with IgG4-RD were male, but the current study, using Optum’s Clinformatics Data Mart, which includes commercial health plan and Medicare Advantage members in all 50 states, showed that both incidence and prevalence (see graph) were higher among women, noted Dr. Wallace of Massachusetts General Hospital, Boston, and associates. They identified 524 patients (57.6% female) in the database who met the criteria for IgG4-RD from Jan. 1, 2010, to Dec. 31, 2019.

Incidence over the course of the study “was similar in patients identified as Asian or White but lower in those identified as Black or Hispanic,” they noted, adding that “the prevalence of IgG4-RD during this period reflected similar trends.” A jump in prevalence from 2018 to 2019, however, left White patients with a much higher rate (6.13 per 100,000 persons) than Asian patients (4.54 per 100,000), Black patients (3.42), and Hispanic patients (3.02).

For the mortality analysis, 516 patients with IgG4-RD were age-, sex-, and race-matched with 5,160 patients without IgG4-RD. Mortality was 3.42 and 1.46 per 100 person-years, respectively, over the 5.5 years of follow-up, so IgG4-RD was associated with a 2.5-fold higher risk of death. “The association of IgG4-RD with a higher risk of death was observed across the age spectrum and among both male and female patients,” the researchers said.

The U.S. Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.

The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.

The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.

When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.

“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
 

Insurance access

Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.

But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit. 

Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.

Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
 

Uncertainties persist

The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.

The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).

The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.

The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.

“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.

The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.

One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.

“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.

The task force will accept comments from the public on this draft update through June 5.

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

The U.S. Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.

The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.

The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.

When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.

“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
 

Insurance access

Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.

But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit. 

Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.

Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
 

Uncertainties persist

The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.

The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).

The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.

The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.

“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.

The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.

One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.

“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.

The task force will accept comments from the public on this draft update through June 5.

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

The U.S. Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.

The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.

The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.

When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.

“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
 

Insurance access

Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.

But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit. 

Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.

Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
 

Uncertainties persist

The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.

The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).

The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.

The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.

“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.

The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.

One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.

“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.

The task force will accept comments from the public on this draft update through June 5.

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

Are there clinically significant differences between axial spondyloarthritis with psoriasis and psoriatic arthritis with axial symptoms? Does it matter?

It all depends on whom you ask, but right now the evidence seems to be tipping in favor of the “splitters” who cite evidence supporting their contention that axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS) with psoriasis and psoriatic arthritis (PsA) with axial symptoms are distinct clinical entities that require more precise diagnosis and treatment.

“Lumpers,” in contrast, argue that they are different points on the same clinical spectrum.

The debate is not just of academic interest, but has real consequences for patients, say specialists on both sides of the aisle.
 

Overlapping features, different presentations

“Axial SpA and axPsA have overlapping features but also meaningful differences in genetics, clinical presentation, imaging, and immunophenotype. Efforts are underway to develop classification criteria for axPsA to aid research efforts as well as clinical diagnosis and management,” Philip J. Mease, MD, director of rheumatology research at Swedish Medical Center/Providence–St. Joseph Health in Seattle, and colleagues contend.

In an editorial published in the International Journal of Rheumatic Diseases, Dr. Mease and colleagues noted that, although HLA-B*27 is a genetic risk factor for both axPsA and axSpA, some HLA-B alleles are significantly associated with axPsA, whereas other alleles are associated with axSpA.

In addition, while genes in the interleukin-23 and IL-17 pathway are associated with increased risk for axSpA, genes in the IL-13 pathway have been identified as risk markers for axPsA, they noted.
 

Two cohorts better than one?

Dafna Gladman, MD, professor of medicine at the University of Toronto and senior scientist at the Schroeder Arthritis Institute at Toronto Western Hospital, and colleagues have a unique perspective on the similarities and differences between the disease entities.

Her group’s research uses data on cohorts of patients treated in two separate clinics at Toronto Western Hospital: one for patients with PsA, and one for patients with axial spondyloarthritis, including those with ankylosing spondylitis, nonradiographic axSpA, and spondylitis associated with inflammatory bowel disease.

“Our work has shown that there are differences, and one of the reasons that it’s now important is that the anti–IL-23 medications, both the IL-12/23 inhibitor ustekinumab [Stelara] and the IL-23 inhibitor guselkumab [Tremfya] work for psoriatic arthritis, whereas IL-23 did not work in ankylosing spondylitis, so that provided further impetus to look into the distinction between the two groups,” Dr. Gladman said in an interview.

Dr. Gladman and colleagues published a study in Rheumatology in which they compared clinical presentations and features of patients with AS with or without psoriasis with patients with axPsA.

They found that patients with AS with or without psoriasis tended to be younger, had a higher proportion of males to females, and were more likely to be positive for HLA-B*27. Patients with AS also had more back pain at presentation, worse axial disease activity scores, worse global assessments by physicians, and higher grades of sacroiliitis, and they were more likely to be taking biologic agents.

“What that showed, right off the top, that whether we’re looking at the total group or we’re looking specifically at those patients who have psoriasis or don’t have psoriasis, they are different from those with psoriatic arthritis with axial disease,” she said.

They concluded that “axPsA seems to be a distinct entity.”
 

Two clinics, same presentation

Because the aforementioned study included all patients with PsA with or without peripheral disease, the investigators decided to filter out some of the background noise and conduct a second study in which they compared patients who presented to the two clinics with the same presentation, either with spinal disease and psoriasis to the spondylitis clinic, or with psoriasis and isolated axial disease to the PsA clinic.

The results, published in Annals of the Rheumatic Diseases, showed that just 2.03% of patients with PsA had isolated axial disease, and an additional 29.38% had axial and peripheral disease.

In this study, “you can see that even in that group there are distinct differences. The patients that are labeled psoriatic spondylitis are different from those that are labeled ankylosing spondylitis with psoriasis,” Dr. Gladman said.

Isolated axial disease in patients with PsA was associated with HLA-B*27 positivity and lower Health Assessment Questionnaire scores. In addition, patients who were HLA-B*27 positive also had a nearly eightfold higher risk for developing peripheral disease over time.

Patients with isolated axial PsA were significantly more likely to be diagnosed at an older age (mean, 37.44 vs. 29.65 years), had higher Psoriasis Area Severity Index scores and a higher likelihood of having psoriatic nail lesions than patients with AS with isolated axial disease and psoriasis.

In contrast, patients with isolated axSpA with psoriasis were more likely to have inflammatory back pain, spinal pain, joint pain/swelling, and areas of localized tenderness, and they had greater severity of morning stiffness.

Dr. Gladman noted that, although AS and PsA are associated with the same gene that encodes for the IL-23 receptor, each condition is associated with a different single-nucleotide polymorphism.

Same disease, different flavors?

But as Mark Twain said, it is difference of opinion that makes horse races, and some specialists in rheumatology say that axSpA amd axPsA are just two sides of the same coin.

Pramod Rathod

“There are always different schools of thought. I believe that they are not different diseases, but a spectrum of diseases,” said Shailendra Singh, MD, a rheumatologist at Unity Health Medical Center in Searcy, Ark., and past president of the Arkansas Rheumatology Association.

In an interview, Dr. Singh said that the spectrum ranges from diseases with primarily axial involvement, such as AS, to those with primarily peripheral involvement, such as reactive arthritis.

He pointed out that these conditions have overlapping symptoms, including enthesitis, dactylitis, and uveitis, and inflammatory arthritis.

Daniel Wendling, MD, PhD, from the Centre Hospitalier Régional Universitaire de Besançon (France), Université de Franche-Comté, and colleagues agreed.

“The criteria currently available for both SpA [ASAS (Assessment of Spondyloarthritis International Society) criteria] and PsA [CASPAR (Classification for Psoriatic Arthritis) criteria] are classification criteria, not diagnostic criteria. They are not very stringent and are not exclusive. Thus, the same patient can easily be classified simultaneously in both entities, making the distinction between axSpA with psoriasis and axPsA theoretical,” they wrote in an editorial published in Joint Bone Spine.

They cited as an example of the allegedly fuzzy criteria a prospective study conducted by the investigators in Bath, England, in which modified New York criteria for AS were met by 24% of patients with AS, and CASPAR criteria for PsA were met by an equal number of patients with AS.
 

Therapeutic implications

Dr. Wendling and colleagues acknowledge the differences cited in studies by Dr. Gladman, Dr. Mease, and others between patients with axPsA and those with axSpA, but argue that the differences are not that great and not so clear.

“It should also be emphasized that, although some differences between axPsA and axSpA reach statistical significance, they are mostly at the margin, with low odd ratios,” they wrote.

“It is also important to consider the variability in the definition of axPsA, sometimes simply ‘physician reported’ and elsewhere based on the modified New York radiographic criteria; the latter are only present late in the course of the disease, and this may induce bias,” they continued.

Dr. Singh agreed that, as noted by Dr. Gladman, some patients will respond to anti–IL-17, anti–IL-23, and anti–IL-12/23 agents, whereas others will have better responses with tumor necrosis factor (TNF) inhibitors, and still others, such as those with peripheral involvement in the hands and feet may fare better with nonbiologic disease-modifying antirheumatic drugs such as methotrexate.
 

Answers to come?

Dr. Gladman noted that the information available to date about the efficacy of IL-23 inhibition in axPsA is based on a post hoc analysis of the PSUMMIT 1 and 2 controlled trials in PsA, and is not definitive.

The randomized, controlled STAR trial, currently recruiting patients, is designed to see whether guselkumab can reduce axial symptoms and inflammation in patients with active axPsA.

“What I say is, there is a rationale for [anti–IL-23] to work in psoriatic arthritis, and not work in ankylosing spondylitis,” she said.

In contrast, IL-17 inhibitors, anti-TNF agents, and Janus kinase inhibitors show efficacy against both axPsA and AS. Rituximab is ineffective against PsA, but has shown efficacy against AS, especially in patients with neurologic complications from anti-TNF agents.

“There may be other medications that would work more specifically in axial psoriatic arthritis that don’t work in ankylosing spondylitis, but at least recognizing that there may be some differences, and that therefore a correct diagnosis should be obtained, might be important,” she said.

Ideally, the picture will become clearer with results from the ongoing Axial Involvement in Psoriatic Arthritis cohort, a joint project of ASAS and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. The multinational, cross-sectional study is designed “to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research.”

Stay tuned.

Dr. Gladman’s research is supported by a grant from the Krembil Foundation. Dr. Singh disclosed research support from various companies. Funding sources and conflict of interest disclosures from other works cited are contained in their respective references.

Are there clinically significant differences between axial spondyloarthritis with psoriasis and psoriatic arthritis with axial symptoms? Does it matter?

It all depends on whom you ask, but right now the evidence seems to be tipping in favor of the “splitters” who cite evidence supporting their contention that axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS) with psoriasis and psoriatic arthritis (PsA) with axial symptoms are distinct clinical entities that require more precise diagnosis and treatment.

“Lumpers,” in contrast, argue that they are different points on the same clinical spectrum.

The debate is not just of academic interest, but has real consequences for patients, say specialists on both sides of the aisle.
 

Overlapping features, different presentations

“Axial SpA and axPsA have overlapping features but also meaningful differences in genetics, clinical presentation, imaging, and immunophenotype. Efforts are underway to develop classification criteria for axPsA to aid research efforts as well as clinical diagnosis and management,” Philip J. Mease, MD, director of rheumatology research at Swedish Medical Center/Providence–St. Joseph Health in Seattle, and colleagues contend.

In an editorial published in the International Journal of Rheumatic Diseases, Dr. Mease and colleagues noted that, although HLA-B*27 is a genetic risk factor for both axPsA and axSpA, some HLA-B alleles are significantly associated with axPsA, whereas other alleles are associated with axSpA.

In addition, while genes in the interleukin-23 and IL-17 pathway are associated with increased risk for axSpA, genes in the IL-13 pathway have been identified as risk markers for axPsA, they noted.
 

Two cohorts better than one?

Dafna Gladman, MD, professor of medicine at the University of Toronto and senior scientist at the Schroeder Arthritis Institute at Toronto Western Hospital, and colleagues have a unique perspective on the similarities and differences between the disease entities.

Her group’s research uses data on cohorts of patients treated in two separate clinics at Toronto Western Hospital: one for patients with PsA, and one for patients with axial spondyloarthritis, including those with ankylosing spondylitis, nonradiographic axSpA, and spondylitis associated with inflammatory bowel disease.

“Our work has shown that there are differences, and one of the reasons that it’s now important is that the anti–IL-23 medications, both the IL-12/23 inhibitor ustekinumab [Stelara] and the IL-23 inhibitor guselkumab [Tremfya] work for psoriatic arthritis, whereas IL-23 did not work in ankylosing spondylitis, so that provided further impetus to look into the distinction between the two groups,” Dr. Gladman said in an interview.

Dr. Gladman and colleagues published a study in Rheumatology in which they compared clinical presentations and features of patients with AS with or without psoriasis with patients with axPsA.

They found that patients with AS with or without psoriasis tended to be younger, had a higher proportion of males to females, and were more likely to be positive for HLA-B*27. Patients with AS also had more back pain at presentation, worse axial disease activity scores, worse global assessments by physicians, and higher grades of sacroiliitis, and they were more likely to be taking biologic agents.

“What that showed, right off the top, that whether we’re looking at the total group or we’re looking specifically at those patients who have psoriasis or don’t have psoriasis, they are different from those with psoriatic arthritis with axial disease,” she said.

They concluded that “axPsA seems to be a distinct entity.”
 

Two clinics, same presentation

Because the aforementioned study included all patients with PsA with or without peripheral disease, the investigators decided to filter out some of the background noise and conduct a second study in which they compared patients who presented to the two clinics with the same presentation, either with spinal disease and psoriasis to the spondylitis clinic, or with psoriasis and isolated axial disease to the PsA clinic.

The results, published in Annals of the Rheumatic Diseases, showed that just 2.03% of patients with PsA had isolated axial disease, and an additional 29.38% had axial and peripheral disease.

In this study, “you can see that even in that group there are distinct differences. The patients that are labeled psoriatic spondylitis are different from those that are labeled ankylosing spondylitis with psoriasis,” Dr. Gladman said.

Isolated axial disease in patients with PsA was associated with HLA-B*27 positivity and lower Health Assessment Questionnaire scores. In addition, patients who were HLA-B*27 positive also had a nearly eightfold higher risk for developing peripheral disease over time.

Patients with isolated axial PsA were significantly more likely to be diagnosed at an older age (mean, 37.44 vs. 29.65 years), had higher Psoriasis Area Severity Index scores and a higher likelihood of having psoriatic nail lesions than patients with AS with isolated axial disease and psoriasis.

In contrast, patients with isolated axSpA with psoriasis were more likely to have inflammatory back pain, spinal pain, joint pain/swelling, and areas of localized tenderness, and they had greater severity of morning stiffness.

Dr. Gladman noted that, although AS and PsA are associated with the same gene that encodes for the IL-23 receptor, each condition is associated with a different single-nucleotide polymorphism.

Same disease, different flavors?

But as Mark Twain said, it is difference of opinion that makes horse races, and some specialists in rheumatology say that axSpA amd axPsA are just two sides of the same coin.

Pramod Rathod

“There are always different schools of thought. I believe that they are not different diseases, but a spectrum of diseases,” said Shailendra Singh, MD, a rheumatologist at Unity Health Medical Center in Searcy, Ark., and past president of the Arkansas Rheumatology Association.

In an interview, Dr. Singh said that the spectrum ranges from diseases with primarily axial involvement, such as AS, to those with primarily peripheral involvement, such as reactive arthritis.

He pointed out that these conditions have overlapping symptoms, including enthesitis, dactylitis, and uveitis, and inflammatory arthritis.

Daniel Wendling, MD, PhD, from the Centre Hospitalier Régional Universitaire de Besançon (France), Université de Franche-Comté, and colleagues agreed.

“The criteria currently available for both SpA [ASAS (Assessment of Spondyloarthritis International Society) criteria] and PsA [CASPAR (Classification for Psoriatic Arthritis) criteria] are classification criteria, not diagnostic criteria. They are not very stringent and are not exclusive. Thus, the same patient can easily be classified simultaneously in both entities, making the distinction between axSpA with psoriasis and axPsA theoretical,” they wrote in an editorial published in Joint Bone Spine.

They cited as an example of the allegedly fuzzy criteria a prospective study conducted by the investigators in Bath, England, in which modified New York criteria for AS were met by 24% of patients with AS, and CASPAR criteria for PsA were met by an equal number of patients with AS.
 

Therapeutic implications

Dr. Wendling and colleagues acknowledge the differences cited in studies by Dr. Gladman, Dr. Mease, and others between patients with axPsA and those with axSpA, but argue that the differences are not that great and not so clear.

“It should also be emphasized that, although some differences between axPsA and axSpA reach statistical significance, they are mostly at the margin, with low odd ratios,” they wrote.

“It is also important to consider the variability in the definition of axPsA, sometimes simply ‘physician reported’ and elsewhere based on the modified New York radiographic criteria; the latter are only present late in the course of the disease, and this may induce bias,” they continued.

Dr. Singh agreed that, as noted by Dr. Gladman, some patients will respond to anti–IL-17, anti–IL-23, and anti–IL-12/23 agents, whereas others will have better responses with tumor necrosis factor (TNF) inhibitors, and still others, such as those with peripheral involvement in the hands and feet may fare better with nonbiologic disease-modifying antirheumatic drugs such as methotrexate.
 

Answers to come?

Dr. Gladman noted that the information available to date about the efficacy of IL-23 inhibition in axPsA is based on a post hoc analysis of the PSUMMIT 1 and 2 controlled trials in PsA, and is not definitive.

The randomized, controlled STAR trial, currently recruiting patients, is designed to see whether guselkumab can reduce axial symptoms and inflammation in patients with active axPsA.

“What I say is, there is a rationale for [anti–IL-23] to work in psoriatic arthritis, and not work in ankylosing spondylitis,” she said.

In contrast, IL-17 inhibitors, anti-TNF agents, and Janus kinase inhibitors show efficacy against both axPsA and AS. Rituximab is ineffective against PsA, but has shown efficacy against AS, especially in patients with neurologic complications from anti-TNF agents.

“There may be other medications that would work more specifically in axial psoriatic arthritis that don’t work in ankylosing spondylitis, but at least recognizing that there may be some differences, and that therefore a correct diagnosis should be obtained, might be important,” she said.

Ideally, the picture will become clearer with results from the ongoing Axial Involvement in Psoriatic Arthritis cohort, a joint project of ASAS and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. The multinational, cross-sectional study is designed “to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research.”

Stay tuned.

Dr. Gladman’s research is supported by a grant from the Krembil Foundation. Dr. Singh disclosed research support from various companies. Funding sources and conflict of interest disclosures from other works cited are contained in their respective references.

Are there clinically significant differences between axial spondyloarthritis with psoriasis and psoriatic arthritis with axial symptoms? Does it matter?

It all depends on whom you ask, but right now the evidence seems to be tipping in favor of the “splitters” who cite evidence supporting their contention that axial spondyloarthritis (axSpA)/ankylosing spondylitis (AS) with psoriasis and psoriatic arthritis (PsA) with axial symptoms are distinct clinical entities that require more precise diagnosis and treatment.

“Lumpers,” in contrast, argue that they are different points on the same clinical spectrum.

The debate is not just of academic interest, but has real consequences for patients, say specialists on both sides of the aisle.
 

Overlapping features, different presentations

“Axial SpA and axPsA have overlapping features but also meaningful differences in genetics, clinical presentation, imaging, and immunophenotype. Efforts are underway to develop classification criteria for axPsA to aid research efforts as well as clinical diagnosis and management,” Philip J. Mease, MD, director of rheumatology research at Swedish Medical Center/Providence–St. Joseph Health in Seattle, and colleagues contend.

In an editorial published in the International Journal of Rheumatic Diseases, Dr. Mease and colleagues noted that, although HLA-B*27 is a genetic risk factor for both axPsA and axSpA, some HLA-B alleles are significantly associated with axPsA, whereas other alleles are associated with axSpA.

In addition, while genes in the interleukin-23 and IL-17 pathway are associated with increased risk for axSpA, genes in the IL-13 pathway have been identified as risk markers for axPsA, they noted.
 

Two cohorts better than one?

Dafna Gladman, MD, professor of medicine at the University of Toronto and senior scientist at the Schroeder Arthritis Institute at Toronto Western Hospital, and colleagues have a unique perspective on the similarities and differences between the disease entities.

Her group’s research uses data on cohorts of patients treated in two separate clinics at Toronto Western Hospital: one for patients with PsA, and one for patients with axial spondyloarthritis, including those with ankylosing spondylitis, nonradiographic axSpA, and spondylitis associated with inflammatory bowel disease.

“Our work has shown that there are differences, and one of the reasons that it’s now important is that the anti–IL-23 medications, both the IL-12/23 inhibitor ustekinumab [Stelara] and the IL-23 inhibitor guselkumab [Tremfya] work for psoriatic arthritis, whereas IL-23 did not work in ankylosing spondylitis, so that provided further impetus to look into the distinction between the two groups,” Dr. Gladman said in an interview.

Dr. Gladman and colleagues published a study in Rheumatology in which they compared clinical presentations and features of patients with AS with or without psoriasis with patients with axPsA.

They found that patients with AS with or without psoriasis tended to be younger, had a higher proportion of males to females, and were more likely to be positive for HLA-B*27. Patients with AS also had more back pain at presentation, worse axial disease activity scores, worse global assessments by physicians, and higher grades of sacroiliitis, and they were more likely to be taking biologic agents.

“What that showed, right off the top, that whether we’re looking at the total group or we’re looking specifically at those patients who have psoriasis or don’t have psoriasis, they are different from those with psoriatic arthritis with axial disease,” she said.

They concluded that “axPsA seems to be a distinct entity.”
 

Two clinics, same presentation

Because the aforementioned study included all patients with PsA with or without peripheral disease, the investigators decided to filter out some of the background noise and conduct a second study in which they compared patients who presented to the two clinics with the same presentation, either with spinal disease and psoriasis to the spondylitis clinic, or with psoriasis and isolated axial disease to the PsA clinic.

The results, published in Annals of the Rheumatic Diseases, showed that just 2.03% of patients with PsA had isolated axial disease, and an additional 29.38% had axial and peripheral disease.

In this study, “you can see that even in that group there are distinct differences. The patients that are labeled psoriatic spondylitis are different from those that are labeled ankylosing spondylitis with psoriasis,” Dr. Gladman said.

Isolated axial disease in patients with PsA was associated with HLA-B*27 positivity and lower Health Assessment Questionnaire scores. In addition, patients who were HLA-B*27 positive also had a nearly eightfold higher risk for developing peripheral disease over time.

Patients with isolated axial PsA were significantly more likely to be diagnosed at an older age (mean, 37.44 vs. 29.65 years), had higher Psoriasis Area Severity Index scores and a higher likelihood of having psoriatic nail lesions than patients with AS with isolated axial disease and psoriasis.

In contrast, patients with isolated axSpA with psoriasis were more likely to have inflammatory back pain, spinal pain, joint pain/swelling, and areas of localized tenderness, and they had greater severity of morning stiffness.

Dr. Gladman noted that, although AS and PsA are associated with the same gene that encodes for the IL-23 receptor, each condition is associated with a different single-nucleotide polymorphism.

Same disease, different flavors?

But as Mark Twain said, it is difference of opinion that makes horse races, and some specialists in rheumatology say that axSpA amd axPsA are just two sides of the same coin.

Pramod Rathod

“There are always different schools of thought. I believe that they are not different diseases, but a spectrum of diseases,” said Shailendra Singh, MD, a rheumatologist at Unity Health Medical Center in Searcy, Ark., and past president of the Arkansas Rheumatology Association.

In an interview, Dr. Singh said that the spectrum ranges from diseases with primarily axial involvement, such as AS, to those with primarily peripheral involvement, such as reactive arthritis.

He pointed out that these conditions have overlapping symptoms, including enthesitis, dactylitis, and uveitis, and inflammatory arthritis.

Daniel Wendling, MD, PhD, from the Centre Hospitalier Régional Universitaire de Besançon (France), Université de Franche-Comté, and colleagues agreed.

“The criteria currently available for both SpA [ASAS (Assessment of Spondyloarthritis International Society) criteria] and PsA [CASPAR (Classification for Psoriatic Arthritis) criteria] are classification criteria, not diagnostic criteria. They are not very stringent and are not exclusive. Thus, the same patient can easily be classified simultaneously in both entities, making the distinction between axSpA with psoriasis and axPsA theoretical,” they wrote in an editorial published in Joint Bone Spine.

They cited as an example of the allegedly fuzzy criteria a prospective study conducted by the investigators in Bath, England, in which modified New York criteria for AS were met by 24% of patients with AS, and CASPAR criteria for PsA were met by an equal number of patients with AS.
 

Therapeutic implications

Dr. Wendling and colleagues acknowledge the differences cited in studies by Dr. Gladman, Dr. Mease, and others between patients with axPsA and those with axSpA, but argue that the differences are not that great and not so clear.

“It should also be emphasized that, although some differences between axPsA and axSpA reach statistical significance, they are mostly at the margin, with low odd ratios,” they wrote.

“It is also important to consider the variability in the definition of axPsA, sometimes simply ‘physician reported’ and elsewhere based on the modified New York radiographic criteria; the latter are only present late in the course of the disease, and this may induce bias,” they continued.

Dr. Singh agreed that, as noted by Dr. Gladman, some patients will respond to anti–IL-17, anti–IL-23, and anti–IL-12/23 agents, whereas others will have better responses with tumor necrosis factor (TNF) inhibitors, and still others, such as those with peripheral involvement in the hands and feet may fare better with nonbiologic disease-modifying antirheumatic drugs such as methotrexate.
 

Answers to come?

Dr. Gladman noted that the information available to date about the efficacy of IL-23 inhibition in axPsA is based on a post hoc analysis of the PSUMMIT 1 and 2 controlled trials in PsA, and is not definitive.

The randomized, controlled STAR trial, currently recruiting patients, is designed to see whether guselkumab can reduce axial symptoms and inflammation in patients with active axPsA.

“What I say is, there is a rationale for [anti–IL-23] to work in psoriatic arthritis, and not work in ankylosing spondylitis,” she said.

In contrast, IL-17 inhibitors, anti-TNF agents, and Janus kinase inhibitors show efficacy against both axPsA and AS. Rituximab is ineffective against PsA, but has shown efficacy against AS, especially in patients with neurologic complications from anti-TNF agents.

“There may be other medications that would work more specifically in axial psoriatic arthritis that don’t work in ankylosing spondylitis, but at least recognizing that there may be some differences, and that therefore a correct diagnosis should be obtained, might be important,” she said.

Ideally, the picture will become clearer with results from the ongoing Axial Involvement in Psoriatic Arthritis cohort, a joint project of ASAS and the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis. The multinational, cross-sectional study is designed “to systematically evaluate clinical and imaging manifestations indicative of axial involvement in patients with PsA and to develop classification criteria and a unified nomenclature for axial involvement in PsA that would allow defining a homogeneous subgroup of patients for research.”

Stay tuned.

Dr. Gladman’s research is supported by a grant from the Krembil Foundation. Dr. Singh disclosed research support from various companies. Funding sources and conflict of interest disclosures from other works cited are contained in their respective references.

The Food and Drug Administration has expanded the indication of dapagliflozin (Farxiga, AstraZeneca) to include treatment of heart failure across the full spectrum of left ventricular ejection fraction (LVEF) – including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).

The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).

The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.

In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.

In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.

The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.

The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.

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

The Food and Drug Administration has expanded the indication of dapagliflozin (Farxiga, AstraZeneca) to include treatment of heart failure across the full spectrum of left ventricular ejection fraction (LVEF) – including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).

The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).

The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.

In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.

In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.

The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.

The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.

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

The Food and Drug Administration has expanded the indication of dapagliflozin (Farxiga, AstraZeneca) to include treatment of heart failure across the full spectrum of left ventricular ejection fraction (LVEF) – including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).

The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).

The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.

In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.

In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.

The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.

The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.

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

Try practicing inpatient medicine without nurses.

You can’t.

In a world where doctors get top billing, nurses are the unsung heroes that really make it all happen. We blow in and out of the rooms, write notes, check results and vitals, then move on to the next person.

But the nurses are the ones who actually make this all happen. And, amazingly, can do all that work with a smile.

But in our current postpandemic world, we’re facing a serious shortage. A recent survey of registered nurses found that only 15% of hospital nurses were planning on being there in 1 year. Thirty percent said they were planning on changing careers entirely in the aftermath of the pandemic. Their job satisfaction scores have dropped 15% from 2019 to 2023. Their stress scores, and concerns that the job is affecting their health, have increased 15%-20%.

The problem reflects a combination of things intersecting at a bad time: Staffing shortages resulting in more patients per nurse, hospital administrators cutting corners on staffing and pay, and the ongoing state of incivility.

The last one is a particularly new issue. Difficult patients and their families are nothing new. We all encounter them, and learn to deal with them in our own way. It’s part of the territory.

But since 2020 it’s climbed to a new-level of in-your-face confrontation, rudeness, and aggression, sometimes leading to violence. Physical attacks on people in all jobs have increased, but health care workers are five times more likely to encounter workplace violence than any other field.

Underpaid, overworked, and a sitting duck for violence. Can you blame people for looking elsewhere?

All of this is coming at a time when a whole generation of nurses is retiring, another generation is starting to reach an age of needing more health care, and nursing schools are short on teaching staff, limiting the number of new people that can be trained. Nursing education, like medical school, isn’t a place to cut corners (neither is care, obviously).

These days we toss the word “burnout” around to the point that it’s become almost meaningless, but to those affected by it, the consequences are quite real. And when it causes a loss of staff and impairs the ability of all to provide quality medical care, it quickly becomes everyone’s problem.

Finding solutions for such things isn’t a can you just kick down the road, as governmental agencies have always been so good at doing. These are things that have real-world consequences for all involved, and solutions need to involve private, public, and educational sectors working together.

I don’t have any ideas, but I hope the people who can change this will sit down and work some out.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Try practicing inpatient medicine without nurses.

You can’t.

In a world where doctors get top billing, nurses are the unsung heroes that really make it all happen. We blow in and out of the rooms, write notes, check results and vitals, then move on to the next person.

But the nurses are the ones who actually make this all happen. And, amazingly, can do all that work with a smile.

But in our current postpandemic world, we’re facing a serious shortage. A recent survey of registered nurses found that only 15% of hospital nurses were planning on being there in 1 year. Thirty percent said they were planning on changing careers entirely in the aftermath of the pandemic. Their job satisfaction scores have dropped 15% from 2019 to 2023. Their stress scores, and concerns that the job is affecting their health, have increased 15%-20%.

The problem reflects a combination of things intersecting at a bad time: Staffing shortages resulting in more patients per nurse, hospital administrators cutting corners on staffing and pay, and the ongoing state of incivility.

The last one is a particularly new issue. Difficult patients and their families are nothing new. We all encounter them, and learn to deal with them in our own way. It’s part of the territory.

But since 2020 it’s climbed to a new-level of in-your-face confrontation, rudeness, and aggression, sometimes leading to violence. Physical attacks on people in all jobs have increased, but health care workers are five times more likely to encounter workplace violence than any other field.

Underpaid, overworked, and a sitting duck for violence. Can you blame people for looking elsewhere?

All of this is coming at a time when a whole generation of nurses is retiring, another generation is starting to reach an age of needing more health care, and nursing schools are short on teaching staff, limiting the number of new people that can be trained. Nursing education, like medical school, isn’t a place to cut corners (neither is care, obviously).

These days we toss the word “burnout” around to the point that it’s become almost meaningless, but to those affected by it, the consequences are quite real. And when it causes a loss of staff and impairs the ability of all to provide quality medical care, it quickly becomes everyone’s problem.

Finding solutions for such things isn’t a can you just kick down the road, as governmental agencies have always been so good at doing. These are things that have real-world consequences for all involved, and solutions need to involve private, public, and educational sectors working together.

I don’t have any ideas, but I hope the people who can change this will sit down and work some out.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Try practicing inpatient medicine without nurses.

You can’t.

In a world where doctors get top billing, nurses are the unsung heroes that really make it all happen. We blow in and out of the rooms, write notes, check results and vitals, then move on to the next person.

But the nurses are the ones who actually make this all happen. And, amazingly, can do all that work with a smile.

But in our current postpandemic world, we’re facing a serious shortage. A recent survey of registered nurses found that only 15% of hospital nurses were planning on being there in 1 year. Thirty percent said they were planning on changing careers entirely in the aftermath of the pandemic. Their job satisfaction scores have dropped 15% from 2019 to 2023. Their stress scores, and concerns that the job is affecting their health, have increased 15%-20%.

The problem reflects a combination of things intersecting at a bad time: Staffing shortages resulting in more patients per nurse, hospital administrators cutting corners on staffing and pay, and the ongoing state of incivility.

The last one is a particularly new issue. Difficult patients and their families are nothing new. We all encounter them, and learn to deal with them in our own way. It’s part of the territory.

But since 2020 it’s climbed to a new-level of in-your-face confrontation, rudeness, and aggression, sometimes leading to violence. Physical attacks on people in all jobs have increased, but health care workers are five times more likely to encounter workplace violence than any other field.

Underpaid, overworked, and a sitting duck for violence. Can you blame people for looking elsewhere?

All of this is coming at a time when a whole generation of nurses is retiring, another generation is starting to reach an age of needing more health care, and nursing schools are short on teaching staff, limiting the number of new people that can be trained. Nursing education, like medical school, isn’t a place to cut corners (neither is care, obviously).

These days we toss the word “burnout” around to the point that it’s become almost meaningless, but to those affected by it, the consequences are quite real. And when it causes a loss of staff and impairs the ability of all to provide quality medical care, it quickly becomes everyone’s problem.

Finding solutions for such things isn’t a can you just kick down the road, as governmental agencies have always been so good at doing. These are things that have real-world consequences for all involved, and solutions need to involve private, public, and educational sectors working together.

I don’t have any ideas, but I hope the people who can change this will sit down and work some out.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

CHICAGO – It’s been 125 years since the founding of the American Gastroenterological Association (AGA). It’s gone from a small organization in which gastroenterology wasn’t even a known medical specialty, to an organization that grants millions of dollars in research funding each year.

University of California San Diego

Congratulating the organization on its 125th anniversary, AGA president John M. Carethers, MD, AGAF, reflected on its history and outlined many accomplishments and challenges. He spoke with optimism about gastroenterology’s future during his presidential address on May 8 at the annual Digestive Disease Week® (DDW) meeting in Chicago.

“I congratulate the AGA on its quasquicentennial, or 125th anniversary,” said Dr. Carethers, who is distinguished professor of medicine and vice chancellor for health sciences at the University of California, San Diego.

The AGA was founded in 1897 by Detroit-based physician Charles Aaron, MD. His passion was gastroenterology, but at that point, it wasn’t an established medical discipline. Dr. Aaron, Max Einhorn, MD, and 8 other colleagues formed the American Gastroenterological Association. Today, with nearly 16,000 members, the organization has become a driving force in improving the care of patients with gastrointestinal conditions.

Among AGA’s accomplishments since its founding: In 1940, the American Board of Internal Medicine certified gastroenterology as a subspecialty. Three years later, the first issue of Gastroenterology, the AGA’s flagship journal, was published. And, in 1971, the very first Digestive Disease Week® meeting took place.

In terms of medical advances that have been made since those early years, the list is vast: From the description of ileitis in 1932 by Burril B. Crohn, MD, in 1932 to the discovery of the hepatitis B surface antigen in 1965 and the more recent discovery of germline mutations in DNA mismatch repair genes as a cause of Lynch syndrome.

Dr. Carethers outlined goals for the future, including building a leadership team that is “reflective of our practice here in the United States,” Dr. Carethers said. Creating a culturally and gender diverse leadership team will only strengthen the organization and the practice of gastroenterology. The AGA’s first female president, Sarah Jordan, MD, was named in 1942, and since then, the AGA has been led by women and men from different ethnic backgrounds, including himself, who is AGA’s first president of African American heritage.

The AGA has committed to a number of diversity and equity objectives, including the AGA Equity Project, an initiative launched in 2020 whose goal is to achieve equity and eradicate disparities in digestive diseases with a focus on justice and equity, research and funding, workforce and leadership, recognition of the achievements of people of color, unconscious bias, and engagement with early career members.

“I am not only excited about the diversity and equity objectives within our specialty ... but also the innovation and things to come for our specialty,” Dr. Carethers said.

Securing funding for early-stage innovations in medicine can be difficult across medical disciplines, including gastroenterology. So, last year, the AGA, with Varia Ventures, launched the GI Opportunity Fund 1 to support early-stage GI-based companies. The goal is to raise $25 million for the initial fund. Through the AGA’s Center for GI Innovation and Technology and the AGA Tech Summit, early-stage companies may have new funding opportunities.

And, through the AGA Research Foundation, the organization will continue to support clinical research. Last year, $2.6 million in grants were awarded to investigators.

Dr. Carethers is a board director at Avantor, a life sciences supply company.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

CHICAGO – It’s been 125 years since the founding of the American Gastroenterological Association (AGA). It’s gone from a small organization in which gastroenterology wasn’t even a known medical specialty, to an organization that grants millions of dollars in research funding each year.

University of California San Diego

Congratulating the organization on its 125th anniversary, AGA president John M. Carethers, MD, AGAF, reflected on its history and outlined many accomplishments and challenges. He spoke with optimism about gastroenterology’s future during his presidential address on May 8 at the annual Digestive Disease Week® (DDW) meeting in Chicago.

“I congratulate the AGA on its quasquicentennial, or 125th anniversary,” said Dr. Carethers, who is distinguished professor of medicine and vice chancellor for health sciences at the University of California, San Diego.

The AGA was founded in 1897 by Detroit-based physician Charles Aaron, MD. His passion was gastroenterology, but at that point, it wasn’t an established medical discipline. Dr. Aaron, Max Einhorn, MD, and 8 other colleagues formed the American Gastroenterological Association. Today, with nearly 16,000 members, the organization has become a driving force in improving the care of patients with gastrointestinal conditions.

Among AGA’s accomplishments since its founding: In 1940, the American Board of Internal Medicine certified gastroenterology as a subspecialty. Three years later, the first issue of Gastroenterology, the AGA’s flagship journal, was published. And, in 1971, the very first Digestive Disease Week® meeting took place.

In terms of medical advances that have been made since those early years, the list is vast: From the description of ileitis in 1932 by Burril B. Crohn, MD, in 1932 to the discovery of the hepatitis B surface antigen in 1965 and the more recent discovery of germline mutations in DNA mismatch repair genes as a cause of Lynch syndrome.

Dr. Carethers outlined goals for the future, including building a leadership team that is “reflective of our practice here in the United States,” Dr. Carethers said. Creating a culturally and gender diverse leadership team will only strengthen the organization and the practice of gastroenterology. The AGA’s first female president, Sarah Jordan, MD, was named in 1942, and since then, the AGA has been led by women and men from different ethnic backgrounds, including himself, who is AGA’s first president of African American heritage.

The AGA has committed to a number of diversity and equity objectives, including the AGA Equity Project, an initiative launched in 2020 whose goal is to achieve equity and eradicate disparities in digestive diseases with a focus on justice and equity, research and funding, workforce and leadership, recognition of the achievements of people of color, unconscious bias, and engagement with early career members.

“I am not only excited about the diversity and equity objectives within our specialty ... but also the innovation and things to come for our specialty,” Dr. Carethers said.

Securing funding for early-stage innovations in medicine can be difficult across medical disciplines, including gastroenterology. So, last year, the AGA, with Varia Ventures, launched the GI Opportunity Fund 1 to support early-stage GI-based companies. The goal is to raise $25 million for the initial fund. Through the AGA’s Center for GI Innovation and Technology and the AGA Tech Summit, early-stage companies may have new funding opportunities.

And, through the AGA Research Foundation, the organization will continue to support clinical research. Last year, $2.6 million in grants were awarded to investigators.

Dr. Carethers is a board director at Avantor, a life sciences supply company.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

CHICAGO – It’s been 125 years since the founding of the American Gastroenterological Association (AGA). It’s gone from a small organization in which gastroenterology wasn’t even a known medical specialty, to an organization that grants millions of dollars in research funding each year.

University of California San Diego

Congratulating the organization on its 125th anniversary, AGA president John M. Carethers, MD, AGAF, reflected on its history and outlined many accomplishments and challenges. He spoke with optimism about gastroenterology’s future during his presidential address on May 8 at the annual Digestive Disease Week® (DDW) meeting in Chicago.

“I congratulate the AGA on its quasquicentennial, or 125th anniversary,” said Dr. Carethers, who is distinguished professor of medicine and vice chancellor for health sciences at the University of California, San Diego.

The AGA was founded in 1897 by Detroit-based physician Charles Aaron, MD. His passion was gastroenterology, but at that point, it wasn’t an established medical discipline. Dr. Aaron, Max Einhorn, MD, and 8 other colleagues formed the American Gastroenterological Association. Today, with nearly 16,000 members, the organization has become a driving force in improving the care of patients with gastrointestinal conditions.

Among AGA’s accomplishments since its founding: In 1940, the American Board of Internal Medicine certified gastroenterology as a subspecialty. Three years later, the first issue of Gastroenterology, the AGA’s flagship journal, was published. And, in 1971, the very first Digestive Disease Week® meeting took place.

In terms of medical advances that have been made since those early years, the list is vast: From the description of ileitis in 1932 by Burril B. Crohn, MD, in 1932 to the discovery of the hepatitis B surface antigen in 1965 and the more recent discovery of germline mutations in DNA mismatch repair genes as a cause of Lynch syndrome.

Dr. Carethers outlined goals for the future, including building a leadership team that is “reflective of our practice here in the United States,” Dr. Carethers said. Creating a culturally and gender diverse leadership team will only strengthen the organization and the practice of gastroenterology. The AGA’s first female president, Sarah Jordan, MD, was named in 1942, and since then, the AGA has been led by women and men from different ethnic backgrounds, including himself, who is AGA’s first president of African American heritage.

The AGA has committed to a number of diversity and equity objectives, including the AGA Equity Project, an initiative launched in 2020 whose goal is to achieve equity and eradicate disparities in digestive diseases with a focus on justice and equity, research and funding, workforce and leadership, recognition of the achievements of people of color, unconscious bias, and engagement with early career members.

“I am not only excited about the diversity and equity objectives within our specialty ... but also the innovation and things to come for our specialty,” Dr. Carethers said.

Securing funding for early-stage innovations in medicine can be difficult across medical disciplines, including gastroenterology. So, last year, the AGA, with Varia Ventures, launched the GI Opportunity Fund 1 to support early-stage GI-based companies. The goal is to raise $25 million for the initial fund. Through the AGA’s Center for GI Innovation and Technology and the AGA Tech Summit, early-stage companies may have new funding opportunities.

And, through the AGA Research Foundation, the organization will continue to support clinical research. Last year, $2.6 million in grants were awarded to investigators.

Dr. Carethers is a board director at Avantor, a life sciences supply company.

The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

Diffuse Lung Disease and Lung Transplant Network

Lung Transplant Section

In March 2023, the Composite Allocation Score (CAS) will replace the Lung Allocation Score (LAS) for matching donor lungs to transplant candidates in the United States. The LAS was implemented in 2005 to improve lung organ utilization. Its score was determined by two main factors: (1) risk of 1-year waitlist mortality and (2) likelihood of 1-year post-transplant survival, with the first factor having twice the weight. However, LAS did not account for candidate biology attributes, such as pediatric age, blood type, allosensitization, or height. Long-term survival outcomes under LAS may be reduced, given the greater emphasis on waitlist mortality. Candidates were also subjected to strict geographical distributions within a 250-nautical-mile radius, which frequently resulted in those with lower LAS obtaining a transplant. CAS differs from the LAS in that it assigns an allocation score in a continuous distribution based on the following factors: medical urgency, expected survival benefit following transplant, pediatric age, blood type, HLA antibody sensitization, candidate height, and geographical proximity to the donor organ. Each factor has a specific weight, and because donor factors contribute to CAS, a candidate’s score changes with each donor-recipient match run. Continuous distribution removes hard geographical boundaries and aims for more equitable organ allocation. To understand how allocation might change with CAS, Valapour and colleagues created various CAS scenarios using data from individuals on the national transplant waiting list (Am J Transplant. 2022;22[12]:2971).

They found that waitlist deaths decreased by 36%-47%. This effect was greatest in scenarios where there was less weight on placement efficiency (ie, geography) and more weight on post-transplant outcomes. Transplant system equity also improved in their simulation models. It will be exciting to see how candidate and recipient outcomes are affected once CAS is implemented.

Gloria Li, MD
Member-at-Large

Keith Wille, MD, MSPH
Member-at-Large

Reference

1. United Network for Organ Sharing. www.unos.org.

Diffuse Lung Disease and Lung Transplant Network

Lung Transplant Section

In March 2023, the Composite Allocation Score (CAS) will replace the Lung Allocation Score (LAS) for matching donor lungs to transplant candidates in the United States. The LAS was implemented in 2005 to improve lung organ utilization. Its score was determined by two main factors: (1) risk of 1-year waitlist mortality and (2) likelihood of 1-year post-transplant survival, with the first factor having twice the weight. However, LAS did not account for candidate biology attributes, such as pediatric age, blood type, allosensitization, or height. Long-term survival outcomes under LAS may be reduced, given the greater emphasis on waitlist mortality. Candidates were also subjected to strict geographical distributions within a 250-nautical-mile radius, which frequently resulted in those with lower LAS obtaining a transplant. CAS differs from the LAS in that it assigns an allocation score in a continuous distribution based on the following factors: medical urgency, expected survival benefit following transplant, pediatric age, blood type, HLA antibody sensitization, candidate height, and geographical proximity to the donor organ. Each factor has a specific weight, and because donor factors contribute to CAS, a candidate’s score changes with each donor-recipient match run. Continuous distribution removes hard geographical boundaries and aims for more equitable organ allocation. To understand how allocation might change with CAS, Valapour and colleagues created various CAS scenarios using data from individuals on the national transplant waiting list (Am J Transplant. 2022;22[12]:2971).

They found that waitlist deaths decreased by 36%-47%. This effect was greatest in scenarios where there was less weight on placement efficiency (ie, geography) and more weight on post-transplant outcomes. Transplant system equity also improved in their simulation models. It will be exciting to see how candidate and recipient outcomes are affected once CAS is implemented.

Gloria Li, MD
Member-at-Large

Keith Wille, MD, MSPH
Member-at-Large

Reference

1. United Network for Organ Sharing. www.unos.org.

Diffuse Lung Disease and Lung Transplant Network

Lung Transplant Section

In March 2023, the Composite Allocation Score (CAS) will replace the Lung Allocation Score (LAS) for matching donor lungs to transplant candidates in the United States. The LAS was implemented in 2005 to improve lung organ utilization. Its score was determined by two main factors: (1) risk of 1-year waitlist mortality and (2) likelihood of 1-year post-transplant survival, with the first factor having twice the weight. However, LAS did not account for candidate biology attributes, such as pediatric age, blood type, allosensitization, or height. Long-term survival outcomes under LAS may be reduced, given the greater emphasis on waitlist mortality. Candidates were also subjected to strict geographical distributions within a 250-nautical-mile radius, which frequently resulted in those with lower LAS obtaining a transplant. CAS differs from the LAS in that it assigns an allocation score in a continuous distribution based on the following factors: medical urgency, expected survival benefit following transplant, pediatric age, blood type, HLA antibody sensitization, candidate height, and geographical proximity to the donor organ. Each factor has a specific weight, and because donor factors contribute to CAS, a candidate’s score changes with each donor-recipient match run. Continuous distribution removes hard geographical boundaries and aims for more equitable organ allocation. To understand how allocation might change with CAS, Valapour and colleagues created various CAS scenarios using data from individuals on the national transplant waiting list (Am J Transplant. 2022;22[12]:2971).

They found that waitlist deaths decreased by 36%-47%. This effect was greatest in scenarios where there was less weight on placement efficiency (ie, geography) and more weight on post-transplant outcomes. Transplant system equity also improved in their simulation models. It will be exciting to see how candidate and recipient outcomes are affected once CAS is implemented.

Gloria Li, MD
Member-at-Large

Keith Wille, MD, MSPH
Member-at-Large

Reference

1. United Network for Organ Sharing. www.unos.org.

Critical Care Network

Sepsis/Shock Section

Sepsis remains the commonest diagnosis for hospital stays in the United States and the top hospital readmission diagnosis, with aggregate costs of $23.7 billion in 2013 (https://datatools.ahrq.gov/hcup-fast-stats; Kim H, et al. Front Public Health. 2022;10:882715; Torio C, Moore B. 2016. HCUP Statistical Brief #204).

Since 2013, the Hospital Readmissions Reduction Program (HRRP) adopted pneumonia as a readmission measure, and in 2016, this measure included sepsis patients with pneumonia and aspiration pneumonia. For 2023, the Centers for Medicare and Medicaid Services (CMS) suppressed pneumonia as a readmission measure due to COVID-19’s significant impact (www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program). Though sepsis is not a direct readmission measure, it could be one in the future. Studies found higher long-term mortality for patients with sepsis readmitted for recurrent sepsis (Pandolfi F, et al. Crit Care. 2022;26[1]:371; McNamara JF, et al. Int J Infect Dis. 2022;114:34).

A systematic review showed independent risk factors predictive of sepsis readmission: older age, male gender, African American and Asian ethnicities, higher baseline comorbidities, and discharge to a facility. In contrast, sepsis-specific risk factors were extended-spectrum beta-lactamase gram-negative bacterial infections, increased hospital length of stay during initial admission, and increased illness severity (Shankar-Hari M, et al. Intensive Care Med. 2020;46[4]:619; Amrollahi F, et al. J Am Med Inform Assoc. 2022;29[7]:1263; Gadre SK, et al. Chest. 2019;155[3]:483).

McNamara and colleagues found that patients with gram-negative bloodstream infections had higher readmission rates for sepsis during a 4-year follow-up and had a lower 5-year survival rates Int J Infect Dis. 2022;114:34). Hospitals can prevent readmissions by strengthening antimicrobial stewardship programs to ensure appropriate and adequate treatment of initial infections. Other predictive risk factors for readmission are lower socioeconomic status (Shankar-Hari M, et al. Intensive Care Med. 2020;46[4]:619), lack of health insurance, and delays seeking medical care due to lack of transportation (Amrollahi F, et al. J Am Med Inform Assoc. 2022;29[7]:1263).

Sepsis readmissions can be mitigated by predictive analytics, better access to health care, establishing post-discharge clinic follow-ups, transportation arrangements, and telemedicine. More research is needed to evaluate sepsis readmission prevention.

Shu Xian Lee, MD

Fellow-in-Training

Deepa Gotur, MD, FCCP

Member-at-Large

Critical Care Network

Sepsis/Shock Section

Sepsis remains the commonest diagnosis for hospital stays in the United States and the top hospital readmission diagnosis, with aggregate costs of $23.7 billion in 2013 (https://datatools.ahrq.gov/hcup-fast-stats; Kim H, et al. Front Public Health. 2022;10:882715; Torio C, Moore B. 2016. HCUP Statistical Brief #204).

Since 2013, the Hospital Readmissions Reduction Program (HRRP) adopted pneumonia as a readmission measure, and in 2016, this measure included sepsis patients with pneumonia and aspiration pneumonia. For 2023, the Centers for Medicare and Medicaid Services (CMS) suppressed pneumonia as a readmission measure due to COVID-19’s significant impact (www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program). Though sepsis is not a direct readmission measure, it could be one in the future. Studies found higher long-term mortality for patients with sepsis readmitted for recurrent sepsis (Pandolfi F, et al. Crit Care. 2022;26[1]:371; McNamara JF, et al. Int J Infect Dis. 2022;114:34).

A systematic review showed independent risk factors predictive of sepsis readmission: older age, male gender, African American and Asian ethnicities, higher baseline comorbidities, and discharge to a facility. In contrast, sepsis-specific risk factors were extended-spectrum beta-lactamase gram-negative bacterial infections, increased hospital length of stay during initial admission, and increased illness severity (Shankar-Hari M, et al. Intensive Care Med. 2020;46[4]:619; Amrollahi F, et al. J Am Med Inform Assoc. 2022;29[7]:1263; Gadre SK, et al. Chest. 2019;155[3]:483).

McNamara and colleagues found that patients with gram-negative bloodstream infections had higher readmission rates for sepsis during a 4-year follow-up and had a lower 5-year survival rates Int J Infect Dis. 2022;114:34). Hospitals can prevent readmissions by strengthening antimicrobial stewardship programs to ensure appropriate and adequate treatment of initial infections. Other predictive risk factors for readmission are lower socioeconomic status (Shankar-Hari M, et al. Intensive Care Med. 2020;46[4]:619), lack of health insurance, and delays seeking medical care due to lack of transportation (Amrollahi F, et al. J Am Med Inform Assoc. 2022;29[7]:1263).

Sepsis readmissions can be mitigated by predictive analytics, better access to health care, establishing post-discharge clinic follow-ups, transportation arrangements, and telemedicine. More research is needed to evaluate sepsis readmission prevention.

Shu Xian Lee, MD

Fellow-in-Training

Deepa Gotur, MD, FCCP

Member-at-Large

Critical Care Network

Sepsis/Shock Section

Sepsis remains the commonest diagnosis for hospital stays in the United States and the top hospital readmission diagnosis, with aggregate costs of $23.7 billion in 2013 (https://datatools.ahrq.gov/hcup-fast-stats; Kim H, et al. Front Public Health. 2022;10:882715; Torio C, Moore B. 2016. HCUP Statistical Brief #204).

Since 2013, the Hospital Readmissions Reduction Program (HRRP) adopted pneumonia as a readmission measure, and in 2016, this measure included sepsis patients with pneumonia and aspiration pneumonia. For 2023, the Centers for Medicare and Medicaid Services (CMS) suppressed pneumonia as a readmission measure due to COVID-19’s significant impact (www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program). Though sepsis is not a direct readmission measure, it could be one in the future. Studies found higher long-term mortality for patients with sepsis readmitted for recurrent sepsis (Pandolfi F, et al. Crit Care. 2022;26[1]:371; McNamara JF, et al. Int J Infect Dis. 2022;114:34).

A systematic review showed independent risk factors predictive of sepsis readmission: older age, male gender, African American and Asian ethnicities, higher baseline comorbidities, and discharge to a facility. In contrast, sepsis-specific risk factors were extended-spectrum beta-lactamase gram-negative bacterial infections, increased hospital length of stay during initial admission, and increased illness severity (Shankar-Hari M, et al. Intensive Care Med. 2020;46[4]:619; Amrollahi F, et al. J Am Med Inform Assoc. 2022;29[7]:1263; Gadre SK, et al. Chest. 2019;155[3]:483).

McNamara and colleagues found that patients with gram-negative bloodstream infections had higher readmission rates for sepsis during a 4-year follow-up and had a lower 5-year survival rates Int J Infect Dis. 2022;114:34). Hospitals can prevent readmissions by strengthening antimicrobial stewardship programs to ensure appropriate and adequate treatment of initial infections. Other predictive risk factors for readmission are lower socioeconomic status (Shankar-Hari M, et al. Intensive Care Med. 2020;46[4]:619), lack of health insurance, and delays seeking medical care due to lack of transportation (Amrollahi F, et al. J Am Med Inform Assoc. 2022;29[7]:1263).

Sepsis readmissions can be mitigated by predictive analytics, better access to health care, establishing post-discharge clinic follow-ups, transportation arrangements, and telemedicine. More research is needed to evaluate sepsis readmission prevention.

Shu Xian Lee, MD

Fellow-in-Training

Deepa Gotur, MD, FCCP

Member-at-Large

Based on discussions during PancreasFest 2021, a group of experts and key opinion leaders have proposed a new definition of exocrine pancreatic insufficiency (EPI) and best practices for diagnosis and management, according to a recent report in Gastro Hep Advances

Due to its complex and individualized nature, EPI requires multidisciplinary approaches to therapy, as well as better pancreas function tests and biomarkers for diagnosis and treatment, wrote researchers who were led by David C. Whitcomb, MD, PhD, AGAF, emeritus professor of medicine in the division of gastroenterology, hepatology and nutrition at the University of Pittsburgh.

University of Pittsburgh

“This condition remains challenging even to define, and serious limitations in diagnostic testing and therapeutic options lead to clinical confusion and frequently less than optimal patient management,” the authors wrote.

EPI is clinically defined as inadequate delivery of pancreatic digestive enzymes to meet nutritional needs, which is typically based on a physician’s assessment of a patient’s maldigestion. However, there’s not a universally accepted definition or a precise threshold of reduced pancreatic digestive enzymes that indicates “pancreatic insufficiency” in an individual patient.

Current guidelines also don’t clearly outline the role of pancreatic function tests, the effects of different metabolic needs and nutrition intake, the timing of pancreatic enzyme replacement therapy (PERT), or the best practices for monitoring or titrating multiple therapies.

In response, Dr. Whitcomb and colleagues proposed a new mechanistic definition of EPI, including the disorder’s physiologic effects and impact on health. First, they said, EPI is a disorder caused by failure of the pancreas to deliver a minimum or threshold level of specific pancreatic digestive enzymes to the intestine in concert with ingested nutrients, followed by enzymatic digestion of individual meals over time to meet certain nutritional and metabolic needs. In addition, the disorder is characterized by variable deficiencies in micronutrients and macronutrients, especially essential fats and fat-soluble vitamins, as well as gastrointestinal symptoms of nutrient maldigestion.

The threshold for EPI should consider the nutritional needs of the patient, dietary intake, residual exocrine pancreas function, and the absorptive capacity of the intestine based on anatomy, mucosal function, motility, inflammation, the microbiome, and physiological adaptation, the authors wrote.

Due to challenges in diagnosing EPI and its common chronic symptoms such as abdominal pain, bloating, and diarrhea, several conditions may mimic EPI, be present concomitantly with EPI, or hinder PERT response. These include celiac disease, small intestinal bacterial overgrowth, disaccharidase deficiencies, inflammatory bowel disease (IBD), bile acid diarrhea, giardiasis, diabetes mellitus, and functional conditions such as irritable bowel syndrome. These conditions should be considered to address underlying pathology and PERT diagnostic challenges.

Although there is consensus that exocrine pancreatic function testing (PFT) is important to diagnosis EPI, no optimal test exists, and pancreatic function is only one aspect of digestion and absorption that should be considered. PFT may be needed to make an objective EPI diagnosis related to acute pancreatitis, pancreatic cancer, pancreatic resection, gastric resection, cystic fibrosis, or IBD. Direct or indirect PFTs may be used, which typically differs by center.

“The medical community still awaits a clinically useful pancreas function test that is easy to perform, well tolerated by patients, and allows personalized dosing of PERT,” the authors wrote.

After diagnosis, a general assessment should include information about symptoms, nutritional status, medications, diet, and lifestyle. This information can be used for a multifaceted treatment approach, with a focus on lifestyle changes, concomitant disease treatment, optimized diet, dietary supplements, and PERT administration.

PERT remains a mainstay of EPI treatment and has shown improvements in steatorrhea, postprandial bloating and pain, nutrition, and unexplained weight loss. The Food and Drug Administration has approved several formulations in different strengths. The typical starting dose is based on age and weight, which is derived from guidelines for EPI treatment in patients with cystic fibrosis. However, the recommendations don’t consider many of the variables discussed above and simply provide an estimate for the average subject with severe EPI, so the dose should be titrated as needed based on age, weight, symptoms, and the holistic management plan.

For optimal results, regular follow-up is necessary to monitor compliance and treatment response. A reduction in symptoms can serve as a reliable indicator of effective EPI management, particularly weight stabilization, improved steatorrhea and diarrhea, and reduced postprandial bloating, pain, and flatulence. Physicians may provide patients with tracking tools to record their PERT compliance, symptom frequency, and lifestyle changes.

For patients with persistent concerns, PERT can be increased as needed. Although many PERT formulations are enteric coated, a proton pump inhibitor or H2 receptor agonist may improve their effectiveness. If EPI symptoms persist despite increased doses, other causes of malabsorption should be considered, such as the concomitant conditions mentioned above.

“As EPI escalates, a lower fat diet may become necessary to alleviate distressing gastrointestinal symptoms,” the authors wrote. “A close working relationship between the treating provider and the [registered dietician] is crucial so that barriers to optimum nutrient assimilation can be identified, communicated, and overcome. Frequent monitoring of the nutritional state with therapy is also imperative.”

PancreasFest 2021 received no specific funding for this event. The authors declared grant support, adviser roles, and speaking honoraria from several pharmaceutical and medical device companies and health care foundations, including the National Pancreas Foundation.

Based on discussions during PancreasFest 2021, a group of experts and key opinion leaders have proposed a new definition of exocrine pancreatic insufficiency (EPI) and best practices for diagnosis and management, according to a recent report in Gastro Hep Advances

Due to its complex and individualized nature, EPI requires multidisciplinary approaches to therapy, as well as better pancreas function tests and biomarkers for diagnosis and treatment, wrote researchers who were led by David C. Whitcomb, MD, PhD, AGAF, emeritus professor of medicine in the division of gastroenterology, hepatology and nutrition at the University of Pittsburgh.

University of Pittsburgh

“This condition remains challenging even to define, and serious limitations in diagnostic testing and therapeutic options lead to clinical confusion and frequently less than optimal patient management,” the authors wrote.

EPI is clinically defined as inadequate delivery of pancreatic digestive enzymes to meet nutritional needs, which is typically based on a physician’s assessment of a patient’s maldigestion. However, there’s not a universally accepted definition or a precise threshold of reduced pancreatic digestive enzymes that indicates “pancreatic insufficiency” in an individual patient.

Current guidelines also don’t clearly outline the role of pancreatic function tests, the effects of different metabolic needs and nutrition intake, the timing of pancreatic enzyme replacement therapy (PERT), or the best practices for monitoring or titrating multiple therapies.

In response, Dr. Whitcomb and colleagues proposed a new mechanistic definition of EPI, including the disorder’s physiologic effects and impact on health. First, they said, EPI is a disorder caused by failure of the pancreas to deliver a minimum or threshold level of specific pancreatic digestive enzymes to the intestine in concert with ingested nutrients, followed by enzymatic digestion of individual meals over time to meet certain nutritional and metabolic needs. In addition, the disorder is characterized by variable deficiencies in micronutrients and macronutrients, especially essential fats and fat-soluble vitamins, as well as gastrointestinal symptoms of nutrient maldigestion.

The threshold for EPI should consider the nutritional needs of the patient, dietary intake, residual exocrine pancreas function, and the absorptive capacity of the intestine based on anatomy, mucosal function, motility, inflammation, the microbiome, and physiological adaptation, the authors wrote.

Due to challenges in diagnosing EPI and its common chronic symptoms such as abdominal pain, bloating, and diarrhea, several conditions may mimic EPI, be present concomitantly with EPI, or hinder PERT response. These include celiac disease, small intestinal bacterial overgrowth, disaccharidase deficiencies, inflammatory bowel disease (IBD), bile acid diarrhea, giardiasis, diabetes mellitus, and functional conditions such as irritable bowel syndrome. These conditions should be considered to address underlying pathology and PERT diagnostic challenges.

Although there is consensus that exocrine pancreatic function testing (PFT) is important to diagnosis EPI, no optimal test exists, and pancreatic function is only one aspect of digestion and absorption that should be considered. PFT may be needed to make an objective EPI diagnosis related to acute pancreatitis, pancreatic cancer, pancreatic resection, gastric resection, cystic fibrosis, or IBD. Direct or indirect PFTs may be used, which typically differs by center.

“The medical community still awaits a clinically useful pancreas function test that is easy to perform, well tolerated by patients, and allows personalized dosing of PERT,” the authors wrote.

After diagnosis, a general assessment should include information about symptoms, nutritional status, medications, diet, and lifestyle. This information can be used for a multifaceted treatment approach, with a focus on lifestyle changes, concomitant disease treatment, optimized diet, dietary supplements, and PERT administration.

PERT remains a mainstay of EPI treatment and has shown improvements in steatorrhea, postprandial bloating and pain, nutrition, and unexplained weight loss. The Food and Drug Administration has approved several formulations in different strengths. The typical starting dose is based on age and weight, which is derived from guidelines for EPI treatment in patients with cystic fibrosis. However, the recommendations don’t consider many of the variables discussed above and simply provide an estimate for the average subject with severe EPI, so the dose should be titrated as needed based on age, weight, symptoms, and the holistic management plan.

For optimal results, regular follow-up is necessary to monitor compliance and treatment response. A reduction in symptoms can serve as a reliable indicator of effective EPI management, particularly weight stabilization, improved steatorrhea and diarrhea, and reduced postprandial bloating, pain, and flatulence. Physicians may provide patients with tracking tools to record their PERT compliance, symptom frequency, and lifestyle changes.

For patients with persistent concerns, PERT can be increased as needed. Although many PERT formulations are enteric coated, a proton pump inhibitor or H2 receptor agonist may improve their effectiveness. If EPI symptoms persist despite increased doses, other causes of malabsorption should be considered, such as the concomitant conditions mentioned above.

“As EPI escalates, a lower fat diet may become necessary to alleviate distressing gastrointestinal symptoms,” the authors wrote. “A close working relationship between the treating provider and the [registered dietician] is crucial so that barriers to optimum nutrient assimilation can be identified, communicated, and overcome. Frequent monitoring of the nutritional state with therapy is also imperative.”

PancreasFest 2021 received no specific funding for this event. The authors declared grant support, adviser roles, and speaking honoraria from several pharmaceutical and medical device companies and health care foundations, including the National Pancreas Foundation.

Based on discussions during PancreasFest 2021, a group of experts and key opinion leaders have proposed a new definition of exocrine pancreatic insufficiency (EPI) and best practices for diagnosis and management, according to a recent report in Gastro Hep Advances

Due to its complex and individualized nature, EPI requires multidisciplinary approaches to therapy, as well as better pancreas function tests and biomarkers for diagnosis and treatment, wrote researchers who were led by David C. Whitcomb, MD, PhD, AGAF, emeritus professor of medicine in the division of gastroenterology, hepatology and nutrition at the University of Pittsburgh.

University of Pittsburgh

“This condition remains challenging even to define, and serious limitations in diagnostic testing and therapeutic options lead to clinical confusion and frequently less than optimal patient management,” the authors wrote.

EPI is clinically defined as inadequate delivery of pancreatic digestive enzymes to meet nutritional needs, which is typically based on a physician’s assessment of a patient’s maldigestion. However, there’s not a universally accepted definition or a precise threshold of reduced pancreatic digestive enzymes that indicates “pancreatic insufficiency” in an individual patient.

Current guidelines also don’t clearly outline the role of pancreatic function tests, the effects of different metabolic needs and nutrition intake, the timing of pancreatic enzyme replacement therapy (PERT), or the best practices for monitoring or titrating multiple therapies.

In response, Dr. Whitcomb and colleagues proposed a new mechanistic definition of EPI, including the disorder’s physiologic effects and impact on health. First, they said, EPI is a disorder caused by failure of the pancreas to deliver a minimum or threshold level of specific pancreatic digestive enzymes to the intestine in concert with ingested nutrients, followed by enzymatic digestion of individual meals over time to meet certain nutritional and metabolic needs. In addition, the disorder is characterized by variable deficiencies in micronutrients and macronutrients, especially essential fats and fat-soluble vitamins, as well as gastrointestinal symptoms of nutrient maldigestion.

The threshold for EPI should consider the nutritional needs of the patient, dietary intake, residual exocrine pancreas function, and the absorptive capacity of the intestine based on anatomy, mucosal function, motility, inflammation, the microbiome, and physiological adaptation, the authors wrote.

Due to challenges in diagnosing EPI and its common chronic symptoms such as abdominal pain, bloating, and diarrhea, several conditions may mimic EPI, be present concomitantly with EPI, or hinder PERT response. These include celiac disease, small intestinal bacterial overgrowth, disaccharidase deficiencies, inflammatory bowel disease (IBD), bile acid diarrhea, giardiasis, diabetes mellitus, and functional conditions such as irritable bowel syndrome. These conditions should be considered to address underlying pathology and PERT diagnostic challenges.

Although there is consensus that exocrine pancreatic function testing (PFT) is important to diagnosis EPI, no optimal test exists, and pancreatic function is only one aspect of digestion and absorption that should be considered. PFT may be needed to make an objective EPI diagnosis related to acute pancreatitis, pancreatic cancer, pancreatic resection, gastric resection, cystic fibrosis, or IBD. Direct or indirect PFTs may be used, which typically differs by center.

“The medical community still awaits a clinically useful pancreas function test that is easy to perform, well tolerated by patients, and allows personalized dosing of PERT,” the authors wrote.

After diagnosis, a general assessment should include information about symptoms, nutritional status, medications, diet, and lifestyle. This information can be used for a multifaceted treatment approach, with a focus on lifestyle changes, concomitant disease treatment, optimized diet, dietary supplements, and PERT administration.

PERT remains a mainstay of EPI treatment and has shown improvements in steatorrhea, postprandial bloating and pain, nutrition, and unexplained weight loss. The Food and Drug Administration has approved several formulations in different strengths. The typical starting dose is based on age and weight, which is derived from guidelines for EPI treatment in patients with cystic fibrosis. However, the recommendations don’t consider many of the variables discussed above and simply provide an estimate for the average subject with severe EPI, so the dose should be titrated as needed based on age, weight, symptoms, and the holistic management plan.

For optimal results, regular follow-up is necessary to monitor compliance and treatment response. A reduction in symptoms can serve as a reliable indicator of effective EPI management, particularly weight stabilization, improved steatorrhea and diarrhea, and reduced postprandial bloating, pain, and flatulence. Physicians may provide patients with tracking tools to record their PERT compliance, symptom frequency, and lifestyle changes.

For patients with persistent concerns, PERT can be increased as needed. Although many PERT formulations are enteric coated, a proton pump inhibitor or H2 receptor agonist may improve their effectiveness. If EPI symptoms persist despite increased doses, other causes of malabsorption should be considered, such as the concomitant conditions mentioned above.

“As EPI escalates, a lower fat diet may become necessary to alleviate distressing gastrointestinal symptoms,” the authors wrote. “A close working relationship between the treating provider and the [registered dietician] is crucial so that barriers to optimum nutrient assimilation can be identified, communicated, and overcome. Frequent monitoring of the nutritional state with therapy is also imperative.”

PancreasFest 2021 received no specific funding for this event. The authors declared grant support, adviser roles, and speaking honoraria from several pharmaceutical and medical device companies and health care foundations, including the National Pancreas Foundation.

CHICAGO – The total annual waste generated by a single, large academic endoscopy unit over 2 months could cover about two football fields, according to Madhav Desai, MD, MPH, assistant professor of medicine at the University of Minnesota, Minneapolis. About 20% of the waste, most of which went to landfills, was potentially recyclable, he said in a presentation given at the annual Digestive Disease Week® meeting.

Gastrointestinal endoscopies are critical for the screening, diagnosis, and treatment of a variety of gastrointestinal conditions. But like other medical procedures, endoscopies are a source of environmental waste, including plastic, sharps, personal protective equipment (PPE), and cleaning supplies, and also energy waste.

Walter Alexander/MDedge News

“This all goes back to the damage that mankind is inflicting on the environment in general, with the health care sector as one of the top contributors to plastic waste generation, landfills and water wastage,” Dr. Desai said. “Endoscopies, with their numerous benefits, substantially increase waste generation through landfill waste and liquid consumption and waste through the cleaning of endoscopes. We have a responsibility to look into this topic.”

To prospectively assess total waste generation from their institution, Dr. Desai, who was with the Kansas City (Mo.) Veterans Administration Medical Center, when the research was conducted, collected data on the items used in 450 consecutive procedures from May to June 2022. The data included procedure type, accessory use, intravenous tubing, numbers of biopsy jars, linens, PPE, and more, beginning at the point of patient entry to the endoscopy unit until discharge. They also collected data on waste generation related to reprocessing after each procedure and daily energy use (including endoscopy equipment, lights, and computers). With an eye toward finding opportunities to improve and maximize waste recycling, they stratified waste into the three categories of biohazardous, nonbiohazardous, or potentially recyclable.

“We found that the total waste generated during the time period was 1,398.6 kg, with more than half of it, 61.6%, going directly to landfill,” Dr. Desai said in an interview. “That’s an amount that an average family in the U.S. would use for 2 months. That’s a huge amount.”
 

Most waste consists of sharps

Exactly one-third was biohazard waste and 5.1% was sharps, they found. A single procedure, on average, sent 2.19 kg of waste to landfill. Extrapolated to 1 year, the waste total amounts to 9,189 kg (equivalent to just over 10 U.S. tons) and per 100 procedures to 219 kg (about 483 pounds).

They estimated 20% of the landfill waste was potentially recyclable (such as plastic CO₂ tubing, O₂ connector, syringes, etc.), which could reduce the total landfill burden by 8.6 kg per day or 2,580 kg per year (or 61 kg per 100 procedures). Reprocessing endoscopes generated 194 gallons of liquid waste (735.26 kg) per day or 1,385 gallons per 100 procedures.

Turning to energy consumption, Dr. Desai reported that daily use in the endoscopy unit was 277.1 kW-hours (equivalent to 8.2 gallons of gasoline), adding up to about 1,980 kW per 100 procedures. “That 100-procedure amount is the equivalent of the energy used for an average fuel efficiency car to travel 1,200 miles, the distance from Seattle to San Diego,” he said.

“One next step,” Dr. Desai said, “is getting help from GI societies to come together and have endoscopy units track their own performance. You need benchmarks so that you can determine how good an endoscopist you are with respect to waste.”

He commented further:“We all owe it to the environment. And, we have all witnessed what Mother Nature can do to you.”

Working on the potentially recyclable materials that account for 20% of the total waste would be a simple initial step to reduce waste going to landfills, Dr. Desai and colleagues concluded in the meeting abstract. “These data could serve as an actionable model for health systems to reduce total waste generation and move toward environmentally sustainable endoscopy units,” they wrote.

The authors reported no disclosures.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

CHICAGO – The total annual waste generated by a single, large academic endoscopy unit over 2 months could cover about two football fields, according to Madhav Desai, MD, MPH, assistant professor of medicine at the University of Minnesota, Minneapolis. About 20% of the waste, most of which went to landfills, was potentially recyclable, he said in a presentation given at the annual Digestive Disease Week® meeting.

Gastrointestinal endoscopies are critical for the screening, diagnosis, and treatment of a variety of gastrointestinal conditions. But like other medical procedures, endoscopies are a source of environmental waste, including plastic, sharps, personal protective equipment (PPE), and cleaning supplies, and also energy waste.

Walter Alexander/MDedge News

“This all goes back to the damage that mankind is inflicting on the environment in general, with the health care sector as one of the top contributors to plastic waste generation, landfills and water wastage,” Dr. Desai said. “Endoscopies, with their numerous benefits, substantially increase waste generation through landfill waste and liquid consumption and waste through the cleaning of endoscopes. We have a responsibility to look into this topic.”

To prospectively assess total waste generation from their institution, Dr. Desai, who was with the Kansas City (Mo.) Veterans Administration Medical Center, when the research was conducted, collected data on the items used in 450 consecutive procedures from May to June 2022. The data included procedure type, accessory use, intravenous tubing, numbers of biopsy jars, linens, PPE, and more, beginning at the point of patient entry to the endoscopy unit until discharge. They also collected data on waste generation related to reprocessing after each procedure and daily energy use (including endoscopy equipment, lights, and computers). With an eye toward finding opportunities to improve and maximize waste recycling, they stratified waste into the three categories of biohazardous, nonbiohazardous, or potentially recyclable.

“We found that the total waste generated during the time period was 1,398.6 kg, with more than half of it, 61.6%, going directly to landfill,” Dr. Desai said in an interview. “That’s an amount that an average family in the U.S. would use for 2 months. That’s a huge amount.”
 

Most waste consists of sharps

Exactly one-third was biohazard waste and 5.1% was sharps, they found. A single procedure, on average, sent 2.19 kg of waste to landfill. Extrapolated to 1 year, the waste total amounts to 9,189 kg (equivalent to just over 10 U.S. tons) and per 100 procedures to 219 kg (about 483 pounds).

They estimated 20% of the landfill waste was potentially recyclable (such as plastic CO₂ tubing, O₂ connector, syringes, etc.), which could reduce the total landfill burden by 8.6 kg per day or 2,580 kg per year (or 61 kg per 100 procedures). Reprocessing endoscopes generated 194 gallons of liquid waste (735.26 kg) per day or 1,385 gallons per 100 procedures.

Turning to energy consumption, Dr. Desai reported that daily use in the endoscopy unit was 277.1 kW-hours (equivalent to 8.2 gallons of gasoline), adding up to about 1,980 kW per 100 procedures. “That 100-procedure amount is the equivalent of the energy used for an average fuel efficiency car to travel 1,200 miles, the distance from Seattle to San Diego,” he said.

“One next step,” Dr. Desai said, “is getting help from GI societies to come together and have endoscopy units track their own performance. You need benchmarks so that you can determine how good an endoscopist you are with respect to waste.”

He commented further:“We all owe it to the environment. And, we have all witnessed what Mother Nature can do to you.”

Working on the potentially recyclable materials that account for 20% of the total waste would be a simple initial step to reduce waste going to landfills, Dr. Desai and colleagues concluded in the meeting abstract. “These data could serve as an actionable model for health systems to reduce total waste generation and move toward environmentally sustainable endoscopy units,” they wrote.

The authors reported no disclosures.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.

CHICAGO – The total annual waste generated by a single, large academic endoscopy unit over 2 months could cover about two football fields, according to Madhav Desai, MD, MPH, assistant professor of medicine at the University of Minnesota, Minneapolis. About 20% of the waste, most of which went to landfills, was potentially recyclable, he said in a presentation given at the annual Digestive Disease Week® meeting.

Gastrointestinal endoscopies are critical for the screening, diagnosis, and treatment of a variety of gastrointestinal conditions. But like other medical procedures, endoscopies are a source of environmental waste, including plastic, sharps, personal protective equipment (PPE), and cleaning supplies, and also energy waste.

Walter Alexander/MDedge News

“This all goes back to the damage that mankind is inflicting on the environment in general, with the health care sector as one of the top contributors to plastic waste generation, landfills and water wastage,” Dr. Desai said. “Endoscopies, with their numerous benefits, substantially increase waste generation through landfill waste and liquid consumption and waste through the cleaning of endoscopes. We have a responsibility to look into this topic.”

To prospectively assess total waste generation from their institution, Dr. Desai, who was with the Kansas City (Mo.) Veterans Administration Medical Center, when the research was conducted, collected data on the items used in 450 consecutive procedures from May to June 2022. The data included procedure type, accessory use, intravenous tubing, numbers of biopsy jars, linens, PPE, and more, beginning at the point of patient entry to the endoscopy unit until discharge. They also collected data on waste generation related to reprocessing after each procedure and daily energy use (including endoscopy equipment, lights, and computers). With an eye toward finding opportunities to improve and maximize waste recycling, they stratified waste into the three categories of biohazardous, nonbiohazardous, or potentially recyclable.

“We found that the total waste generated during the time period was 1,398.6 kg, with more than half of it, 61.6%, going directly to landfill,” Dr. Desai said in an interview. “That’s an amount that an average family in the U.S. would use for 2 months. That’s a huge amount.”
 

Most waste consists of sharps

Exactly one-third was biohazard waste and 5.1% was sharps, they found. A single procedure, on average, sent 2.19 kg of waste to landfill. Extrapolated to 1 year, the waste total amounts to 9,189 kg (equivalent to just over 10 U.S. tons) and per 100 procedures to 219 kg (about 483 pounds).

They estimated 20% of the landfill waste was potentially recyclable (such as plastic CO₂ tubing, O₂ connector, syringes, etc.), which could reduce the total landfill burden by 8.6 kg per day or 2,580 kg per year (or 61 kg per 100 procedures). Reprocessing endoscopes generated 194 gallons of liquid waste (735.26 kg) per day or 1,385 gallons per 100 procedures.

Turning to energy consumption, Dr. Desai reported that daily use in the endoscopy unit was 277.1 kW-hours (equivalent to 8.2 gallons of gasoline), adding up to about 1,980 kW per 100 procedures. “That 100-procedure amount is the equivalent of the energy used for an average fuel efficiency car to travel 1,200 miles, the distance from Seattle to San Diego,” he said.

“One next step,” Dr. Desai said, “is getting help from GI societies to come together and have endoscopy units track their own performance. You need benchmarks so that you can determine how good an endoscopist you are with respect to waste.”

He commented further:“We all owe it to the environment. And, we have all witnessed what Mother Nature can do to you.”

Working on the potentially recyclable materials that account for 20% of the total waste would be a simple initial step to reduce waste going to landfills, Dr. Desai and colleagues concluded in the meeting abstract. “These data could serve as an actionable model for health systems to reduce total waste generation and move toward environmentally sustainable endoscopy units,” they wrote.

The authors reported no disclosures.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and The Society for Surgery of the Alimentary Tract.