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The history and findings in this case are suggestive of leukemic non-nodal mantle cell lymphoma (MCL).

MCL is a rare mature B-cell neoplasm characterized by t(11;14) (q13;q32) and cyclin D1 overexpression in more than 95% of cases. It accounts for approximately 5%-7% of all lymphomas, with an annual incidence of one case per 200,000 people. In North America and Europe, the incidence of MCL is like that of noncutaneous peripheral T-cell lymphomas. MCL occurs more frequently in men than in women (3:1), and the median age at diagnosis ranges from ages 60-70 years. 

In recent years, MCL has been categorized into two major subgroups that have distinct clinical presentation and molecular features: nodal MCL and leukemic non-nodal MCL. Nodal MCL is a common variant with an aggressive disease course. Unmutated IGHV gene rearrangement, SOX11 overexpression, a higher degree of genomic instability (eg, ATM, CDKN2A, chromatin modifier mutations), and other oncogenic mutations and epigenetic modifications are seen in patients with this variant. 

Leukemic non-nodal MCL is seen in 10%-20% of patients with MCL. Patients frequently present with lymphocytosis and splenomegaly. In most cases, it is associated with an indolent disease course and superior outcome. This subtype is largely IGHV mutated and mostly SOX11-negative, with positive expression of CD200, peripheral blood, bone marrow, and splenic involvement, low tumor burden, and a low Ki-67 index.

Recognition of the leukemic non-nodal MCL immunophenotype enables it to be differentiated from other CD5-positive B-cell cancers, particularly classical MCL and chronic lymphocytic leukemia (CLL). The overexpression of cyclin D1, the presence of the t(11;14) translocation, and the absence of chromosomal markers typically present in CLL differentiate leukemic non-nodal MCL from CLL. Moreover, CLL has high expression of CD23 and is negative for SOX11 and CD200.

Pathologic features of MCL include small- to medium-size lymphocytes with scant cytoplasm, clumped chromatin, inconspicuous nucleoli, and prominent nuclear clefts. Observed growth patterns include diffuse, nodular (more vague and less discrete than that found in follicular lymphomas), mantle-zone lymphoma with expansion of mantle zones, and in situ mantle-cell neoplasia [typical cells with the characteristic t(11;14) translocation, scattered in the mantle zone of otherwise normal-appearing lymph nodes]. Cytologic subtypes include classic MCL, the blastoid subtype (large cells, dispersed chromatin, and a high mitotic rate), and the pleomorphic subtype (cells of variable sizes, although many are large, with pale cytoplasm, oval irregular nuclei, and prominent nucleoli). 

MCL is a challenging disease to treat. Despite treatment advances, it is largely incurable, with a median overall survival of 1.8-9.4 years, depending on whether it is aggressive or indolent MCL. The aggressiveness of the disease, the patient's performance status, age, and mantle cell international prognostic index score should all be considered when selecting treatment because there is no standard curative treatment. 

According to the 2023 guidelines from the National Comprehensive Cancer Network (NCCN), for patients with indolent disease (eg, IGHV mutated and mostly SOX11-negative with leukemic and non-nodal presentation), observation is reasonable when patients are asymptomatic and have no indications for treatment. For patients with symptomatic disease or other indications for treatment, induction therapy with aggressive regimens is recommended when patients do not have a TP53 mutation. The optimum approach for patients with TP53 mutation is not yet known; induction therapy followed by high-dose therapy with autologous stem cell transplant or less aggressive regimens could be an option for these patients.

Treatment options for relapsed/refractory MCL include radiotherapy; traditional chemotherapy regimens, with or without rituximab; and newer targeted therapies. These include Bruton tyrosine kinase inhibitors (ibrutinib, zanubrutinib, acalabrutinib, pirtobrutinib), lenalidomide, bortezomib, the mammalian target of rapamycin inhibitors temsirolimus and everolimus, the phosphatidylinositol 3–kinase inhibitors idelalisib and umbralisib, and the B-cell lymphoma 2 inhibitor venetoclax. These agents are frequently administered in combination with rituximab or another anti-CD20 antibody.

For comprehensive guidance on the treatment of MCL, consult the complete NCCN guidelines.

 

Timothy J. Voorhees, MD, MSCR, Assistant Professor of Internal Medicine - Clinical, Division of Hematology, The Ohio State University James Comprehensive Cancer Center, Columbus, OH.

Timothy J. Voorhees, MD, MSCR, has disclosed the following relevant financial relationships:
Received research grant from: AstraZeneca; Morphosys; Incyte; Recordati.

 

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The history and findings in this case are suggestive of leukemic non-nodal mantle cell lymphoma (MCL).

MCL is a rare mature B-cell neoplasm characterized by t(11;14) (q13;q32) and cyclin D1 overexpression in more than 95% of cases. It accounts for approximately 5%-7% of all lymphomas, with an annual incidence of one case per 200,000 people. In North America and Europe, the incidence of MCL is like that of noncutaneous peripheral T-cell lymphomas. MCL occurs more frequently in men than in women (3:1), and the median age at diagnosis ranges from ages 60-70 years. 

In recent years, MCL has been categorized into two major subgroups that have distinct clinical presentation and molecular features: nodal MCL and leukemic non-nodal MCL. Nodal MCL is a common variant with an aggressive disease course. Unmutated IGHV gene rearrangement, SOX11 overexpression, a higher degree of genomic instability (eg, ATM, CDKN2A, chromatin modifier mutations), and other oncogenic mutations and epigenetic modifications are seen in patients with this variant. 

Leukemic non-nodal MCL is seen in 10%-20% of patients with MCL. Patients frequently present with lymphocytosis and splenomegaly. In most cases, it is associated with an indolent disease course and superior outcome. This subtype is largely IGHV mutated and mostly SOX11-negative, with positive expression of CD200, peripheral blood, bone marrow, and splenic involvement, low tumor burden, and a low Ki-67 index.

Recognition of the leukemic non-nodal MCL immunophenotype enables it to be differentiated from other CD5-positive B-cell cancers, particularly classical MCL and chronic lymphocytic leukemia (CLL). The overexpression of cyclin D1, the presence of the t(11;14) translocation, and the absence of chromosomal markers typically present in CLL differentiate leukemic non-nodal MCL from CLL. Moreover, CLL has high expression of CD23 and is negative for SOX11 and CD200.

Pathologic features of MCL include small- to medium-size lymphocytes with scant cytoplasm, clumped chromatin, inconspicuous nucleoli, and prominent nuclear clefts. Observed growth patterns include diffuse, nodular (more vague and less discrete than that found in follicular lymphomas), mantle-zone lymphoma with expansion of mantle zones, and in situ mantle-cell neoplasia [typical cells with the characteristic t(11;14) translocation, scattered in the mantle zone of otherwise normal-appearing lymph nodes]. Cytologic subtypes include classic MCL, the blastoid subtype (large cells, dispersed chromatin, and a high mitotic rate), and the pleomorphic subtype (cells of variable sizes, although many are large, with pale cytoplasm, oval irregular nuclei, and prominent nucleoli). 

MCL is a challenging disease to treat. Despite treatment advances, it is largely incurable, with a median overall survival of 1.8-9.4 years, depending on whether it is aggressive or indolent MCL. The aggressiveness of the disease, the patient's performance status, age, and mantle cell international prognostic index score should all be considered when selecting treatment because there is no standard curative treatment. 

According to the 2023 guidelines from the National Comprehensive Cancer Network (NCCN), for patients with indolent disease (eg, IGHV mutated and mostly SOX11-negative with leukemic and non-nodal presentation), observation is reasonable when patients are asymptomatic and have no indications for treatment. For patients with symptomatic disease or other indications for treatment, induction therapy with aggressive regimens is recommended when patients do not have a TP53 mutation. The optimum approach for patients with TP53 mutation is not yet known; induction therapy followed by high-dose therapy with autologous stem cell transplant or less aggressive regimens could be an option for these patients.

Treatment options for relapsed/refractory MCL include radiotherapy; traditional chemotherapy regimens, with or without rituximab; and newer targeted therapies. These include Bruton tyrosine kinase inhibitors (ibrutinib, zanubrutinib, acalabrutinib, pirtobrutinib), lenalidomide, bortezomib, the mammalian target of rapamycin inhibitors temsirolimus and everolimus, the phosphatidylinositol 3–kinase inhibitors idelalisib and umbralisib, and the B-cell lymphoma 2 inhibitor venetoclax. These agents are frequently administered in combination with rituximab or another anti-CD20 antibody.

For comprehensive guidance on the treatment of MCL, consult the complete NCCN guidelines.

 

Timothy J. Voorhees, MD, MSCR, Assistant Professor of Internal Medicine - Clinical, Division of Hematology, The Ohio State University James Comprehensive Cancer Center, Columbus, OH.

Timothy J. Voorhees, MD, MSCR, has disclosed the following relevant financial relationships:
Received research grant from: AstraZeneca; Morphosys; Incyte; Recordati.

 

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

The history and findings in this case are suggestive of leukemic non-nodal mantle cell lymphoma (MCL).

MCL is a rare mature B-cell neoplasm characterized by t(11;14) (q13;q32) and cyclin D1 overexpression in more than 95% of cases. It accounts for approximately 5%-7% of all lymphomas, with an annual incidence of one case per 200,000 people. In North America and Europe, the incidence of MCL is like that of noncutaneous peripheral T-cell lymphomas. MCL occurs more frequently in men than in women (3:1), and the median age at diagnosis ranges from ages 60-70 years. 

In recent years, MCL has been categorized into two major subgroups that have distinct clinical presentation and molecular features: nodal MCL and leukemic non-nodal MCL. Nodal MCL is a common variant with an aggressive disease course. Unmutated IGHV gene rearrangement, SOX11 overexpression, a higher degree of genomic instability (eg, ATM, CDKN2A, chromatin modifier mutations), and other oncogenic mutations and epigenetic modifications are seen in patients with this variant. 

Leukemic non-nodal MCL is seen in 10%-20% of patients with MCL. Patients frequently present with lymphocytosis and splenomegaly. In most cases, it is associated with an indolent disease course and superior outcome. This subtype is largely IGHV mutated and mostly SOX11-negative, with positive expression of CD200, peripheral blood, bone marrow, and splenic involvement, low tumor burden, and a low Ki-67 index.

Recognition of the leukemic non-nodal MCL immunophenotype enables it to be differentiated from other CD5-positive B-cell cancers, particularly classical MCL and chronic lymphocytic leukemia (CLL). The overexpression of cyclin D1, the presence of the t(11;14) translocation, and the absence of chromosomal markers typically present in CLL differentiate leukemic non-nodal MCL from CLL. Moreover, CLL has high expression of CD23 and is negative for SOX11 and CD200.

Pathologic features of MCL include small- to medium-size lymphocytes with scant cytoplasm, clumped chromatin, inconspicuous nucleoli, and prominent nuclear clefts. Observed growth patterns include diffuse, nodular (more vague and less discrete than that found in follicular lymphomas), mantle-zone lymphoma with expansion of mantle zones, and in situ mantle-cell neoplasia [typical cells with the characteristic t(11;14) translocation, scattered in the mantle zone of otherwise normal-appearing lymph nodes]. Cytologic subtypes include classic MCL, the blastoid subtype (large cells, dispersed chromatin, and a high mitotic rate), and the pleomorphic subtype (cells of variable sizes, although many are large, with pale cytoplasm, oval irregular nuclei, and prominent nucleoli). 

MCL is a challenging disease to treat. Despite treatment advances, it is largely incurable, with a median overall survival of 1.8-9.4 years, depending on whether it is aggressive or indolent MCL. The aggressiveness of the disease, the patient's performance status, age, and mantle cell international prognostic index score should all be considered when selecting treatment because there is no standard curative treatment. 

According to the 2023 guidelines from the National Comprehensive Cancer Network (NCCN), for patients with indolent disease (eg, IGHV mutated and mostly SOX11-negative with leukemic and non-nodal presentation), observation is reasonable when patients are asymptomatic and have no indications for treatment. For patients with symptomatic disease or other indications for treatment, induction therapy with aggressive regimens is recommended when patients do not have a TP53 mutation. The optimum approach for patients with TP53 mutation is not yet known; induction therapy followed by high-dose therapy with autologous stem cell transplant or less aggressive regimens could be an option for these patients.

Treatment options for relapsed/refractory MCL include radiotherapy; traditional chemotherapy regimens, with or without rituximab; and newer targeted therapies. These include Bruton tyrosine kinase inhibitors (ibrutinib, zanubrutinib, acalabrutinib, pirtobrutinib), lenalidomide, bortezomib, the mammalian target of rapamycin inhibitors temsirolimus and everolimus, the phosphatidylinositol 3–kinase inhibitors idelalisib and umbralisib, and the B-cell lymphoma 2 inhibitor venetoclax. These agents are frequently administered in combination with rituximab or another anti-CD20 antibody.

For comprehensive guidance on the treatment of MCL, consult the complete NCCN guidelines.

 

Timothy J. Voorhees, MD, MSCR, Assistant Professor of Internal Medicine - Clinical, Division of Hematology, The Ohio State University James Comprehensive Cancer Center, Columbus, OH.

Timothy J. Voorhees, MD, MSCR, has disclosed the following relevant financial relationships:
Received research grant from: AstraZeneca; Morphosys; Incyte; Recordati.

 

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A 67-year-old White man presents for his annual physical examination. The patient is a physical therapist and reports regular exercise and adherence to a healthy diet. His previous medical history is unremarkable. There is a family history of non-Hodgkin lymphoma (paternal uncle). The patient has no complaints or concerns about his health.

Physical examination reveals non-tender abdominal distention and splenomegaly. Pertinent laboratory findings include hemoglobin = 10/g/dL; red blood cell = 3.28 M/mcL; mean corpuscular volume = 54.2 fL, hematocrit = 34%; and absolute lymphocyte count = 4820/µL.

Flow cytometry showed high positivity for CD5, no expression of SOX11, low expression of CD23 and CD200, and overexpression of cyclin D1. A bone marrow biopsy is performed and show an abnormal B-lymphoid infiltrate. Fluorescence in situ hybridization analysis revealed t(11;14)(q13;q32) and mutated IGHV. A blood smear showed abnormal mononuclear cells and atypical lymphocytes.

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Upadacitinib shows promise in treatment-resistant UC and Crohn’s

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Treatment-resistant patients with active ulcerative colitis and Crohn’s disease saw high remission rates and fast response after being switched to upadacitinib, according to results from a real-world study at a Chicago treatment center.

The results suggest that upadacitinib may be an appropriate salvage treatment for patients who have failed other advanced therapies, including tofacitinib.

Dr. Scott Friedberg


For their research, published in Clinical Gastroenterology and Hepatology, Scott Friedberg, MD, and colleagues at the University of Chicago’s Inflammatory Bowel Disease Center, looked at results from 44 patients diagnosed with ulcerative colitis and 40 with Crohn’s disease, all with active luminal or perianal disease. All patients in the study had previous exposure to tumor necrosis factor inhibitors, and nearly 90% had exposure to two or more advanced therapies, including tofacitinib (n = 17), before being switched to upadacitinib.

Upadacitinib (Rinvoq, AbbVie) is the second small-molecule Janus kinase (JAK) inhibitor approved for ulcerative colitis by the Food and Drug Administration in March 2022 after tofacitinib (Xeljanz, Pfizer) in 2018. Upadacitinib received an additional indication in May 2023 as a treatment for Crohn’s disease. It selectively inhibits JAK1, while tofacitinib inhibits JAK1 and JAK3.

Among the ulcerative colitis patients in Dr. Friedberg and colleagues’ study (mean age, 39 years; 48% female), 85% had a clinical response and 82% achieved clinical remission by week 8. Of nine patients previously treated with tofacitinib, seven (78%) achieved remission at 8 weeks.

Some 76% of the Crohn’s disease patients in the study (mean age, 37 years; 53% female) saw clinical response by 8 weeks, and 71% achieved remission by that time. More than 60% of all participants who had increased fecal calprotectin and C-reactive protein levels at baseline saw normalization of these biomarkers by week 8.

Some patients saw an especially fast response, with 36% of the ulcerative colitis patients and 56% of the Crohn’s patients experiencing clinical remission by week 2.

Acne was the most common reported adverse event, occurring in 23% of patients. Only one serious adverse event, an anemia requiring hospitalization, occurred during the study.

No wash-out period occurred before starting patients on upadacitinib. There were no adverse events seen associated with this strategy, Dr. Friedberg and colleagues noted, a finding with important implications for real-world practice.

“When patients with active IBD are sick, starting a new therapy as soon as it is available is not only reasonable, it is required,” the investigators wrote. Additionally, the findings support the use of upadacitinib in ulcerative colitis patients with previous exposure to tofacitinib, as “selectivity of JAK targets may have different effectiveness profiles.”

Upadacitinib’s rapid onset “has multiple advantages,” the investigators wrote, “not only by being an option for severely active disease but also by allowing for a rapid taper or complete avoidance of corticosteroids.”

The authors noted their study’s small sample size as a key limitation. Several of Dr. Friedberg’s coauthors disclosed financial relationships with drug manufacturers, including AbbVie.

Body

Understanding the efficacy, onset of action and safety of newly approved inflammatory bowel disease (IBD) therapies is difficult in the absence of real-world data as clinical trial populations are much more restrictive and typically do not reflect the patient populations seen in most IBD clinics. This single-center study by Friedberg and colleagues reports on their experience with upadacitinib use in patients with ulcerative colitis (UC) and Crohn’s disease (CD). One key finding of this study is the rapid onset of action with high rates of clinical response and remission within 2 weeks of initiation (60% and 36%) for UC and (50% and 56%) for CD. Further, these high rates of clinical response and remission were noted despite exposure to multiple prior therapies (including prior tofacitinib use), which has been a limitation with other IBD therapies.

Dr. Jill K.J. Gaidos

With the concerns for safety of tofacitinib use, another Janus kinase inhibitor, raised by the ORAL surveillance study, many patients and practitioners are concerned about the safety of upadacitinib use. This study highlighted the low rate of adverse events including no incidences of herpes zoster infection, venous thromboembolism or major adverse cardiovascular events. Acne was noted to be the most common adverse event, occurring in 22% of the study population.

Further research is needed to assess the long term clinical and endoscopic response rates as well as long-term safety assessments, however these results will facilitate conversations with patients who could potentially benefit from treatment with this new therapy.

Jill K. J. Gaidos, MD, FACG, AGAF, is associate professor of medicine, vice chief of clinical research, section of digestive diseases, Yale University, and director of clinical research, Yale Inflammatory Bowel Disease Program, New Haven, Conn.

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Understanding the efficacy, onset of action and safety of newly approved inflammatory bowel disease (IBD) therapies is difficult in the absence of real-world data as clinical trial populations are much more restrictive and typically do not reflect the patient populations seen in most IBD clinics. This single-center study by Friedberg and colleagues reports on their experience with upadacitinib use in patients with ulcerative colitis (UC) and Crohn’s disease (CD). One key finding of this study is the rapid onset of action with high rates of clinical response and remission within 2 weeks of initiation (60% and 36%) for UC and (50% and 56%) for CD. Further, these high rates of clinical response and remission were noted despite exposure to multiple prior therapies (including prior tofacitinib use), which has been a limitation with other IBD therapies.

Dr. Jill K.J. Gaidos

With the concerns for safety of tofacitinib use, another Janus kinase inhibitor, raised by the ORAL surveillance study, many patients and practitioners are concerned about the safety of upadacitinib use. This study highlighted the low rate of adverse events including no incidences of herpes zoster infection, venous thromboembolism or major adverse cardiovascular events. Acne was noted to be the most common adverse event, occurring in 22% of the study population.

Further research is needed to assess the long term clinical and endoscopic response rates as well as long-term safety assessments, however these results will facilitate conversations with patients who could potentially benefit from treatment with this new therapy.

Jill K. J. Gaidos, MD, FACG, AGAF, is associate professor of medicine, vice chief of clinical research, section of digestive diseases, Yale University, and director of clinical research, Yale Inflammatory Bowel Disease Program, New Haven, Conn.

Body

Understanding the efficacy, onset of action and safety of newly approved inflammatory bowel disease (IBD) therapies is difficult in the absence of real-world data as clinical trial populations are much more restrictive and typically do not reflect the patient populations seen in most IBD clinics. This single-center study by Friedberg and colleagues reports on their experience with upadacitinib use in patients with ulcerative colitis (UC) and Crohn’s disease (CD). One key finding of this study is the rapid onset of action with high rates of clinical response and remission within 2 weeks of initiation (60% and 36%) for UC and (50% and 56%) for CD. Further, these high rates of clinical response and remission were noted despite exposure to multiple prior therapies (including prior tofacitinib use), which has been a limitation with other IBD therapies.

Dr. Jill K.J. Gaidos

With the concerns for safety of tofacitinib use, another Janus kinase inhibitor, raised by the ORAL surveillance study, many patients and practitioners are concerned about the safety of upadacitinib use. This study highlighted the low rate of adverse events including no incidences of herpes zoster infection, venous thromboembolism or major adverse cardiovascular events. Acne was noted to be the most common adverse event, occurring in 22% of the study population.

Further research is needed to assess the long term clinical and endoscopic response rates as well as long-term safety assessments, however these results will facilitate conversations with patients who could potentially benefit from treatment with this new therapy.

Jill K. J. Gaidos, MD, FACG, AGAF, is associate professor of medicine, vice chief of clinical research, section of digestive diseases, Yale University, and director of clinical research, Yale Inflammatory Bowel Disease Program, New Haven, Conn.

Treatment-resistant patients with active ulcerative colitis and Crohn’s disease saw high remission rates and fast response after being switched to upadacitinib, according to results from a real-world study at a Chicago treatment center.

The results suggest that upadacitinib may be an appropriate salvage treatment for patients who have failed other advanced therapies, including tofacitinib.

Dr. Scott Friedberg


For their research, published in Clinical Gastroenterology and Hepatology, Scott Friedberg, MD, and colleagues at the University of Chicago’s Inflammatory Bowel Disease Center, looked at results from 44 patients diagnosed with ulcerative colitis and 40 with Crohn’s disease, all with active luminal or perianal disease. All patients in the study had previous exposure to tumor necrosis factor inhibitors, and nearly 90% had exposure to two or more advanced therapies, including tofacitinib (n = 17), before being switched to upadacitinib.

Upadacitinib (Rinvoq, AbbVie) is the second small-molecule Janus kinase (JAK) inhibitor approved for ulcerative colitis by the Food and Drug Administration in March 2022 after tofacitinib (Xeljanz, Pfizer) in 2018. Upadacitinib received an additional indication in May 2023 as a treatment for Crohn’s disease. It selectively inhibits JAK1, while tofacitinib inhibits JAK1 and JAK3.

Among the ulcerative colitis patients in Dr. Friedberg and colleagues’ study (mean age, 39 years; 48% female), 85% had a clinical response and 82% achieved clinical remission by week 8. Of nine patients previously treated with tofacitinib, seven (78%) achieved remission at 8 weeks.

Some 76% of the Crohn’s disease patients in the study (mean age, 37 years; 53% female) saw clinical response by 8 weeks, and 71% achieved remission by that time. More than 60% of all participants who had increased fecal calprotectin and C-reactive protein levels at baseline saw normalization of these biomarkers by week 8.

Some patients saw an especially fast response, with 36% of the ulcerative colitis patients and 56% of the Crohn’s patients experiencing clinical remission by week 2.

Acne was the most common reported adverse event, occurring in 23% of patients. Only one serious adverse event, an anemia requiring hospitalization, occurred during the study.

No wash-out period occurred before starting patients on upadacitinib. There were no adverse events seen associated with this strategy, Dr. Friedberg and colleagues noted, a finding with important implications for real-world practice.

“When patients with active IBD are sick, starting a new therapy as soon as it is available is not only reasonable, it is required,” the investigators wrote. Additionally, the findings support the use of upadacitinib in ulcerative colitis patients with previous exposure to tofacitinib, as “selectivity of JAK targets may have different effectiveness profiles.”

Upadacitinib’s rapid onset “has multiple advantages,” the investigators wrote, “not only by being an option for severely active disease but also by allowing for a rapid taper or complete avoidance of corticosteroids.”

The authors noted their study’s small sample size as a key limitation. Several of Dr. Friedberg’s coauthors disclosed financial relationships with drug manufacturers, including AbbVie.

Treatment-resistant patients with active ulcerative colitis and Crohn’s disease saw high remission rates and fast response after being switched to upadacitinib, according to results from a real-world study at a Chicago treatment center.

The results suggest that upadacitinib may be an appropriate salvage treatment for patients who have failed other advanced therapies, including tofacitinib.

Dr. Scott Friedberg


For their research, published in Clinical Gastroenterology and Hepatology, Scott Friedberg, MD, and colleagues at the University of Chicago’s Inflammatory Bowel Disease Center, looked at results from 44 patients diagnosed with ulcerative colitis and 40 with Crohn’s disease, all with active luminal or perianal disease. All patients in the study had previous exposure to tumor necrosis factor inhibitors, and nearly 90% had exposure to two or more advanced therapies, including tofacitinib (n = 17), before being switched to upadacitinib.

Upadacitinib (Rinvoq, AbbVie) is the second small-molecule Janus kinase (JAK) inhibitor approved for ulcerative colitis by the Food and Drug Administration in March 2022 after tofacitinib (Xeljanz, Pfizer) in 2018. Upadacitinib received an additional indication in May 2023 as a treatment for Crohn’s disease. It selectively inhibits JAK1, while tofacitinib inhibits JAK1 and JAK3.

Among the ulcerative colitis patients in Dr. Friedberg and colleagues’ study (mean age, 39 years; 48% female), 85% had a clinical response and 82% achieved clinical remission by week 8. Of nine patients previously treated with tofacitinib, seven (78%) achieved remission at 8 weeks.

Some 76% of the Crohn’s disease patients in the study (mean age, 37 years; 53% female) saw clinical response by 8 weeks, and 71% achieved remission by that time. More than 60% of all participants who had increased fecal calprotectin and C-reactive protein levels at baseline saw normalization of these biomarkers by week 8.

Some patients saw an especially fast response, with 36% of the ulcerative colitis patients and 56% of the Crohn’s patients experiencing clinical remission by week 2.

Acne was the most common reported adverse event, occurring in 23% of patients. Only one serious adverse event, an anemia requiring hospitalization, occurred during the study.

No wash-out period occurred before starting patients on upadacitinib. There were no adverse events seen associated with this strategy, Dr. Friedberg and colleagues noted, a finding with important implications for real-world practice.

“When patients with active IBD are sick, starting a new therapy as soon as it is available is not only reasonable, it is required,” the investigators wrote. Additionally, the findings support the use of upadacitinib in ulcerative colitis patients with previous exposure to tofacitinib, as “selectivity of JAK targets may have different effectiveness profiles.”

Upadacitinib’s rapid onset “has multiple advantages,” the investigators wrote, “not only by being an option for severely active disease but also by allowing for a rapid taper or complete avoidance of corticosteroids.”

The authors noted their study’s small sample size as a key limitation. Several of Dr. Friedberg’s coauthors disclosed financial relationships with drug manufacturers, including AbbVie.

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News & Perspectives from Ob.Gyn. News

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Mon, 06/19/2023 - 16:50

 

NEWS FROM THE FDA/CDC

New USPSTF draft suggests mammography start at 40, not 50

The US 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.
 

FDA approves OTC naloxone, but will cost be a barrier?

The US Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on US shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022—to $373.7 million—blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

CONFERENCE COVERAGE

Should you prescribe bioidentical hormones for menopause?

The off-label prescribing of compounded, bioidentical hormone therapy—in pills, creams, or pellets—for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the Food and Drug Administration.

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center in Amarillo.

Following the 2002 Women’s Health Initiative report showing a link between hormone therapy (HT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Dr. Kauffman said. The association was later determined to be spurious: HT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HT still is largely ignored by younger physicians, Dr. Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.
 

Once-daily nifedipine sufficient for hypertension in pregnancy

A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose—the most common adjustment—and 20.7% needed both an increase in nifedipine and an additional medication. ●

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NEWS FROM THE FDA/CDC

New USPSTF draft suggests mammography start at 40, not 50

The US 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.
 

FDA approves OTC naloxone, but will cost be a barrier?

The US Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on US shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022—to $373.7 million—blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

CONFERENCE COVERAGE

Should you prescribe bioidentical hormones for menopause?

The off-label prescribing of compounded, bioidentical hormone therapy—in pills, creams, or pellets—for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the Food and Drug Administration.

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center in Amarillo.

Following the 2002 Women’s Health Initiative report showing a link between hormone therapy (HT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Dr. Kauffman said. The association was later determined to be spurious: HT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HT still is largely ignored by younger physicians, Dr. Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.
 

Once-daily nifedipine sufficient for hypertension in pregnancy

A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose—the most common adjustment—and 20.7% needed both an increase in nifedipine and an additional medication. ●

 

NEWS FROM THE FDA/CDC

New USPSTF draft suggests mammography start at 40, not 50

The US 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.
 

FDA approves OTC naloxone, but will cost be a barrier?

The US Food and Drug Administration has approved over-the-counter sales of the overdose reversal agent Narcan (naloxone, Emergent BioSolutions). Greater access to the drug should mean more lives saved. However, it’s unclear how much the nasal spray will cost and whether pharmacies will stock the product openly on shelves.

Currently, major pharmacy chains such as CVS and Walgreens make naloxone available without prescription, but consumers have to ask a pharmacist to dispense the drug.

“The major question is what is it going to cost,” Brian Hurley, MD, MBA, president-elect of the American Society of Addiction Medicine, said in an interview. “In order for people to access it they have to be able to afford it.”

“We won’t accomplish much if people can’t afford to buy Narcan,” said Chuck Ingoglia, president and CEO of the National Council for Mental Wellbeing, in a statement. Still, he applauded the FDA.

“No single approach will end overdose deaths but making Narcan easy to obtain and widely available likely will save countless lives annually,” he said.

“The timeline for availability and price of this OTC product is determined by the manufacturer,” the FDA said in a statement.

Commissioner Robert M. Califf, MD, called for the drug’s manufacturer to “make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

Emergent BioSolutions did not comment on cost. It said in a statement that the spray “will be available on US shelves and at online retailers by the late summer,” after it has adapted Narcan for direct-to-consumer use, including more consumer-oriented packaging.

Naloxone’s cost varies, depending on geographic location and whether it is generic. According to GoodRX, a box containing two doses of generic naloxone costs $31-$100, depending on location and coupon availability.

A two-dose box of Narcan costs $135-$140. Emergent reported a 14% decline in naloxone sales in 2022—to $373.7 million—blaming it in part on the introduction of generic formulations.

Dr. Hurley said he expects those who purchase Narcan at a drug store will primarily already be shopping there. It may or may not be those who most often experience overdose, such as people leaving incarceration or experiencing homelessness.

Having Narcan available over-the-counter “is an important supplement but it doesn’t replace the existing array of naloxone distribution programs,” Dr. Hurley said.

CONFERENCE COVERAGE

Should you prescribe bioidentical hormones for menopause?

The off-label prescribing of compounded, bioidentical hormone therapy—in pills, creams, or pellets—for symptoms of perimenopause or menopause can put physicians at legal risk because the products lack scientific backing, according to an expert at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).

Clinicians write an estimated 26 to 33 million prescriptions for compounded bioidentical hormone therapy (cBHT) every year, and almost 41% of menopausal women who need treatment try cBHT during their lives. But these drugs lack the approval for this indication from the Food and Drug Administration.

“There is a public perception that this is natural, safer, and anti-aging,” said Robert Kauffman, MD, a professor of obstetrics and gynecology and assistant dean for research at Texas Tech University Health Sciences Center in Amarillo.

Following the 2002 Women’s Health Initiative report showing a link between hormone therapy (HT) and an increase in the incidence of breast cancer, medical schools have slowed or paused instructing trainees on the traditional treatment, Dr. Kauffman said. The association was later determined to be spurious: HT is not associated with a risk for all-cause mortality or deaths from cardiovascular disease or cancer. However, HT still is largely ignored by younger physicians, Dr. Kauffman said, because of unsubstantiated “dangers” such as heart attack, stroke, and deep vein thrombosis.
 

Once-daily nifedipine sufficient for hypertension in pregnancy

A single 60-mg daily dose of nifedipine appeared similarly effective as taking a 30-mg dose twice daily for treating hypertensive disorders in pregnancy, according to research presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.

The findings suggest that starting patients on a once-daily 60-mg dose is therefore reasonable, Isabelle Band, BA, a medical student at the Icahn School of Medicine at Mount Sinai, New York, told attendees. Ms. Band said in an interview that there does not appear to be a consensus on the standard of care for nifedipine dosing regimen in this population but that previous in vitro studies have shown increased metabolism of nifedipine in a physiologic state that mimics pregnancy.

“I’ve spoken to some colleagues here who say that they frequently have this debate of which dosing regimen to go with,” Ms. Band said. “I was pleasantly surprised that there was no significant difference between the two dosing regimens because once-daily dosing is less burdensome for patients and will likely improve compliance and convenience for patients.” An additional benefit of once-daily dosing relates to payers because anecdotal reports suggest insurance companies do not tend to approve twice-daily dosing as readily as once-daily dosing, Ms. Band added.

Ms. Band and her colleagues conducted a retrospective chart review of all patients with hypertensive disorders of pregnancy who were admitted to the Mount Sinai Health System between Jan. 1, 2015, and April 30, 2021, and were prescribed nifedipine in a once-daily (60-mg) or twice-daily (two 30-mg) dose. They excluded patients with renal disease and those already taking hypertensives prior to admission.

Among 237 patients who met the criteria, 59% received 60 mg in a twice-daily 30-mg dose, and 41% received 60 mg in a once-daily dose. Among patients requiring an up titration, two-thirds (67%) needed an increase in the nifedipine dose—the most common adjustment—and 20.7% needed both an increase in nifedipine and an additional medication. ●

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10 ways in which ObGyn care can be more environmentally sustainable

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Mon, 06/19/2023 - 16:53

 

Climate change has been called the biggest health threat of the 21st century.1 The health care sector is a huge contributor to global carbon emissions, accounting for almost double the emissions of global aviation. While other industries and countries are implementing mitigation measures to decrease their emissions, health care is currently on track to double its carbon emissions by 2050, even though it should be carbon neutral by that time to comply with the Paris Climate Agreement.2 There have been some national efforts to curb health care emissions, including the creation of the Office of Climate Change and Health Equity in 2021 and the passage of the Inflation Reduction Act in 2022.3 These are top-down, administrative approaches, and to be successful we will also need clinicians to understand and address this problem.

The negative impacts of heat, air pollution, and exposure to toxic substances on human health have been well documented in multiple regions across multiple specialties.4-7 The United States makes up 27% of the global health care carbon footprint—more emissions than the entire United Kingdom as a country—despite having only 4% of the world’s population.2 Culture and incentives for an overabundance of single-use supplies, not evidence for patient safety, have led to this uniquely American problem. It is evident that our health care industry is an excellent place to implement mitigation measures for carbon emissions that contribute to climate change and can improve health outcomes.

In this article, we recommend 10 practices that can decrease our carbon footprint in ObGyn. We focus on the classic motto of “Reduce, Reuse, Recycle,” while adding “Remove” and “Reimagine” to classify the ways in which we can reduce emissions while not compromising our care to patients.

Reduce

1. Minimize opened materials and single-use devices in the OR and labor and delivery

Health care is a unique setting where a culture of infection prevention and efficiency has led low-cost, single-use supplies to dominate over reusable items. While single-use items can have inexpensive purchasing costs compared to reusable items, the environmental costs required for the production and disposal of the former are often much greater. In operating rooms (ORs) and labor and delivery (LD) units, single-use items are omnipresent. Over the past decade, researchers and clinicians have started to take a closer look at these items and their carbon footprint. One group evaluated hysterectomy through a waste audit and found that the vast majority of waste from all of the cases was Spunbond Meltblown Spunbond, or SMS; plastic materialthat comprises gowns; blue wraps; and drapes; followed by hard plastic material that comprises trays and packaging.8 Moreover, production and manufacturing processes contributed to 95% of the environmental impacts of these items.8

In an effort to be time efficient, OR staff will open sterile surgical packs and individual peel-pack items prior to surgery to minimize having to find items during surgery. However, this creates an inordinate amount of waste. One group of neurosurgeons who evaluated their opened but unused supplies found that 85% of their unused items were individually opened items, leading to a waste of $2.9 million per year.9 Minor procedures like dilation and curettage, cystoscopy, and hysteroscopy do not need such a large sterile field, as these procedures are also safe to perform in the office. Hand surgeons have been quick to lead in this space, particularly with minor procedures such as carpal tunnel release. One division was able to eliminate 2.8 tons of waste and save $13,000 in a 2-year period by reducing the sterile field.10 ObGyns can work with OR and LD staff to create custom packs that minimize unused or underutilized items, helping to reduce both the carbon footprint and health care spending.

Bottom line: ObGyns can help foster a culture of having supplies available but not opened until needed during a case.

 

 

Continue to: 2. Decrease regulated medical waste...

 

 

2. Decrease regulated medical waste

Health care is unique from other fields in that there are multiple waste streams to consider. Infectious waste and items saturated in blood or capable of causing infection must be placed into regulated medical waste (RMW), or more commonly, red biohazard bags. RMW is autoclaved or incinerated prior to disposal in a landfill. This process is more financially and environmentally costly than general municipal waste (GMW). This process also requires more transport—1 study revealed that GMW traveled 20 km to a landfill for disposal, compared with the 50 km that RMW traveled for sterilized-prior-to-landfill disposal.11

Unfortunately, the vast majority of items placed in RMW are incorrectly triaged and should instead be disposed in GMW.12,13 One study performed in an emergency department revealed that 85% of waste was incorrectly placed in the RMW.12

Bottom line: ObGyns can avoid placing items in RMW that may not qualify and advocate for institution policy changes to remove RMW from places such as waiting rooms, at the patient bedside, or next to scrub sinks.

3. Reduce energy use

ORs and LD units use a lot of energy, and numerous studies have demonstrated that the heating, ventilation, and air conditioning (HVAC) system plays a large role in emissions.8,11 This can easily be fixed by “HVAC setbacks” and powering down rooms when not in use. One institution powered down ORs when not in use and reduced 234 metric tons of CO2 emissions and saved $33,000 per year.14 Transitioning to light-emitting diode (LED) lights reduced energy usage at 1 institution by almost 50%.15 Finally, computers in clinical offices, examination rooms, and administrative offices can be powered down at the end of the day. One study found that in 1 radiology department, 29 computers left on overnight and on weekends emitted 17.7 tons of CO2 emissions in 1 year.16

Bottom line: We as ObGyns can advocate for how energy can be saved outside of surgical cases, including powering down ORs and LD units, transitioning to LED lighting, and powering down workstations.

Reuse

4. Choose reusable equipment

In ObGyn practice, the most commonly used tool is the speculum. Given its omnipresence, the speculum is a great place to start to decrease our carbon footprint. Two studies have evaluated the environmental impact of reusable versus single-use disposable specula, and both demonstrated that the stainless-steel versions have less global warming potential than the acrylic varieties.17,18 Donahue and colleagues17 demonstrated that it only took 2 to 3 pelvic examinations for the cost of stainless-steel specula to break even, even when sterilized in a half-filled autoclave tray. Rodriquez, et al18 revealed that, compared with an acrylic model, the stainless-steel specula had fewer negative impacts in terms of global warming, acidification, respiratory effects, smog, and fossil fuel depletion.18

Bottom line: Strongly consider using stainless-steel specula to reduce costs and carbon emissions.

 

 

In addition to specula, ObGyns can choose reusable equipment in the OR. For example, surgeons can use stainless-steel trocars instead of disposable trocars.19 In vaginal cases, Breisky-Navratil retractors can be used instead of disposable self-retaining retractors. Plastic basins that often are included in sterile supply packs can be replaced with stainless-steel basins, which could have profound positive effects on the carbon footprint of gynecologic surgery.8 One study of ObGyns demonstrated that 95% of physicians supported waste-reduction efforts, and 66% supported utilizing reusable surgical tools instead of disposable tools.20

Bottom line: As surgeons, ObGyns have influence over what they want to use in the OR, and they can petition for reusable options over disposable options.

5. Launder the sterile blue towels

Sterile blue towels, which are made of cotton, have the largest environmental footprint compared with other disposable materials, such as plastics, and contribute greatly to toxicity in human health.8,11 Although these towels cannot be laundered and sterilized again for use in a sterile surgical field, they can be laundered and repurposed, including by environmental services to clean hospital rooms. Blue towels should be able to be laundered no matter how saturated in body fluids they are.

Bottom line: ObGyns should strive to always launder the blue towels and educate trainees and other staff in the OR to do the same.

Recycle

6. Recycle and reprocess materials and devices

While recycling is immensely important, it requires a large amount of energy to break down a material to its raw components for manufacturing. It likely reduces our carbon footprint from OR procedures by only 5%.8 However, recycling is still a good way to divert appropriate materials from landfill, saving costs and emissions at the end of a material’s life. One example is sterile blue wrap, which is a petroleum product with a recycling number of 6 and a filtration rating of N99. Blue wrap can be recycled into plastic pellets, or it can be recreated into other hospital supplies, such as gowns.

Bottom line: ObGyns can petition their hospitals to work with suppliers and waste-processing companies who have recycling programs built into their supply chains.

By contrast, reprocessing can have a much larger impact on carbon emissions. Complex items, such as advanced energy devices that can be reprocessed, result in a greater reduction in carbon emissions due to the reuse of their complex materials and manufacturing when compared with such devices that cannot be reprocessed. Recycling and reprocessing programs are already in place for several devices (TABLE). Authors of a systematic review showed that there is no evidence to support the use of single-use supplies and instruments over reprocessed items when considering instrument function, ease of use, patient safety, transmission of infection, or long-term patient outcomes.21

Bottom line: ObGyns can choose to use reprocessed items in ORs instead of single-use devices and educate staff on the safety of these items.

Continue to: Remove...

 

 

Remove

7. Remove desflurane and other volatile gases from formularies

Volatile anesthetic gases, such as desflurane, isoflurane, and nitrous oxide, are themselves potent greenhouse gases, comprising a large portion of the carbon emissions that come from the OR.22 Desflurane was developed to have a rapid onset for induction and quick recovery; however, studies have shown no clinical benefit over other gases.23 Furthermore, the costs and greenhouse gas potential are substantial. Desflurane costs 2 to 3 times more and has more than 20 times the global warming potential of the other volatile gases (FIGURE).8 Using 1 hour of desflurane is equivalent to driving 378 miles in a gas-powered vehicle, while the use of isoflurane and sevoflurane create equivalents of only 15 and 8 miles, respectively.23

Nitrous oxide is another powerful greenhouse gas that is a direct ozone depletor and can stay in the atmosphere for 114 years.22 Nitrous oxide has limited clinical use in hospitals, but it is often stored in central hospital piping. Most of the impact of nitrous oxide comes through leaks in a poor system design rather than patient delivery. One estimate reveals that more than 13 million liters of nitrous oxide are lost annually from leaks in European hospitals.22 The American Society of Anesthesiologists recommends decommissioning central piping of nitrous oxide in favor of cylinders at the point of care.24

Literature on enhanced recovery after surgery in gynecology promotes the use of propofol over volatile gases for our patients because of the high rate of postoperative nausea and vomiting seen with gases.25 Volatile gases should be a last-choice anesthetic for our patients.

Bottom line: It is critical that ObGyns work with colleagues in anesthesia to develop climate- and patient-friendly protocols for procedures.

 

 

8. Remove endocrine-disrupting chemicals from clinical supplies

Endocrine-disrupting chemicals (EDCs) are a type of chemical that alter the hormonal systems of humans, which can result in adverse health effects. Multiple studies and reviews have tied EDCs to reproductive abnormalities, such as the effects of bisphenol A (BPA) on estradiol levels, antral follicle counts, oocyte quality, and implantation rates; phthalates on fibroid burden; triclosan on embryo quality; parabens on live birth rates; and perfluoroalkylsubstances (PFAS or “forever substances”) on hypertensive disorders of pregnancy.5,26,27

What might be most shocking is that these EDCs are incorporated into medical supplies and pharmaceuticals. For example, BPA is known to line dialysis and ointment tubes, parabens are used for their antimicrobial properties in ultrasound gel and hep-locks, and phthalates are found in up to 40% of medical-use plastics and controlled-release medications. Authors of an observational study found that 74% of patients admitted to an LD unit were exposed to EDCs. In a neonatal intensive care unit (NICU), most of the supplies contained an EDC, and urinary BPA levels were elevated in neonates admitted to a NICU, raising concerns about long-term health risks.5

Bottom line: Physicians and health care institutions have an obligation to petition industry partners and suppliers to remove EDCs from their supply chains.

Reimagine

9. Educate

The field of health care sustainability remains in its infancy, but from 2007 to 2019, publications on climate change and health in academia increased by a factor of 8.29 Additionally, through waste audits, quality-improvement projects, and life cycle analyses (analytical tools to evaluate product or process emissions from materials extraction to disposal), we have gained insight into the scope of the problem, with evidence showing that our practices are largely derived from culture. It is time to provide formal education on health care sustainability to medical trainees, staff, and clinicians alike, who desire to see this topic reflected in their formal curricula.30 Start talking about it!

Bottom line: Commentaries, webinars, formal didactics sessions, in-services, and hospital workgroups to introduce this topic are a good way to teach others about the carbon footprint of our care and solutions to minimize it.

10. Engage in advocacy

Physicians have an ethical duty to advocate for change at the local, regional, and national levels if we want to see a better future for our patients, their children, and even ourselves. We should reimagine this work as an important public health initiative.31 Surveys of physicians, including ObGyns, reveal a concern about the sustainability of health care and a commitment to addressing this issue.20 ObGyns are on the frontlines of delivering care every day, so we are poised to implement changes that can impact our patients, especially when we can lead and petition hospital or local committees.20,28,32 There is much to be done, but every voice counts and can make impactful changes at every level. ●

References
  1. Costello A, Abbas M, Allen et al. Managing the health effects of climate change: Lancet and University College London Institute for Global Health Commission. Lancet. 2009;373:1693-1733.
  2. Health care climate footprint report. Health Care Without Harm website. https://www.noharm.org/ClimateFootprintReport. Accessed May 12, 2023.
  3. Balbus JM, McCannon CJ, Mataka A, et al. After COP26—putting health and equity at the center of the climate movement. N Engl J Med. 2022;386:1295-1297.
  4. Bekkar B, Pacheco S, Basu R, et al. Association of air pollution and heat exposure with preterm birth, low birth weight, and stillbirth in the US: a systematic review. JAMA Netw Open. 2020;3:e208243.
  5. Genco M, Anderson-Shaw L, Sargis RM. Unwitting accomplices: endocrine disruptors confounding clinical care. J Clin Endocrinol Metab. 2020;105:e3822-e3827.
  6. Al-Kindi SG, Sarode A, Zullo M, et al. Ambient air pollution and mortality after cardiac transplantation. J Am Coll Cardiol. 2019;74:30263035.
  7. Ghosh R, Gauderman WJ, Minor H, et al. Air pollution, weight loss and metabolic benefits of bariatric surgery: a potential model for study of metabolic effects of environmental exposures. Pediatr Obes. 2018;13:312-320.
  8. Thiel CL, Eckelman M, Guido R, et al. Environmental impacts of surgical procedures: life cycle assessment of hysterectomy in the United States. Environ Sci Technol. 2015;49:1779-1786.
  9. Zygourakis CC, Yoon S, Valencia V, et al. Operating room waste: disposable supply utilization in neurosurgical procedures. J Neurosurg. 2017;126:620-625.
  10. van Demark RE, Smith VJS, Fiegen A. Lean and green hand surgery. J Hand Surg. 2018;43:179-181.
  11. Campion N, Thiel CL, DeBlois J, et al. Life cycle assessment perspectives on delivering an infant in the US. Sci Total Environ. 2012;425:191198.
  12. Hsu S, Thiel CL, Mello MJ, Slutzman JE. Dumpster diving in the emergency department. West J Emerg Med. 2020;21:1211-1217.
  13. Mcgain F, Story D, Hendel S. An audit of intensive care unit recyclable waste. Anaesthesia. 2009;64:1299-1302.
  14. Wormer BA, Augenstein VA, Carpenter CL, et al. The green operating room: simple changes to reduce cost and our carbon footprint. Am Surg. 2013;79:666-671.
  15. Kagoma Y, Stall N, Rubinstein E, et al. People, planet and profits: the case for greening operating rooms. Can Med Assoc J. 2012;184:19051911.
  16. McCarthy CJ, Gerstenmaier JF, O’ Neill AC, et al. “EcoRadiology”— pulling the plug on wasted energy in the radiology department. Acad Radiol. 2014;21:1563-1566.
  17. Donahue LM, Hilton S, Bell SG, et al. A comparative carbon footprint analysis of disposable and reusable vaginal specula. Am J Obstet  Gynecol. 2020;223:225.e1-225.e7.
  18. Rodriguez Morris MI, Hicks A. Life cycle assessment of stainless-steel reusable speculums versus disposable acrylic speculums in a university clinic setting: a case study. Environ Res Commun. 2022;4:025002.
  19. MacNeill AJ, Lillywhite R, Brown CJ. The impact of surgery on global climate: a carbon footprinting study of operating theatres in three health systems. Lancet Planet Health. 2017;1:e381-e388.
  20. Thiel C, Duncan P, Woods N. Attitude of US obstetricians and gynaecologists to global warming and medical waste. J Health Serv Res Policy. 2017;22:162-167.
  21. Siu J, Hill AG, MacCormick AD. Systematic review of reusable versus disposable laparoscopic instruments: costs and safety. ANZ J Surg. 2017;87:28-33.
  22. Ryan SM, Nielsen CJ. Global warming potential of inhaled anesthetics: application to clinical use. Anesth Analg. 2010;111:92-98.
  23. Meyer MJ. Desflurane should des-appear: global and financial rationale. Anesth Analg. 2020;131:1317-1322.
  24. Rollins MD, Arendt KW, Carvalho B, et al. ASA Committee on Obstetric Anesthesia Working Group. Nitrous oxide. American Society of Anesthesiologists website. Accessed May 12, 2023. https://www .asahq.org/about-asa/governance-and-committees/asa-committees /committee-on-obstetric-anesthesia/nitrous-oxide.
  25. Kalogera E, Dowdy SC. Enhanced recovery pathway in gynecologic surgery: improving outcomes through evidence-based medicine. Obstet Gynecol Clin North Am. 2016;43:551-573.
  26. Zota AR, Geller RJ, Calafat AM, et al. Phthalates exposure and uterine fibroid burden among women undergoing surgical treatment for fibroids: a preliminary study. Fertil Steril. 2019;111:112-121.
  27.  Bommartio PA, Ferguson KK, Meeker JD, et al. Maternal levels of perfluoroalkyl substances (PFAS) during early pregnancy in relation to preeclampsia subtypes and biomarkers of preeclampsia risk. Environ Health Perspect. 2021;129:107004.
  28. Azouz S, Boyll P, Swanson M, et al. Managing barriers to recycling in the operating room. Am J Surg. 2019;217:634-638.
  29. Watts N, Amann M, Arnell N, et al. The 2020 report of The Lancet Countdown on health and climate change: responding to converging crises. Lancet. 2021;397:129-170.
  30. Ryan EC, Dubrow R, Sherman JD. Medical, nursing, and physician assistant student knowledge and attitudes toward climate change, pollution, and resource conservation in health care. BMC Med Educ. 2020;20:200.
  31. Giudice LC, Llamas-Clark EF, DeNicola Net al; FIGO Committee on Climate Change and Toxic Environmental Exposures. Climate change, women’s health, and the role of obstetricians and gynecologists in leadership. Int J Gynaecol Obstet. 2021;155:345-356.
  32. Yates EF, Bowder AN, Roa L, et al. Empowering surgeons, anesthesiologists, and obstetricians to incorporate environmental sustainability in the operating room. Ann Surg. 2021;273:1108-1114. 
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Kelly N. Wright, MD

Director, Division of Minimally Invasive Gynecologic Surgery
Department of Obstetrics and Gynecology
Cedars-Sinai Medical Center
Los Angeles, California

Alexandra I. Melnyk, MD, MEd

Fellow, Division of Urogynecology and Pelvic Reconstructive Surgery
Department of Obstetrics, Gynecology, and Reproductive Sciences
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania

 

The authors report no financial relationships relevant to this article. 

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Kelly N. Wright, MD

Director, Division of Minimally Invasive Gynecologic Surgery
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Cedars-Sinai Medical Center
Los Angeles, California

Alexandra I. Melnyk, MD, MEd

Fellow, Division of Urogynecology and Pelvic Reconstructive Surgery
Department of Obstetrics, Gynecology, and Reproductive Sciences
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania

 

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Director, Division of Minimally Invasive Gynecologic Surgery
Department of Obstetrics and Gynecology
Cedars-Sinai Medical Center
Los Angeles, California

Alexandra I. Melnyk, MD, MEd

Fellow, Division of Urogynecology and Pelvic Reconstructive Surgery
Department of Obstetrics, Gynecology, and Reproductive Sciences
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania

 

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Climate change has been called the biggest health threat of the 21st century.1 The health care sector is a huge contributor to global carbon emissions, accounting for almost double the emissions of global aviation. While other industries and countries are implementing mitigation measures to decrease their emissions, health care is currently on track to double its carbon emissions by 2050, even though it should be carbon neutral by that time to comply with the Paris Climate Agreement.2 There have been some national efforts to curb health care emissions, including the creation of the Office of Climate Change and Health Equity in 2021 and the passage of the Inflation Reduction Act in 2022.3 These are top-down, administrative approaches, and to be successful we will also need clinicians to understand and address this problem.

The negative impacts of heat, air pollution, and exposure to toxic substances on human health have been well documented in multiple regions across multiple specialties.4-7 The United States makes up 27% of the global health care carbon footprint—more emissions than the entire United Kingdom as a country—despite having only 4% of the world’s population.2 Culture and incentives for an overabundance of single-use supplies, not evidence for patient safety, have led to this uniquely American problem. It is evident that our health care industry is an excellent place to implement mitigation measures for carbon emissions that contribute to climate change and can improve health outcomes.

In this article, we recommend 10 practices that can decrease our carbon footprint in ObGyn. We focus on the classic motto of “Reduce, Reuse, Recycle,” while adding “Remove” and “Reimagine” to classify the ways in which we can reduce emissions while not compromising our care to patients.

Reduce

1. Minimize opened materials and single-use devices in the OR and labor and delivery

Health care is a unique setting where a culture of infection prevention and efficiency has led low-cost, single-use supplies to dominate over reusable items. While single-use items can have inexpensive purchasing costs compared to reusable items, the environmental costs required for the production and disposal of the former are often much greater. In operating rooms (ORs) and labor and delivery (LD) units, single-use items are omnipresent. Over the past decade, researchers and clinicians have started to take a closer look at these items and their carbon footprint. One group evaluated hysterectomy through a waste audit and found that the vast majority of waste from all of the cases was Spunbond Meltblown Spunbond, or SMS; plastic materialthat comprises gowns; blue wraps; and drapes; followed by hard plastic material that comprises trays and packaging.8 Moreover, production and manufacturing processes contributed to 95% of the environmental impacts of these items.8

In an effort to be time efficient, OR staff will open sterile surgical packs and individual peel-pack items prior to surgery to minimize having to find items during surgery. However, this creates an inordinate amount of waste. One group of neurosurgeons who evaluated their opened but unused supplies found that 85% of their unused items were individually opened items, leading to a waste of $2.9 million per year.9 Minor procedures like dilation and curettage, cystoscopy, and hysteroscopy do not need such a large sterile field, as these procedures are also safe to perform in the office. Hand surgeons have been quick to lead in this space, particularly with minor procedures such as carpal tunnel release. One division was able to eliminate 2.8 tons of waste and save $13,000 in a 2-year period by reducing the sterile field.10 ObGyns can work with OR and LD staff to create custom packs that minimize unused or underutilized items, helping to reduce both the carbon footprint and health care spending.

Bottom line: ObGyns can help foster a culture of having supplies available but not opened until needed during a case.

 

 

Continue to: 2. Decrease regulated medical waste...

 

 

2. Decrease regulated medical waste

Health care is unique from other fields in that there are multiple waste streams to consider. Infectious waste and items saturated in blood or capable of causing infection must be placed into regulated medical waste (RMW), or more commonly, red biohazard bags. RMW is autoclaved or incinerated prior to disposal in a landfill. This process is more financially and environmentally costly than general municipal waste (GMW). This process also requires more transport—1 study revealed that GMW traveled 20 km to a landfill for disposal, compared with the 50 km that RMW traveled for sterilized-prior-to-landfill disposal.11

Unfortunately, the vast majority of items placed in RMW are incorrectly triaged and should instead be disposed in GMW.12,13 One study performed in an emergency department revealed that 85% of waste was incorrectly placed in the RMW.12

Bottom line: ObGyns can avoid placing items in RMW that may not qualify and advocate for institution policy changes to remove RMW from places such as waiting rooms, at the patient bedside, or next to scrub sinks.

3. Reduce energy use

ORs and LD units use a lot of energy, and numerous studies have demonstrated that the heating, ventilation, and air conditioning (HVAC) system plays a large role in emissions.8,11 This can easily be fixed by “HVAC setbacks” and powering down rooms when not in use. One institution powered down ORs when not in use and reduced 234 metric tons of CO2 emissions and saved $33,000 per year.14 Transitioning to light-emitting diode (LED) lights reduced energy usage at 1 institution by almost 50%.15 Finally, computers in clinical offices, examination rooms, and administrative offices can be powered down at the end of the day. One study found that in 1 radiology department, 29 computers left on overnight and on weekends emitted 17.7 tons of CO2 emissions in 1 year.16

Bottom line: We as ObGyns can advocate for how energy can be saved outside of surgical cases, including powering down ORs and LD units, transitioning to LED lighting, and powering down workstations.

Reuse

4. Choose reusable equipment

In ObGyn practice, the most commonly used tool is the speculum. Given its omnipresence, the speculum is a great place to start to decrease our carbon footprint. Two studies have evaluated the environmental impact of reusable versus single-use disposable specula, and both demonstrated that the stainless-steel versions have less global warming potential than the acrylic varieties.17,18 Donahue and colleagues17 demonstrated that it only took 2 to 3 pelvic examinations for the cost of stainless-steel specula to break even, even when sterilized in a half-filled autoclave tray. Rodriquez, et al18 revealed that, compared with an acrylic model, the stainless-steel specula had fewer negative impacts in terms of global warming, acidification, respiratory effects, smog, and fossil fuel depletion.18

Bottom line: Strongly consider using stainless-steel specula to reduce costs and carbon emissions.

 

 

In addition to specula, ObGyns can choose reusable equipment in the OR. For example, surgeons can use stainless-steel trocars instead of disposable trocars.19 In vaginal cases, Breisky-Navratil retractors can be used instead of disposable self-retaining retractors. Plastic basins that often are included in sterile supply packs can be replaced with stainless-steel basins, which could have profound positive effects on the carbon footprint of gynecologic surgery.8 One study of ObGyns demonstrated that 95% of physicians supported waste-reduction efforts, and 66% supported utilizing reusable surgical tools instead of disposable tools.20

Bottom line: As surgeons, ObGyns have influence over what they want to use in the OR, and they can petition for reusable options over disposable options.

5. Launder the sterile blue towels

Sterile blue towels, which are made of cotton, have the largest environmental footprint compared with other disposable materials, such as plastics, and contribute greatly to toxicity in human health.8,11 Although these towels cannot be laundered and sterilized again for use in a sterile surgical field, they can be laundered and repurposed, including by environmental services to clean hospital rooms. Blue towels should be able to be laundered no matter how saturated in body fluids they are.

Bottom line: ObGyns should strive to always launder the blue towels and educate trainees and other staff in the OR to do the same.

Recycle

6. Recycle and reprocess materials and devices

While recycling is immensely important, it requires a large amount of energy to break down a material to its raw components for manufacturing. It likely reduces our carbon footprint from OR procedures by only 5%.8 However, recycling is still a good way to divert appropriate materials from landfill, saving costs and emissions at the end of a material’s life. One example is sterile blue wrap, which is a petroleum product with a recycling number of 6 and a filtration rating of N99. Blue wrap can be recycled into plastic pellets, or it can be recreated into other hospital supplies, such as gowns.

Bottom line: ObGyns can petition their hospitals to work with suppliers and waste-processing companies who have recycling programs built into their supply chains.

By contrast, reprocessing can have a much larger impact on carbon emissions. Complex items, such as advanced energy devices that can be reprocessed, result in a greater reduction in carbon emissions due to the reuse of their complex materials and manufacturing when compared with such devices that cannot be reprocessed. Recycling and reprocessing programs are already in place for several devices (TABLE). Authors of a systematic review showed that there is no evidence to support the use of single-use supplies and instruments over reprocessed items when considering instrument function, ease of use, patient safety, transmission of infection, or long-term patient outcomes.21

Bottom line: ObGyns can choose to use reprocessed items in ORs instead of single-use devices and educate staff on the safety of these items.

Continue to: Remove...

 

 

Remove

7. Remove desflurane and other volatile gases from formularies

Volatile anesthetic gases, such as desflurane, isoflurane, and nitrous oxide, are themselves potent greenhouse gases, comprising a large portion of the carbon emissions that come from the OR.22 Desflurane was developed to have a rapid onset for induction and quick recovery; however, studies have shown no clinical benefit over other gases.23 Furthermore, the costs and greenhouse gas potential are substantial. Desflurane costs 2 to 3 times more and has more than 20 times the global warming potential of the other volatile gases (FIGURE).8 Using 1 hour of desflurane is equivalent to driving 378 miles in a gas-powered vehicle, while the use of isoflurane and sevoflurane create equivalents of only 15 and 8 miles, respectively.23

Nitrous oxide is another powerful greenhouse gas that is a direct ozone depletor and can stay in the atmosphere for 114 years.22 Nitrous oxide has limited clinical use in hospitals, but it is often stored in central hospital piping. Most of the impact of nitrous oxide comes through leaks in a poor system design rather than patient delivery. One estimate reveals that more than 13 million liters of nitrous oxide are lost annually from leaks in European hospitals.22 The American Society of Anesthesiologists recommends decommissioning central piping of nitrous oxide in favor of cylinders at the point of care.24

Literature on enhanced recovery after surgery in gynecology promotes the use of propofol over volatile gases for our patients because of the high rate of postoperative nausea and vomiting seen with gases.25 Volatile gases should be a last-choice anesthetic for our patients.

Bottom line: It is critical that ObGyns work with colleagues in anesthesia to develop climate- and patient-friendly protocols for procedures.

 

 

8. Remove endocrine-disrupting chemicals from clinical supplies

Endocrine-disrupting chemicals (EDCs) are a type of chemical that alter the hormonal systems of humans, which can result in adverse health effects. Multiple studies and reviews have tied EDCs to reproductive abnormalities, such as the effects of bisphenol A (BPA) on estradiol levels, antral follicle counts, oocyte quality, and implantation rates; phthalates on fibroid burden; triclosan on embryo quality; parabens on live birth rates; and perfluoroalkylsubstances (PFAS or “forever substances”) on hypertensive disorders of pregnancy.5,26,27

What might be most shocking is that these EDCs are incorporated into medical supplies and pharmaceuticals. For example, BPA is known to line dialysis and ointment tubes, parabens are used for their antimicrobial properties in ultrasound gel and hep-locks, and phthalates are found in up to 40% of medical-use plastics and controlled-release medications. Authors of an observational study found that 74% of patients admitted to an LD unit were exposed to EDCs. In a neonatal intensive care unit (NICU), most of the supplies contained an EDC, and urinary BPA levels were elevated in neonates admitted to a NICU, raising concerns about long-term health risks.5

Bottom line: Physicians and health care institutions have an obligation to petition industry partners and suppliers to remove EDCs from their supply chains.

Reimagine

9. Educate

The field of health care sustainability remains in its infancy, but from 2007 to 2019, publications on climate change and health in academia increased by a factor of 8.29 Additionally, through waste audits, quality-improvement projects, and life cycle analyses (analytical tools to evaluate product or process emissions from materials extraction to disposal), we have gained insight into the scope of the problem, with evidence showing that our practices are largely derived from culture. It is time to provide formal education on health care sustainability to medical trainees, staff, and clinicians alike, who desire to see this topic reflected in their formal curricula.30 Start talking about it!

Bottom line: Commentaries, webinars, formal didactics sessions, in-services, and hospital workgroups to introduce this topic are a good way to teach others about the carbon footprint of our care and solutions to minimize it.

10. Engage in advocacy

Physicians have an ethical duty to advocate for change at the local, regional, and national levels if we want to see a better future for our patients, their children, and even ourselves. We should reimagine this work as an important public health initiative.31 Surveys of physicians, including ObGyns, reveal a concern about the sustainability of health care and a commitment to addressing this issue.20 ObGyns are on the frontlines of delivering care every day, so we are poised to implement changes that can impact our patients, especially when we can lead and petition hospital or local committees.20,28,32 There is much to be done, but every voice counts and can make impactful changes at every level. ●

 

Climate change has been called the biggest health threat of the 21st century.1 The health care sector is a huge contributor to global carbon emissions, accounting for almost double the emissions of global aviation. While other industries and countries are implementing mitigation measures to decrease their emissions, health care is currently on track to double its carbon emissions by 2050, even though it should be carbon neutral by that time to comply with the Paris Climate Agreement.2 There have been some national efforts to curb health care emissions, including the creation of the Office of Climate Change and Health Equity in 2021 and the passage of the Inflation Reduction Act in 2022.3 These are top-down, administrative approaches, and to be successful we will also need clinicians to understand and address this problem.

The negative impacts of heat, air pollution, and exposure to toxic substances on human health have been well documented in multiple regions across multiple specialties.4-7 The United States makes up 27% of the global health care carbon footprint—more emissions than the entire United Kingdom as a country—despite having only 4% of the world’s population.2 Culture and incentives for an overabundance of single-use supplies, not evidence for patient safety, have led to this uniquely American problem. It is evident that our health care industry is an excellent place to implement mitigation measures for carbon emissions that contribute to climate change and can improve health outcomes.

In this article, we recommend 10 practices that can decrease our carbon footprint in ObGyn. We focus on the classic motto of “Reduce, Reuse, Recycle,” while adding “Remove” and “Reimagine” to classify the ways in which we can reduce emissions while not compromising our care to patients.

Reduce

1. Minimize opened materials and single-use devices in the OR and labor and delivery

Health care is a unique setting where a culture of infection prevention and efficiency has led low-cost, single-use supplies to dominate over reusable items. While single-use items can have inexpensive purchasing costs compared to reusable items, the environmental costs required for the production and disposal of the former are often much greater. In operating rooms (ORs) and labor and delivery (LD) units, single-use items are omnipresent. Over the past decade, researchers and clinicians have started to take a closer look at these items and their carbon footprint. One group evaluated hysterectomy through a waste audit and found that the vast majority of waste from all of the cases was Spunbond Meltblown Spunbond, or SMS; plastic materialthat comprises gowns; blue wraps; and drapes; followed by hard plastic material that comprises trays and packaging.8 Moreover, production and manufacturing processes contributed to 95% of the environmental impacts of these items.8

In an effort to be time efficient, OR staff will open sterile surgical packs and individual peel-pack items prior to surgery to minimize having to find items during surgery. However, this creates an inordinate amount of waste. One group of neurosurgeons who evaluated their opened but unused supplies found that 85% of their unused items were individually opened items, leading to a waste of $2.9 million per year.9 Minor procedures like dilation and curettage, cystoscopy, and hysteroscopy do not need such a large sterile field, as these procedures are also safe to perform in the office. Hand surgeons have been quick to lead in this space, particularly with minor procedures such as carpal tunnel release. One division was able to eliminate 2.8 tons of waste and save $13,000 in a 2-year period by reducing the sterile field.10 ObGyns can work with OR and LD staff to create custom packs that minimize unused or underutilized items, helping to reduce both the carbon footprint and health care spending.

Bottom line: ObGyns can help foster a culture of having supplies available but not opened until needed during a case.

 

 

Continue to: 2. Decrease regulated medical waste...

 

 

2. Decrease regulated medical waste

Health care is unique from other fields in that there are multiple waste streams to consider. Infectious waste and items saturated in blood or capable of causing infection must be placed into regulated medical waste (RMW), or more commonly, red biohazard bags. RMW is autoclaved or incinerated prior to disposal in a landfill. This process is more financially and environmentally costly than general municipal waste (GMW). This process also requires more transport—1 study revealed that GMW traveled 20 km to a landfill for disposal, compared with the 50 km that RMW traveled for sterilized-prior-to-landfill disposal.11

Unfortunately, the vast majority of items placed in RMW are incorrectly triaged and should instead be disposed in GMW.12,13 One study performed in an emergency department revealed that 85% of waste was incorrectly placed in the RMW.12

Bottom line: ObGyns can avoid placing items in RMW that may not qualify and advocate for institution policy changes to remove RMW from places such as waiting rooms, at the patient bedside, or next to scrub sinks.

3. Reduce energy use

ORs and LD units use a lot of energy, and numerous studies have demonstrated that the heating, ventilation, and air conditioning (HVAC) system plays a large role in emissions.8,11 This can easily be fixed by “HVAC setbacks” and powering down rooms when not in use. One institution powered down ORs when not in use and reduced 234 metric tons of CO2 emissions and saved $33,000 per year.14 Transitioning to light-emitting diode (LED) lights reduced energy usage at 1 institution by almost 50%.15 Finally, computers in clinical offices, examination rooms, and administrative offices can be powered down at the end of the day. One study found that in 1 radiology department, 29 computers left on overnight and on weekends emitted 17.7 tons of CO2 emissions in 1 year.16

Bottom line: We as ObGyns can advocate for how energy can be saved outside of surgical cases, including powering down ORs and LD units, transitioning to LED lighting, and powering down workstations.

Reuse

4. Choose reusable equipment

In ObGyn practice, the most commonly used tool is the speculum. Given its omnipresence, the speculum is a great place to start to decrease our carbon footprint. Two studies have evaluated the environmental impact of reusable versus single-use disposable specula, and both demonstrated that the stainless-steel versions have less global warming potential than the acrylic varieties.17,18 Donahue and colleagues17 demonstrated that it only took 2 to 3 pelvic examinations for the cost of stainless-steel specula to break even, even when sterilized in a half-filled autoclave tray. Rodriquez, et al18 revealed that, compared with an acrylic model, the stainless-steel specula had fewer negative impacts in terms of global warming, acidification, respiratory effects, smog, and fossil fuel depletion.18

Bottom line: Strongly consider using stainless-steel specula to reduce costs and carbon emissions.

 

 

In addition to specula, ObGyns can choose reusable equipment in the OR. For example, surgeons can use stainless-steel trocars instead of disposable trocars.19 In vaginal cases, Breisky-Navratil retractors can be used instead of disposable self-retaining retractors. Plastic basins that often are included in sterile supply packs can be replaced with stainless-steel basins, which could have profound positive effects on the carbon footprint of gynecologic surgery.8 One study of ObGyns demonstrated that 95% of physicians supported waste-reduction efforts, and 66% supported utilizing reusable surgical tools instead of disposable tools.20

Bottom line: As surgeons, ObGyns have influence over what they want to use in the OR, and they can petition for reusable options over disposable options.

5. Launder the sterile blue towels

Sterile blue towels, which are made of cotton, have the largest environmental footprint compared with other disposable materials, such as plastics, and contribute greatly to toxicity in human health.8,11 Although these towels cannot be laundered and sterilized again for use in a sterile surgical field, they can be laundered and repurposed, including by environmental services to clean hospital rooms. Blue towels should be able to be laundered no matter how saturated in body fluids they are.

Bottom line: ObGyns should strive to always launder the blue towels and educate trainees and other staff in the OR to do the same.

Recycle

6. Recycle and reprocess materials and devices

While recycling is immensely important, it requires a large amount of energy to break down a material to its raw components for manufacturing. It likely reduces our carbon footprint from OR procedures by only 5%.8 However, recycling is still a good way to divert appropriate materials from landfill, saving costs and emissions at the end of a material’s life. One example is sterile blue wrap, which is a petroleum product with a recycling number of 6 and a filtration rating of N99. Blue wrap can be recycled into plastic pellets, or it can be recreated into other hospital supplies, such as gowns.

Bottom line: ObGyns can petition their hospitals to work with suppliers and waste-processing companies who have recycling programs built into their supply chains.

By contrast, reprocessing can have a much larger impact on carbon emissions. Complex items, such as advanced energy devices that can be reprocessed, result in a greater reduction in carbon emissions due to the reuse of their complex materials and manufacturing when compared with such devices that cannot be reprocessed. Recycling and reprocessing programs are already in place for several devices (TABLE). Authors of a systematic review showed that there is no evidence to support the use of single-use supplies and instruments over reprocessed items when considering instrument function, ease of use, patient safety, transmission of infection, or long-term patient outcomes.21

Bottom line: ObGyns can choose to use reprocessed items in ORs instead of single-use devices and educate staff on the safety of these items.

Continue to: Remove...

 

 

Remove

7. Remove desflurane and other volatile gases from formularies

Volatile anesthetic gases, such as desflurane, isoflurane, and nitrous oxide, are themselves potent greenhouse gases, comprising a large portion of the carbon emissions that come from the OR.22 Desflurane was developed to have a rapid onset for induction and quick recovery; however, studies have shown no clinical benefit over other gases.23 Furthermore, the costs and greenhouse gas potential are substantial. Desflurane costs 2 to 3 times more and has more than 20 times the global warming potential of the other volatile gases (FIGURE).8 Using 1 hour of desflurane is equivalent to driving 378 miles in a gas-powered vehicle, while the use of isoflurane and sevoflurane create equivalents of only 15 and 8 miles, respectively.23

Nitrous oxide is another powerful greenhouse gas that is a direct ozone depletor and can stay in the atmosphere for 114 years.22 Nitrous oxide has limited clinical use in hospitals, but it is often stored in central hospital piping. Most of the impact of nitrous oxide comes through leaks in a poor system design rather than patient delivery. One estimate reveals that more than 13 million liters of nitrous oxide are lost annually from leaks in European hospitals.22 The American Society of Anesthesiologists recommends decommissioning central piping of nitrous oxide in favor of cylinders at the point of care.24

Literature on enhanced recovery after surgery in gynecology promotes the use of propofol over volatile gases for our patients because of the high rate of postoperative nausea and vomiting seen with gases.25 Volatile gases should be a last-choice anesthetic for our patients.

Bottom line: It is critical that ObGyns work with colleagues in anesthesia to develop climate- and patient-friendly protocols for procedures.

 

 

8. Remove endocrine-disrupting chemicals from clinical supplies

Endocrine-disrupting chemicals (EDCs) are a type of chemical that alter the hormonal systems of humans, which can result in adverse health effects. Multiple studies and reviews have tied EDCs to reproductive abnormalities, such as the effects of bisphenol A (BPA) on estradiol levels, antral follicle counts, oocyte quality, and implantation rates; phthalates on fibroid burden; triclosan on embryo quality; parabens on live birth rates; and perfluoroalkylsubstances (PFAS or “forever substances”) on hypertensive disorders of pregnancy.5,26,27

What might be most shocking is that these EDCs are incorporated into medical supplies and pharmaceuticals. For example, BPA is known to line dialysis and ointment tubes, parabens are used for their antimicrobial properties in ultrasound gel and hep-locks, and phthalates are found in up to 40% of medical-use plastics and controlled-release medications. Authors of an observational study found that 74% of patients admitted to an LD unit were exposed to EDCs. In a neonatal intensive care unit (NICU), most of the supplies contained an EDC, and urinary BPA levels were elevated in neonates admitted to a NICU, raising concerns about long-term health risks.5

Bottom line: Physicians and health care institutions have an obligation to petition industry partners and suppliers to remove EDCs from their supply chains.

Reimagine

9. Educate

The field of health care sustainability remains in its infancy, but from 2007 to 2019, publications on climate change and health in academia increased by a factor of 8.29 Additionally, through waste audits, quality-improvement projects, and life cycle analyses (analytical tools to evaluate product or process emissions from materials extraction to disposal), we have gained insight into the scope of the problem, with evidence showing that our practices are largely derived from culture. It is time to provide formal education on health care sustainability to medical trainees, staff, and clinicians alike, who desire to see this topic reflected in their formal curricula.30 Start talking about it!

Bottom line: Commentaries, webinars, formal didactics sessions, in-services, and hospital workgroups to introduce this topic are a good way to teach others about the carbon footprint of our care and solutions to minimize it.

10. Engage in advocacy

Physicians have an ethical duty to advocate for change at the local, regional, and national levels if we want to see a better future for our patients, their children, and even ourselves. We should reimagine this work as an important public health initiative.31 Surveys of physicians, including ObGyns, reveal a concern about the sustainability of health care and a commitment to addressing this issue.20 ObGyns are on the frontlines of delivering care every day, so we are poised to implement changes that can impact our patients, especially when we can lead and petition hospital or local committees.20,28,32 There is much to be done, but every voice counts and can make impactful changes at every level. ●

References
  1. Costello A, Abbas M, Allen et al. Managing the health effects of climate change: Lancet and University College London Institute for Global Health Commission. Lancet. 2009;373:1693-1733.
  2. Health care climate footprint report. Health Care Without Harm website. https://www.noharm.org/ClimateFootprintReport. Accessed May 12, 2023.
  3. Balbus JM, McCannon CJ, Mataka A, et al. After COP26—putting health and equity at the center of the climate movement. N Engl J Med. 2022;386:1295-1297.
  4. Bekkar B, Pacheco S, Basu R, et al. Association of air pollution and heat exposure with preterm birth, low birth weight, and stillbirth in the US: a systematic review. JAMA Netw Open. 2020;3:e208243.
  5. Genco M, Anderson-Shaw L, Sargis RM. Unwitting accomplices: endocrine disruptors confounding clinical care. J Clin Endocrinol Metab. 2020;105:e3822-e3827.
  6. Al-Kindi SG, Sarode A, Zullo M, et al. Ambient air pollution and mortality after cardiac transplantation. J Am Coll Cardiol. 2019;74:30263035.
  7. Ghosh R, Gauderman WJ, Minor H, et al. Air pollution, weight loss and metabolic benefits of bariatric surgery: a potential model for study of metabolic effects of environmental exposures. Pediatr Obes. 2018;13:312-320.
  8. Thiel CL, Eckelman M, Guido R, et al. Environmental impacts of surgical procedures: life cycle assessment of hysterectomy in the United States. Environ Sci Technol. 2015;49:1779-1786.
  9. Zygourakis CC, Yoon S, Valencia V, et al. Operating room waste: disposable supply utilization in neurosurgical procedures. J Neurosurg. 2017;126:620-625.
  10. van Demark RE, Smith VJS, Fiegen A. Lean and green hand surgery. J Hand Surg. 2018;43:179-181.
  11. Campion N, Thiel CL, DeBlois J, et al. Life cycle assessment perspectives on delivering an infant in the US. Sci Total Environ. 2012;425:191198.
  12. Hsu S, Thiel CL, Mello MJ, Slutzman JE. Dumpster diving in the emergency department. West J Emerg Med. 2020;21:1211-1217.
  13. Mcgain F, Story D, Hendel S. An audit of intensive care unit recyclable waste. Anaesthesia. 2009;64:1299-1302.
  14. Wormer BA, Augenstein VA, Carpenter CL, et al. The green operating room: simple changes to reduce cost and our carbon footprint. Am Surg. 2013;79:666-671.
  15. Kagoma Y, Stall N, Rubinstein E, et al. People, planet and profits: the case for greening operating rooms. Can Med Assoc J. 2012;184:19051911.
  16. McCarthy CJ, Gerstenmaier JF, O’ Neill AC, et al. “EcoRadiology”— pulling the plug on wasted energy in the radiology department. Acad Radiol. 2014;21:1563-1566.
  17. Donahue LM, Hilton S, Bell SG, et al. A comparative carbon footprint analysis of disposable and reusable vaginal specula. Am J Obstet  Gynecol. 2020;223:225.e1-225.e7.
  18. Rodriguez Morris MI, Hicks A. Life cycle assessment of stainless-steel reusable speculums versus disposable acrylic speculums in a university clinic setting: a case study. Environ Res Commun. 2022;4:025002.
  19. MacNeill AJ, Lillywhite R, Brown CJ. The impact of surgery on global climate: a carbon footprinting study of operating theatres in three health systems. Lancet Planet Health. 2017;1:e381-e388.
  20. Thiel C, Duncan P, Woods N. Attitude of US obstetricians and gynaecologists to global warming and medical waste. J Health Serv Res Policy. 2017;22:162-167.
  21. Siu J, Hill AG, MacCormick AD. Systematic review of reusable versus disposable laparoscopic instruments: costs and safety. ANZ J Surg. 2017;87:28-33.
  22. Ryan SM, Nielsen CJ. Global warming potential of inhaled anesthetics: application to clinical use. Anesth Analg. 2010;111:92-98.
  23. Meyer MJ. Desflurane should des-appear: global and financial rationale. Anesth Analg. 2020;131:1317-1322.
  24. Rollins MD, Arendt KW, Carvalho B, et al. ASA Committee on Obstetric Anesthesia Working Group. Nitrous oxide. American Society of Anesthesiologists website. Accessed May 12, 2023. https://www .asahq.org/about-asa/governance-and-committees/asa-committees /committee-on-obstetric-anesthesia/nitrous-oxide.
  25. Kalogera E, Dowdy SC. Enhanced recovery pathway in gynecologic surgery: improving outcomes through evidence-based medicine. Obstet Gynecol Clin North Am. 2016;43:551-573.
  26. Zota AR, Geller RJ, Calafat AM, et al. Phthalates exposure and uterine fibroid burden among women undergoing surgical treatment for fibroids: a preliminary study. Fertil Steril. 2019;111:112-121.
  27.  Bommartio PA, Ferguson KK, Meeker JD, et al. Maternal levels of perfluoroalkyl substances (PFAS) during early pregnancy in relation to preeclampsia subtypes and biomarkers of preeclampsia risk. Environ Health Perspect. 2021;129:107004.
  28. Azouz S, Boyll P, Swanson M, et al. Managing barriers to recycling in the operating room. Am J Surg. 2019;217:634-638.
  29. Watts N, Amann M, Arnell N, et al. The 2020 report of The Lancet Countdown on health and climate change: responding to converging crises. Lancet. 2021;397:129-170.
  30. Ryan EC, Dubrow R, Sherman JD. Medical, nursing, and physician assistant student knowledge and attitudes toward climate change, pollution, and resource conservation in health care. BMC Med Educ. 2020;20:200.
  31. Giudice LC, Llamas-Clark EF, DeNicola Net al; FIGO Committee on Climate Change and Toxic Environmental Exposures. Climate change, women’s health, and the role of obstetricians and gynecologists in leadership. Int J Gynaecol Obstet. 2021;155:345-356.
  32. Yates EF, Bowder AN, Roa L, et al. Empowering surgeons, anesthesiologists, and obstetricians to incorporate environmental sustainability in the operating room. Ann Surg. 2021;273:1108-1114. 
References
  1. Costello A, Abbas M, Allen et al. Managing the health effects of climate change: Lancet and University College London Institute for Global Health Commission. Lancet. 2009;373:1693-1733.
  2. Health care climate footprint report. Health Care Without Harm website. https://www.noharm.org/ClimateFootprintReport. Accessed May 12, 2023.
  3. Balbus JM, McCannon CJ, Mataka A, et al. After COP26—putting health and equity at the center of the climate movement. N Engl J Med. 2022;386:1295-1297.
  4. Bekkar B, Pacheco S, Basu R, et al. Association of air pollution and heat exposure with preterm birth, low birth weight, and stillbirth in the US: a systematic review. JAMA Netw Open. 2020;3:e208243.
  5. Genco M, Anderson-Shaw L, Sargis RM. Unwitting accomplices: endocrine disruptors confounding clinical care. J Clin Endocrinol Metab. 2020;105:e3822-e3827.
  6. Al-Kindi SG, Sarode A, Zullo M, et al. Ambient air pollution and mortality after cardiac transplantation. J Am Coll Cardiol. 2019;74:30263035.
  7. Ghosh R, Gauderman WJ, Minor H, et al. Air pollution, weight loss and metabolic benefits of bariatric surgery: a potential model for study of metabolic effects of environmental exposures. Pediatr Obes. 2018;13:312-320.
  8. Thiel CL, Eckelman M, Guido R, et al. Environmental impacts of surgical procedures: life cycle assessment of hysterectomy in the United States. Environ Sci Technol. 2015;49:1779-1786.
  9. Zygourakis CC, Yoon S, Valencia V, et al. Operating room waste: disposable supply utilization in neurosurgical procedures. J Neurosurg. 2017;126:620-625.
  10. van Demark RE, Smith VJS, Fiegen A. Lean and green hand surgery. J Hand Surg. 2018;43:179-181.
  11. Campion N, Thiel CL, DeBlois J, et al. Life cycle assessment perspectives on delivering an infant in the US. Sci Total Environ. 2012;425:191198.
  12. Hsu S, Thiel CL, Mello MJ, Slutzman JE. Dumpster diving in the emergency department. West J Emerg Med. 2020;21:1211-1217.
  13. Mcgain F, Story D, Hendel S. An audit of intensive care unit recyclable waste. Anaesthesia. 2009;64:1299-1302.
  14. Wormer BA, Augenstein VA, Carpenter CL, et al. The green operating room: simple changes to reduce cost and our carbon footprint. Am Surg. 2013;79:666-671.
  15. Kagoma Y, Stall N, Rubinstein E, et al. People, planet and profits: the case for greening operating rooms. Can Med Assoc J. 2012;184:19051911.
  16. McCarthy CJ, Gerstenmaier JF, O’ Neill AC, et al. “EcoRadiology”— pulling the plug on wasted energy in the radiology department. Acad Radiol. 2014;21:1563-1566.
  17. Donahue LM, Hilton S, Bell SG, et al. A comparative carbon footprint analysis of disposable and reusable vaginal specula. Am J Obstet  Gynecol. 2020;223:225.e1-225.e7.
  18. Rodriguez Morris MI, Hicks A. Life cycle assessment of stainless-steel reusable speculums versus disposable acrylic speculums in a university clinic setting: a case study. Environ Res Commun. 2022;4:025002.
  19. MacNeill AJ, Lillywhite R, Brown CJ. The impact of surgery on global climate: a carbon footprinting study of operating theatres in three health systems. Lancet Planet Health. 2017;1:e381-e388.
  20. Thiel C, Duncan P, Woods N. Attitude of US obstetricians and gynaecologists to global warming and medical waste. J Health Serv Res Policy. 2017;22:162-167.
  21. Siu J, Hill AG, MacCormick AD. Systematic review of reusable versus disposable laparoscopic instruments: costs and safety. ANZ J Surg. 2017;87:28-33.
  22. Ryan SM, Nielsen CJ. Global warming potential of inhaled anesthetics: application to clinical use. Anesth Analg. 2010;111:92-98.
  23. Meyer MJ. Desflurane should des-appear: global and financial rationale. Anesth Analg. 2020;131:1317-1322.
  24. Rollins MD, Arendt KW, Carvalho B, et al. ASA Committee on Obstetric Anesthesia Working Group. Nitrous oxide. American Society of Anesthesiologists website. Accessed May 12, 2023. https://www .asahq.org/about-asa/governance-and-committees/asa-committees /committee-on-obstetric-anesthesia/nitrous-oxide.
  25. Kalogera E, Dowdy SC. Enhanced recovery pathway in gynecologic surgery: improving outcomes through evidence-based medicine. Obstet Gynecol Clin North Am. 2016;43:551-573.
  26. Zota AR, Geller RJ, Calafat AM, et al. Phthalates exposure and uterine fibroid burden among women undergoing surgical treatment for fibroids: a preliminary study. Fertil Steril. 2019;111:112-121.
  27.  Bommartio PA, Ferguson KK, Meeker JD, et al. Maternal levels of perfluoroalkyl substances (PFAS) during early pregnancy in relation to preeclampsia subtypes and biomarkers of preeclampsia risk. Environ Health Perspect. 2021;129:107004.
  28. Azouz S, Boyll P, Swanson M, et al. Managing barriers to recycling in the operating room. Am J Surg. 2019;217:634-638.
  29. Watts N, Amann M, Arnell N, et al. The 2020 report of The Lancet Countdown on health and climate change: responding to converging crises. Lancet. 2021;397:129-170.
  30. Ryan EC, Dubrow R, Sherman JD. Medical, nursing, and physician assistant student knowledge and attitudes toward climate change, pollution, and resource conservation in health care. BMC Med Educ. 2020;20:200.
  31. Giudice LC, Llamas-Clark EF, DeNicola Net al; FIGO Committee on Climate Change and Toxic Environmental Exposures. Climate change, women’s health, and the role of obstetricians and gynecologists in leadership. Int J Gynaecol Obstet. 2021;155:345-356.
  32. Yates EF, Bowder AN, Roa L, et al. Empowering surgeons, anesthesiologists, and obstetricians to incorporate environmental sustainability in the operating room. Ann Surg. 2021;273:1108-1114. 
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Did ob.gyn. residencies take a hit from abortion bans?

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Fri, 06/16/2023 - 11:39

Emilee Gibson, MD, recently graduated from Southern Illinois University, Springfield, and starts her ob.gyn. residency at Vanderbilt University Medical Center in Nashville, Tenn., later this month. Abortion is permitted in Illinois but banned in Tennessee, a factor she weighed cautiously when she applied for residencies.

Dr. Gibson told this news organization that medical students, not just those interested in ob.gyn., are starting to think more about what it means to move to a state where it might be difficult to access abortion care. “Just from a personal standpoint, that’s a little scary.”

The Supreme Court’s decision to overturn Roe v. Wade abortion rights last June threatened to derail ob.gyns. in training from pursuing the specialty or locating in states that have banned or limited abortion.

Early signals from the Dobbs v. Jackson decision suggest a potential decline in ob.gyn. residents choosing abortion-restrictive states, but some industry leaders, residents, and medical students say it may be too early to judge the full impact of the ruling because most students were already far along in their decision and application for a 2023 residency position.

At this point, some ob.gyn. students are planning careers on the basis of whether they have family ties in a particular state, whether limiting their search might hurt their potential to match in a competitive specialty, and whether their faith in the family planning and abortion training being offered by a program outweighs the drawbacks of being in a state with abortion bans or restrictions.

Lucy Brown, MD, a recent graduate of Indiana University, Indianapolis, said in an interview that she’d be “very nervous” about living and practicing in abortion-restricted Indiana if she were ready to start a family.

Dr. Brown said that she mostly limited applications in the recent Match to ob.gyn. residencies in states that protected abortion rights. Though she applied to a program in her home state of Kentucky, she noted that it – along with a program in Missouri – was very low on her rank list because of their abortion restrictions.

Ultimately, Dr. Brown matched at Johns Hopkins University, Baltimore, where she will receive abortion training and assist with abortions throughout her residency. Maryland’s abortion rights status was a big attraction, she said. “Abortion is integrated into every aspect of the education.”
 

By the numbers

For students applying to residencies this summer, evaluating the state legislative landscape is a little clearer than it was 1 year ago but is still evolving. As of June 1, 56 ob.gyn. residency programs and more than 1,100 medical residents are in states with the most restrictive bans in the country (19% of all programs), according to the Bixby Center for Reproductive Health at the University of California, San Francisco.

In terms of the latest abortion laws: 14 states banned abortion, 2 states banned abortion between 6 and 12 weeks, and 9 states banned abortion between 15 and 22 weeks, whereas abortion is legal in 25 states and Washington, according to a recent analysis by the Kaiser Family Foundation.

The impact on residencies? The Association of American Medical Colleges recently reported a 2% drop in the number of U.S. MD seniors who applied to residencies and a 5% decline in the number of seniors who applied to ob.gyn. residencies. In states where abortion was banned, the number of senior applicants to ob.gyn. programs dropped by more than 10%, according to AAMC’s Research and Action Institute.

“U.S. MD seniors appear, in general, more likely to avoid states where abortions are banned,” said Atul Grover, MD, PhD, executive director of the Research and Action Institute. “That’s a big difference between states where there are abortion bans and gestational limits and states with no bans or limits; it’s almost twice as large,” Dr. Grover said in an interview. “The question is: Was it a 1-year blip or something that will be the beginning of a trend?”

In a statement to this news organization, officials from the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said that they were aware of the AAMC data but needed to further evaluate the impact of the Dobbs ruling.

A survey released at ACOG’s annual meeting in May found that 58% of third- and fourth-year medical students were unlikely to apply to a residency program in a state with abortion restrictions. Conducted after the Dobbs ruling last year, the survey found that future physicians are choosing where to attend residency according to state abortion policies, indicating that access to abortion care is changing the landscape of medical practice.

“For personal as well as professional reasons, reproductive health care access is now a key factor in residency match decisions as a result of Dobbs,” lead author Ariana Traub, MPH, said. She studies at Emory University, Atlanta, where abortion is restricted.

“Many students, including myself, struggle when trying to decide whether to stay in restricted states where the need is greatest (highest maternal mortality, infant mortality, lower number of physicians), versus going to an unrestricted state” for more comprehensive training and care, Ms. Traub said. “Regardless of this decision, Dobbs and subsequent abortion laws are making students question what matters most and how they can provide the best care.”

In another recently published survey, University of Miami fourth-year student Morgan Levy, MD, MPH, and colleagues found that 77% of students would prefer to apply to a residency program in a state that preserves access to abortion. Ensuring access to those services for themselves or a family member was a key factor, according to the paper published in the Journal of General Internal Medicine.

For Dr. Levy, who recently graduated from a school in abortion-restricted Florida and will soon apply to ob.gyn. residencies, the Dobbs decision made her more committed to becoming an ob.gyn., an interest she’s had since college, she said.

“I do not intend to limit my search,” Dr. Levy said in an interview. “In the states where there are restrictions in place, it’s really important to make sure that people are getting good care,” she said.
 

 

 

Differing perspective

Though survey and anecdotal data show that students and residents expressing hesitation about states with bans or restrictive laws, it appears that most who applied to residency programs during the 2023 Match did not shy away from those states. Almost all the open ob.gyn. residency positions were filled, according to the National Resident Matching Program.

There was no change in how U.S. MD seniors applying for 2023 residency ranked programs on the basis of whether abortion was legal, limited, or banned in the state where a program was based, Donna Lamb, DHSc, MBA, BSN, president and CEO of the NRMP, said.

“We’re seeing what we’ve seen over the past 5 years, and that is a very high fill rate, a very high rate of preference for ob.gyn., and not a heck of a lot of change,” Dr. Lamb said, noting that ob.gyn. programs continue to be very competitive. “We have more applicants than we have positions available,” she said.

In the most recent Match, there were 2,100 applicants (more than half U.S. MD seniors) for about 1,500 slots, with 1,499 initial matches, according to NRMP data. The overall fill rate was 99.7% after the Supplemental Offer and Assistance Program and Electronic Residency Applications process, NRMP reported. The results are similar to what NRMP reported as its previous all-time high year for ob.gyn. placements.

There was a dip in applicants from 2022 to 2023, even though the slots available stayed the same, but it was not markedly different from the previous 5 years, Dr. Lamb said.

“While the Dobbs decision may, indeed, have impacted applicant and application numbers to residency programs, interventions such as signaling may also contribute to the decrease in numbers of applications submitted as well,” AnnaMarie Connolly, MD, ACOG chief of education and academic affairs, and Arthur Ollendorff, MD, APOG president, said in a statement to this news organization.

For the first time in 2022, Match Day applicants were required to “signal” interest in a particular program in an effort to reduce the number of applications and cost to medical students, they noted.
 

Personal view

When it was time for Dr. Gibson to apply for ob.gyn. residencies, she wondered: Where do you apply in this landscape? But she did not limit her applications: “If I don’t apply to Indiana, Missouri, Tennessee, Wisconsin, Iowa, I’m taking a lot of really great programs off the table.” She did not want to hurt her chances for a match in a competitive specialty, she said.

“Being in Tennessee is going to give me a very different, unique opportunity to hopefully do a lot of advocacy and lobbying and hopefully have my voice heard in maybe a different way than [in Illinois],” Dr. Gibson added.

Cassie Crifase, MPH, a fourth-year student at the University of Wisconsin–Madison applying to ob.gyn. residencies in next year’s Match, said in an interview that she’s concerned about the health risk of living in a state with abortion restrictions. Wisconsin is one of those.

“My list skews toward programs that are in abortion-protected states, but I also am applying to some programs that are in restricted states.” Those states would have to help her meet the Accreditation Council for Graduate Medical Education training requirements. And, she said, she’d want to know if she could still advocate for abortion access in the state.

Sereena Jivraj, a third-year medical student at Texas Christian University in Fort Worth, said that she won’t apply to programs in Alabama, Mississippi, Arkansas, and other nearby states with abortion restrictions. However, Texas is still on her list. “I’m from Texas, my family lives in Texas, and I go to school in Fort Worth, so I have made those connections,” Ms. Jivraj said.

Student advisers generally encourage ob.gyn. hopefuls to apply to 60-100 programs to ensure that they will match, Ms. Jivraj said. “How are you supposed to apply to 100 programs if many of them fall within states with high restrictions?”
 

 

 

What the future holds

Ms. Jivraj said that she’s concerned about what the future holds, especially if the law does not change in Texas. “I don’t want to go to work every day wondering if I’m going to go to jail for something that I say,” she said.

Dr. Crifase has similar fears. “I want to be able to provide the best care for my patients and that would require being able to do those procedures without having to have my first thought be: Is this legal?”

“Things feel very volatile and uncertain,” Pamela Merritt, executive director of the nonprofit Medical Students for Choice in Philadelphia, where abortion is permitted, said. “What we’re asking medical students to do right now is to envision a future in a profession, a lifetime of providing care, where the policies and procedures and standards of the profession are under attack by 26 state legislatures and the federal court system,” she said.

“I don’t think you’re going to see people as willing to take risk.” She added that if someone matches to a program and then has regrets, “You can’t easily jump from residency program to residency program.”

Dr. Levy believes that the impact of the Dobbs decision is “definitely going to be a more common question of applicants to their potential programs.”

Applicants undoubtedly are thinking about how abortion restrictions or bans might affect their own health or that of their partners or families, she said. In a 2022 survey, Dr. Levy and colleagues reported that abortion is not uncommon among physicians, with 11.5% of the 1,566 respondents who had been pregnant saying they had at least one therapeutic abortion.

Students are also considering the potential ramification of a ban on emergency contraception and laws that criminalize physicians’ provision of abortion care, Dr. Levy said. Another complicating factor is individuals’ family ties or roots in specific geographic areas, she said.

Prospective residents will also have a lot of questions about how they will receive family planning training, Dr. Levy commented. “If you’re somewhere that you can’t really provide full-spectrum reproductive health care, then the question will become: How is the program going to provide that training?”

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

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Emilee Gibson, MD, recently graduated from Southern Illinois University, Springfield, and starts her ob.gyn. residency at Vanderbilt University Medical Center in Nashville, Tenn., later this month. Abortion is permitted in Illinois but banned in Tennessee, a factor she weighed cautiously when she applied for residencies.

Dr. Gibson told this news organization that medical students, not just those interested in ob.gyn., are starting to think more about what it means to move to a state where it might be difficult to access abortion care. “Just from a personal standpoint, that’s a little scary.”

The Supreme Court’s decision to overturn Roe v. Wade abortion rights last June threatened to derail ob.gyns. in training from pursuing the specialty or locating in states that have banned or limited abortion.

Early signals from the Dobbs v. Jackson decision suggest a potential decline in ob.gyn. residents choosing abortion-restrictive states, but some industry leaders, residents, and medical students say it may be too early to judge the full impact of the ruling because most students were already far along in their decision and application for a 2023 residency position.

At this point, some ob.gyn. students are planning careers on the basis of whether they have family ties in a particular state, whether limiting their search might hurt their potential to match in a competitive specialty, and whether their faith in the family planning and abortion training being offered by a program outweighs the drawbacks of being in a state with abortion bans or restrictions.

Lucy Brown, MD, a recent graduate of Indiana University, Indianapolis, said in an interview that she’d be “very nervous” about living and practicing in abortion-restricted Indiana if she were ready to start a family.

Dr. Brown said that she mostly limited applications in the recent Match to ob.gyn. residencies in states that protected abortion rights. Though she applied to a program in her home state of Kentucky, she noted that it – along with a program in Missouri – was very low on her rank list because of their abortion restrictions.

Ultimately, Dr. Brown matched at Johns Hopkins University, Baltimore, where she will receive abortion training and assist with abortions throughout her residency. Maryland’s abortion rights status was a big attraction, she said. “Abortion is integrated into every aspect of the education.”
 

By the numbers

For students applying to residencies this summer, evaluating the state legislative landscape is a little clearer than it was 1 year ago but is still evolving. As of June 1, 56 ob.gyn. residency programs and more than 1,100 medical residents are in states with the most restrictive bans in the country (19% of all programs), according to the Bixby Center for Reproductive Health at the University of California, San Francisco.

In terms of the latest abortion laws: 14 states banned abortion, 2 states banned abortion between 6 and 12 weeks, and 9 states banned abortion between 15 and 22 weeks, whereas abortion is legal in 25 states and Washington, according to a recent analysis by the Kaiser Family Foundation.

The impact on residencies? The Association of American Medical Colleges recently reported a 2% drop in the number of U.S. MD seniors who applied to residencies and a 5% decline in the number of seniors who applied to ob.gyn. residencies. In states where abortion was banned, the number of senior applicants to ob.gyn. programs dropped by more than 10%, according to AAMC’s Research and Action Institute.

“U.S. MD seniors appear, in general, more likely to avoid states where abortions are banned,” said Atul Grover, MD, PhD, executive director of the Research and Action Institute. “That’s a big difference between states where there are abortion bans and gestational limits and states with no bans or limits; it’s almost twice as large,” Dr. Grover said in an interview. “The question is: Was it a 1-year blip or something that will be the beginning of a trend?”

In a statement to this news organization, officials from the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said that they were aware of the AAMC data but needed to further evaluate the impact of the Dobbs ruling.

A survey released at ACOG’s annual meeting in May found that 58% of third- and fourth-year medical students were unlikely to apply to a residency program in a state with abortion restrictions. Conducted after the Dobbs ruling last year, the survey found that future physicians are choosing where to attend residency according to state abortion policies, indicating that access to abortion care is changing the landscape of medical practice.

“For personal as well as professional reasons, reproductive health care access is now a key factor in residency match decisions as a result of Dobbs,” lead author Ariana Traub, MPH, said. She studies at Emory University, Atlanta, where abortion is restricted.

“Many students, including myself, struggle when trying to decide whether to stay in restricted states where the need is greatest (highest maternal mortality, infant mortality, lower number of physicians), versus going to an unrestricted state” for more comprehensive training and care, Ms. Traub said. “Regardless of this decision, Dobbs and subsequent abortion laws are making students question what matters most and how they can provide the best care.”

In another recently published survey, University of Miami fourth-year student Morgan Levy, MD, MPH, and colleagues found that 77% of students would prefer to apply to a residency program in a state that preserves access to abortion. Ensuring access to those services for themselves or a family member was a key factor, according to the paper published in the Journal of General Internal Medicine.

For Dr. Levy, who recently graduated from a school in abortion-restricted Florida and will soon apply to ob.gyn. residencies, the Dobbs decision made her more committed to becoming an ob.gyn., an interest she’s had since college, she said.

“I do not intend to limit my search,” Dr. Levy said in an interview. “In the states where there are restrictions in place, it’s really important to make sure that people are getting good care,” she said.
 

 

 

Differing perspective

Though survey and anecdotal data show that students and residents expressing hesitation about states with bans or restrictive laws, it appears that most who applied to residency programs during the 2023 Match did not shy away from those states. Almost all the open ob.gyn. residency positions were filled, according to the National Resident Matching Program.

There was no change in how U.S. MD seniors applying for 2023 residency ranked programs on the basis of whether abortion was legal, limited, or banned in the state where a program was based, Donna Lamb, DHSc, MBA, BSN, president and CEO of the NRMP, said.

“We’re seeing what we’ve seen over the past 5 years, and that is a very high fill rate, a very high rate of preference for ob.gyn., and not a heck of a lot of change,” Dr. Lamb said, noting that ob.gyn. programs continue to be very competitive. “We have more applicants than we have positions available,” she said.

In the most recent Match, there were 2,100 applicants (more than half U.S. MD seniors) for about 1,500 slots, with 1,499 initial matches, according to NRMP data. The overall fill rate was 99.7% after the Supplemental Offer and Assistance Program and Electronic Residency Applications process, NRMP reported. The results are similar to what NRMP reported as its previous all-time high year for ob.gyn. placements.

There was a dip in applicants from 2022 to 2023, even though the slots available stayed the same, but it was not markedly different from the previous 5 years, Dr. Lamb said.

“While the Dobbs decision may, indeed, have impacted applicant and application numbers to residency programs, interventions such as signaling may also contribute to the decrease in numbers of applications submitted as well,” AnnaMarie Connolly, MD, ACOG chief of education and academic affairs, and Arthur Ollendorff, MD, APOG president, said in a statement to this news organization.

For the first time in 2022, Match Day applicants were required to “signal” interest in a particular program in an effort to reduce the number of applications and cost to medical students, they noted.
 

Personal view

When it was time for Dr. Gibson to apply for ob.gyn. residencies, she wondered: Where do you apply in this landscape? But she did not limit her applications: “If I don’t apply to Indiana, Missouri, Tennessee, Wisconsin, Iowa, I’m taking a lot of really great programs off the table.” She did not want to hurt her chances for a match in a competitive specialty, she said.

“Being in Tennessee is going to give me a very different, unique opportunity to hopefully do a lot of advocacy and lobbying and hopefully have my voice heard in maybe a different way than [in Illinois],” Dr. Gibson added.

Cassie Crifase, MPH, a fourth-year student at the University of Wisconsin–Madison applying to ob.gyn. residencies in next year’s Match, said in an interview that she’s concerned about the health risk of living in a state with abortion restrictions. Wisconsin is one of those.

“My list skews toward programs that are in abortion-protected states, but I also am applying to some programs that are in restricted states.” Those states would have to help her meet the Accreditation Council for Graduate Medical Education training requirements. And, she said, she’d want to know if she could still advocate for abortion access in the state.

Sereena Jivraj, a third-year medical student at Texas Christian University in Fort Worth, said that she won’t apply to programs in Alabama, Mississippi, Arkansas, and other nearby states with abortion restrictions. However, Texas is still on her list. “I’m from Texas, my family lives in Texas, and I go to school in Fort Worth, so I have made those connections,” Ms. Jivraj said.

Student advisers generally encourage ob.gyn. hopefuls to apply to 60-100 programs to ensure that they will match, Ms. Jivraj said. “How are you supposed to apply to 100 programs if many of them fall within states with high restrictions?”
 

 

 

What the future holds

Ms. Jivraj said that she’s concerned about what the future holds, especially if the law does not change in Texas. “I don’t want to go to work every day wondering if I’m going to go to jail for something that I say,” she said.

Dr. Crifase has similar fears. “I want to be able to provide the best care for my patients and that would require being able to do those procedures without having to have my first thought be: Is this legal?”

“Things feel very volatile and uncertain,” Pamela Merritt, executive director of the nonprofit Medical Students for Choice in Philadelphia, where abortion is permitted, said. “What we’re asking medical students to do right now is to envision a future in a profession, a lifetime of providing care, where the policies and procedures and standards of the profession are under attack by 26 state legislatures and the federal court system,” she said.

“I don’t think you’re going to see people as willing to take risk.” She added that if someone matches to a program and then has regrets, “You can’t easily jump from residency program to residency program.”

Dr. Levy believes that the impact of the Dobbs decision is “definitely going to be a more common question of applicants to their potential programs.”

Applicants undoubtedly are thinking about how abortion restrictions or bans might affect their own health or that of their partners or families, she said. In a 2022 survey, Dr. Levy and colleagues reported that abortion is not uncommon among physicians, with 11.5% of the 1,566 respondents who had been pregnant saying they had at least one therapeutic abortion.

Students are also considering the potential ramification of a ban on emergency contraception and laws that criminalize physicians’ provision of abortion care, Dr. Levy said. Another complicating factor is individuals’ family ties or roots in specific geographic areas, she said.

Prospective residents will also have a lot of questions about how they will receive family planning training, Dr. Levy commented. “If you’re somewhere that you can’t really provide full-spectrum reproductive health care, then the question will become: How is the program going to provide that training?”

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

Emilee Gibson, MD, recently graduated from Southern Illinois University, Springfield, and starts her ob.gyn. residency at Vanderbilt University Medical Center in Nashville, Tenn., later this month. Abortion is permitted in Illinois but banned in Tennessee, a factor she weighed cautiously when she applied for residencies.

Dr. Gibson told this news organization that medical students, not just those interested in ob.gyn., are starting to think more about what it means to move to a state where it might be difficult to access abortion care. “Just from a personal standpoint, that’s a little scary.”

The Supreme Court’s decision to overturn Roe v. Wade abortion rights last June threatened to derail ob.gyns. in training from pursuing the specialty or locating in states that have banned or limited abortion.

Early signals from the Dobbs v. Jackson decision suggest a potential decline in ob.gyn. residents choosing abortion-restrictive states, but some industry leaders, residents, and medical students say it may be too early to judge the full impact of the ruling because most students were already far along in their decision and application for a 2023 residency position.

At this point, some ob.gyn. students are planning careers on the basis of whether they have family ties in a particular state, whether limiting their search might hurt their potential to match in a competitive specialty, and whether their faith in the family planning and abortion training being offered by a program outweighs the drawbacks of being in a state with abortion bans or restrictions.

Lucy Brown, MD, a recent graduate of Indiana University, Indianapolis, said in an interview that she’d be “very nervous” about living and practicing in abortion-restricted Indiana if she were ready to start a family.

Dr. Brown said that she mostly limited applications in the recent Match to ob.gyn. residencies in states that protected abortion rights. Though she applied to a program in her home state of Kentucky, she noted that it – along with a program in Missouri – was very low on her rank list because of their abortion restrictions.

Ultimately, Dr. Brown matched at Johns Hopkins University, Baltimore, where she will receive abortion training and assist with abortions throughout her residency. Maryland’s abortion rights status was a big attraction, she said. “Abortion is integrated into every aspect of the education.”
 

By the numbers

For students applying to residencies this summer, evaluating the state legislative landscape is a little clearer than it was 1 year ago but is still evolving. As of June 1, 56 ob.gyn. residency programs and more than 1,100 medical residents are in states with the most restrictive bans in the country (19% of all programs), according to the Bixby Center for Reproductive Health at the University of California, San Francisco.

In terms of the latest abortion laws: 14 states banned abortion, 2 states banned abortion between 6 and 12 weeks, and 9 states banned abortion between 15 and 22 weeks, whereas abortion is legal in 25 states and Washington, according to a recent analysis by the Kaiser Family Foundation.

The impact on residencies? The Association of American Medical Colleges recently reported a 2% drop in the number of U.S. MD seniors who applied to residencies and a 5% decline in the number of seniors who applied to ob.gyn. residencies. In states where abortion was banned, the number of senior applicants to ob.gyn. programs dropped by more than 10%, according to AAMC’s Research and Action Institute.

“U.S. MD seniors appear, in general, more likely to avoid states where abortions are banned,” said Atul Grover, MD, PhD, executive director of the Research and Action Institute. “That’s a big difference between states where there are abortion bans and gestational limits and states with no bans or limits; it’s almost twice as large,” Dr. Grover said in an interview. “The question is: Was it a 1-year blip or something that will be the beginning of a trend?”

In a statement to this news organization, officials from the American College of Obstetricians and Gynecologists and the Association of Professors of Gynecology and Obstetrics said that they were aware of the AAMC data but needed to further evaluate the impact of the Dobbs ruling.

A survey released at ACOG’s annual meeting in May found that 58% of third- and fourth-year medical students were unlikely to apply to a residency program in a state with abortion restrictions. Conducted after the Dobbs ruling last year, the survey found that future physicians are choosing where to attend residency according to state abortion policies, indicating that access to abortion care is changing the landscape of medical practice.

“For personal as well as professional reasons, reproductive health care access is now a key factor in residency match decisions as a result of Dobbs,” lead author Ariana Traub, MPH, said. She studies at Emory University, Atlanta, where abortion is restricted.

“Many students, including myself, struggle when trying to decide whether to stay in restricted states where the need is greatest (highest maternal mortality, infant mortality, lower number of physicians), versus going to an unrestricted state” for more comprehensive training and care, Ms. Traub said. “Regardless of this decision, Dobbs and subsequent abortion laws are making students question what matters most and how they can provide the best care.”

In another recently published survey, University of Miami fourth-year student Morgan Levy, MD, MPH, and colleagues found that 77% of students would prefer to apply to a residency program in a state that preserves access to abortion. Ensuring access to those services for themselves or a family member was a key factor, according to the paper published in the Journal of General Internal Medicine.

For Dr. Levy, who recently graduated from a school in abortion-restricted Florida and will soon apply to ob.gyn. residencies, the Dobbs decision made her more committed to becoming an ob.gyn., an interest she’s had since college, she said.

“I do not intend to limit my search,” Dr. Levy said in an interview. “In the states where there are restrictions in place, it’s really important to make sure that people are getting good care,” she said.
 

 

 

Differing perspective

Though survey and anecdotal data show that students and residents expressing hesitation about states with bans or restrictive laws, it appears that most who applied to residency programs during the 2023 Match did not shy away from those states. Almost all the open ob.gyn. residency positions were filled, according to the National Resident Matching Program.

There was no change in how U.S. MD seniors applying for 2023 residency ranked programs on the basis of whether abortion was legal, limited, or banned in the state where a program was based, Donna Lamb, DHSc, MBA, BSN, president and CEO of the NRMP, said.

“We’re seeing what we’ve seen over the past 5 years, and that is a very high fill rate, a very high rate of preference for ob.gyn., and not a heck of a lot of change,” Dr. Lamb said, noting that ob.gyn. programs continue to be very competitive. “We have more applicants than we have positions available,” she said.

In the most recent Match, there were 2,100 applicants (more than half U.S. MD seniors) for about 1,500 slots, with 1,499 initial matches, according to NRMP data. The overall fill rate was 99.7% after the Supplemental Offer and Assistance Program and Electronic Residency Applications process, NRMP reported. The results are similar to what NRMP reported as its previous all-time high year for ob.gyn. placements.

There was a dip in applicants from 2022 to 2023, even though the slots available stayed the same, but it was not markedly different from the previous 5 years, Dr. Lamb said.

“While the Dobbs decision may, indeed, have impacted applicant and application numbers to residency programs, interventions such as signaling may also contribute to the decrease in numbers of applications submitted as well,” AnnaMarie Connolly, MD, ACOG chief of education and academic affairs, and Arthur Ollendorff, MD, APOG president, said in a statement to this news organization.

For the first time in 2022, Match Day applicants were required to “signal” interest in a particular program in an effort to reduce the number of applications and cost to medical students, they noted.
 

Personal view

When it was time for Dr. Gibson to apply for ob.gyn. residencies, she wondered: Where do you apply in this landscape? But she did not limit her applications: “If I don’t apply to Indiana, Missouri, Tennessee, Wisconsin, Iowa, I’m taking a lot of really great programs off the table.” She did not want to hurt her chances for a match in a competitive specialty, she said.

“Being in Tennessee is going to give me a very different, unique opportunity to hopefully do a lot of advocacy and lobbying and hopefully have my voice heard in maybe a different way than [in Illinois],” Dr. Gibson added.

Cassie Crifase, MPH, a fourth-year student at the University of Wisconsin–Madison applying to ob.gyn. residencies in next year’s Match, said in an interview that she’s concerned about the health risk of living in a state with abortion restrictions. Wisconsin is one of those.

“My list skews toward programs that are in abortion-protected states, but I also am applying to some programs that are in restricted states.” Those states would have to help her meet the Accreditation Council for Graduate Medical Education training requirements. And, she said, she’d want to know if she could still advocate for abortion access in the state.

Sereena Jivraj, a third-year medical student at Texas Christian University in Fort Worth, said that she won’t apply to programs in Alabama, Mississippi, Arkansas, and other nearby states with abortion restrictions. However, Texas is still on her list. “I’m from Texas, my family lives in Texas, and I go to school in Fort Worth, so I have made those connections,” Ms. Jivraj said.

Student advisers generally encourage ob.gyn. hopefuls to apply to 60-100 programs to ensure that they will match, Ms. Jivraj said. “How are you supposed to apply to 100 programs if many of them fall within states with high restrictions?”
 

 

 

What the future holds

Ms. Jivraj said that she’s concerned about what the future holds, especially if the law does not change in Texas. “I don’t want to go to work every day wondering if I’m going to go to jail for something that I say,” she said.

Dr. Crifase has similar fears. “I want to be able to provide the best care for my patients and that would require being able to do those procedures without having to have my first thought be: Is this legal?”

“Things feel very volatile and uncertain,” Pamela Merritt, executive director of the nonprofit Medical Students for Choice in Philadelphia, where abortion is permitted, said. “What we’re asking medical students to do right now is to envision a future in a profession, a lifetime of providing care, where the policies and procedures and standards of the profession are under attack by 26 state legislatures and the federal court system,” she said.

“I don’t think you’re going to see people as willing to take risk.” She added that if someone matches to a program and then has regrets, “You can’t easily jump from residency program to residency program.”

Dr. Levy believes that the impact of the Dobbs decision is “definitely going to be a more common question of applicants to their potential programs.”

Applicants undoubtedly are thinking about how abortion restrictions or bans might affect their own health or that of their partners or families, she said. In a 2022 survey, Dr. Levy and colleagues reported that abortion is not uncommon among physicians, with 11.5% of the 1,566 respondents who had been pregnant saying they had at least one therapeutic abortion.

Students are also considering the potential ramification of a ban on emergency contraception and laws that criminalize physicians’ provision of abortion care, Dr. Levy said. Another complicating factor is individuals’ family ties or roots in specific geographic areas, she said.

Prospective residents will also have a lot of questions about how they will receive family planning training, Dr. Levy commented. “If you’re somewhere that you can’t really provide full-spectrum reproductive health care, then the question will become: How is the program going to provide that training?”

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

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The history and findings in this case are consistent with a diagnosis of psoriatic spondylitis.

Psoriatic spondylitis is a form of psoriatic arthritis (PsA) that affects the spine and the joints in the pelvis (axial involvement). PsA is a chronic, heterogeneous condition that affects approximately 25%-30% of patients with psoriasis, particularly those with severe psoriasis or nail or scalp involvement. It is characterized by musculoskeletal inflammation (arthritis, enthesitis, spondylitis, and dactylitis). PsA is a spondyloarthritis that can be found either in the peripheral or axial skeleton. If not treated, it may result in permanent joint damage and loss of function. 

Patients with PsA may present with nail and skin changes, peripheral arthritis, enthesitis, dactylitis, and axial spondyloarthritis (SpA), either alone or in combination. Common symptoms of axial involvement in PsA include morning back/neck stiffness that lasts longer than 30 minutes, neck or back pain that improves with activity and worsens after prolonged inactivity, and diminished mobility. PsA affects men and women equally, and typically develops when patients are between 30 and 50 years of age. As with psoriasis, PsA is associated with numerous comorbidities, such as cardiovascular disease, metabolic syndrome, obesity, diabetes, depression, uveitis, and anxiety.

The diagnosis of psoriatic spondylitis is confirmed by physical examination and imaging. Axial PsA characteristics, including sacroiliitis and spondylitis, are distinguished by the development of syndesmophytes (ie, ossification of the annulus fibrosus). Useful imaging tools for evaluating patients with PsA include plain radiography, CT, ultrasound, and MRI. Although MRI and ultrasound may be more sensitive than plain radiography for detecting early joint inflammation and damage and axial changes, including sacroiliitis, they are not mandatory for a diagnosis of PsA to be made.

International guidelines have been developed by the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the European Alliance of Associations for Rheumatology (EULAR), and the Assessment of Spondyloarthritis International Society to guide the treatment of axial PsA. The goals of treatment include minimizing pain, stiffness, and fatigue; improving and preserving spinal flexibility and posture; improving functional capacity; and maintaining the ability to work, with a target of remission or minimal/low disease activity.

Treatment options for symptomatic relief include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and sacroiliac joint injections with glucocorticoids for mild disease; long-term treatment with systemic glucocorticoids is not recommended. If patients remain symptomatic or have erosive disease or other indications of high disease activity, guidelines recommend initiation of a tumor necrosis factor (TNF) inhibitor (eg, adalimumab, etanercept, infliximab, golimumab, certolizumab pegol). Disease-modifying antirheumatic drugs (eg, methotrexate) are not routinely prescribed for patients with axial disease because they have not been shown to be effective. In patients with significant skin involvement, treatment with interleukin-17A inhibitors may be preferred to TNF inhibitors. 

If patients have an inadequate response to a first trial of a TNF inhibitor, guidelines recommend trying a second TNF inhibitor before switching to a different class of biologic. For patients who do not respond to TNF inhibitors, a Janus kinase inhibitor (tofacitinib) may be considered. Additionally, nonpharmacologic therapies (eg, exercise, physical therapy, massage therapy, occupational therapy, acupuncture) are recommended for all patients with active PsA.

Herbert S. Diamond, MD, Professor of Medicine (retired), Temple University School of Medicine, University of Pittsburgh; Chairman, Department of Medicine Emeritus, Western Pennsylvania Hospital, Pittsburgh, PA.

Herbert S. Diamond, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

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The history and findings in this case are consistent with a diagnosis of psoriatic spondylitis.

Psoriatic spondylitis is a form of psoriatic arthritis (PsA) that affects the spine and the joints in the pelvis (axial involvement). PsA is a chronic, heterogeneous condition that affects approximately 25%-30% of patients with psoriasis, particularly those with severe psoriasis or nail or scalp involvement. It is characterized by musculoskeletal inflammation (arthritis, enthesitis, spondylitis, and dactylitis). PsA is a spondyloarthritis that can be found either in the peripheral or axial skeleton. If not treated, it may result in permanent joint damage and loss of function. 

Patients with PsA may present with nail and skin changes, peripheral arthritis, enthesitis, dactylitis, and axial spondyloarthritis (SpA), either alone or in combination. Common symptoms of axial involvement in PsA include morning back/neck stiffness that lasts longer than 30 minutes, neck or back pain that improves with activity and worsens after prolonged inactivity, and diminished mobility. PsA affects men and women equally, and typically develops when patients are between 30 and 50 years of age. As with psoriasis, PsA is associated with numerous comorbidities, such as cardiovascular disease, metabolic syndrome, obesity, diabetes, depression, uveitis, and anxiety.

The diagnosis of psoriatic spondylitis is confirmed by physical examination and imaging. Axial PsA characteristics, including sacroiliitis and spondylitis, are distinguished by the development of syndesmophytes (ie, ossification of the annulus fibrosus). Useful imaging tools for evaluating patients with PsA include plain radiography, CT, ultrasound, and MRI. Although MRI and ultrasound may be more sensitive than plain radiography for detecting early joint inflammation and damage and axial changes, including sacroiliitis, they are not mandatory for a diagnosis of PsA to be made.

International guidelines have been developed by the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the European Alliance of Associations for Rheumatology (EULAR), and the Assessment of Spondyloarthritis International Society to guide the treatment of axial PsA. The goals of treatment include minimizing pain, stiffness, and fatigue; improving and preserving spinal flexibility and posture; improving functional capacity; and maintaining the ability to work, with a target of remission or minimal/low disease activity.

Treatment options for symptomatic relief include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and sacroiliac joint injections with glucocorticoids for mild disease; long-term treatment with systemic glucocorticoids is not recommended. If patients remain symptomatic or have erosive disease or other indications of high disease activity, guidelines recommend initiation of a tumor necrosis factor (TNF) inhibitor (eg, adalimumab, etanercept, infliximab, golimumab, certolizumab pegol). Disease-modifying antirheumatic drugs (eg, methotrexate) are not routinely prescribed for patients with axial disease because they have not been shown to be effective. In patients with significant skin involvement, treatment with interleukin-17A inhibitors may be preferred to TNF inhibitors. 

If patients have an inadequate response to a first trial of a TNF inhibitor, guidelines recommend trying a second TNF inhibitor before switching to a different class of biologic. For patients who do not respond to TNF inhibitors, a Janus kinase inhibitor (tofacitinib) may be considered. Additionally, nonpharmacologic therapies (eg, exercise, physical therapy, massage therapy, occupational therapy, acupuncture) are recommended for all patients with active PsA.

Herbert S. Diamond, MD, Professor of Medicine (retired), Temple University School of Medicine, University of Pittsburgh; Chairman, Department of Medicine Emeritus, Western Pennsylvania Hospital, Pittsburgh, PA.

Herbert S. Diamond, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

The history and findings in this case are consistent with a diagnosis of psoriatic spondylitis.

Psoriatic spondylitis is a form of psoriatic arthritis (PsA) that affects the spine and the joints in the pelvis (axial involvement). PsA is a chronic, heterogeneous condition that affects approximately 25%-30% of patients with psoriasis, particularly those with severe psoriasis or nail or scalp involvement. It is characterized by musculoskeletal inflammation (arthritis, enthesitis, spondylitis, and dactylitis). PsA is a spondyloarthritis that can be found either in the peripheral or axial skeleton. If not treated, it may result in permanent joint damage and loss of function. 

Patients with PsA may present with nail and skin changes, peripheral arthritis, enthesitis, dactylitis, and axial spondyloarthritis (SpA), either alone or in combination. Common symptoms of axial involvement in PsA include morning back/neck stiffness that lasts longer than 30 minutes, neck or back pain that improves with activity and worsens after prolonged inactivity, and diminished mobility. PsA affects men and women equally, and typically develops when patients are between 30 and 50 years of age. As with psoriasis, PsA is associated with numerous comorbidities, such as cardiovascular disease, metabolic syndrome, obesity, diabetes, depression, uveitis, and anxiety.

The diagnosis of psoriatic spondylitis is confirmed by physical examination and imaging. Axial PsA characteristics, including sacroiliitis and spondylitis, are distinguished by the development of syndesmophytes (ie, ossification of the annulus fibrosus). Useful imaging tools for evaluating patients with PsA include plain radiography, CT, ultrasound, and MRI. Although MRI and ultrasound may be more sensitive than plain radiography for detecting early joint inflammation and damage and axial changes, including sacroiliitis, they are not mandatory for a diagnosis of PsA to be made.

International guidelines have been developed by the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the European Alliance of Associations for Rheumatology (EULAR), and the Assessment of Spondyloarthritis International Society to guide the treatment of axial PsA. The goals of treatment include minimizing pain, stiffness, and fatigue; improving and preserving spinal flexibility and posture; improving functional capacity; and maintaining the ability to work, with a target of remission or minimal/low disease activity.

Treatment options for symptomatic relief include nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, and sacroiliac joint injections with glucocorticoids for mild disease; long-term treatment with systemic glucocorticoids is not recommended. If patients remain symptomatic or have erosive disease or other indications of high disease activity, guidelines recommend initiation of a tumor necrosis factor (TNF) inhibitor (eg, adalimumab, etanercept, infliximab, golimumab, certolizumab pegol). Disease-modifying antirheumatic drugs (eg, methotrexate) are not routinely prescribed for patients with axial disease because they have not been shown to be effective. In patients with significant skin involvement, treatment with interleukin-17A inhibitors may be preferred to TNF inhibitors. 

If patients have an inadequate response to a first trial of a TNF inhibitor, guidelines recommend trying a second TNF inhibitor before switching to a different class of biologic. For patients who do not respond to TNF inhibitors, a Janus kinase inhibitor (tofacitinib) may be considered. Additionally, nonpharmacologic therapies (eg, exercise, physical therapy, massage therapy, occupational therapy, acupuncture) are recommended for all patients with active PsA.

Herbert S. Diamond, MD, Professor of Medicine (retired), Temple University School of Medicine, University of Pittsburgh; Chairman, Department of Medicine Emeritus, Western Pennsylvania Hospital, Pittsburgh, PA.

Herbert S. Diamond, MD, has disclosed no relevant financial relationships.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

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angkhan/iStock/Getty Images Plus

 

 

 

 

 

 

 

 

 

A 41-year-old man with a 5-year history of moderate to severe scalp psoriasis presents with complaints of intermittent pain and stiffness in his left hip and lower back of approximately 6 months' duration. The patient states that his back pain has been severe enough to wake him up on several occasions. Treatment with over-the-counter ibuprofen is moderately effective at relieving his pain. He also reports morning back stiffness that improves with motion, usually within an hour of awakening. The patient reports no fever, pain, swelling, or worsening of his scalp psoriasis. He is not aware of any injury or other triggering factor for his back pain. He takes an over-the-counter multivitamin daily and treats his scalp psoriasis with fluocinolone acetonide 0.01% oil. The patient is 5 ft 9 in and weighs 176 lb (BMI 26).

Physical examination reveals tenderness in the lumbar spine and associated decreased range of motion, as well as psoriatic plaques on the scalp. Vital signs are within normal ranges. Pertinent laboratory findings include erythrocyte sedimentation rate of 19 mm/h and C-reactive protein of 10 mg/L. Rheumatoid factor, antinuclear antibody, and anti-cyclic citrullinated peptide antibody were negative. Radiographic findings include sacroiliitis and bulky nonmarginal syndesmophytes. 

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Self-talk overhaul may help patients achieve weight loss

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Fri, 06/16/2023 - 11:50

It’s common knowledge that the recommended first-line treatment for obesity is behavioral or “lifestyle” intervention, with the goal of losing a modest amount of weight to gain significant health benefits. Unfortunately, when pursuing weight loss, patients often think they need to beat themselves up to stay motivated. I’ve heard patients call themselves “weak,” saying they need to “stop being lazy” and gain some self-control in order to be less of a “failure.” They label their bodies as “disgusting” and themselves as “worthless,” all because of their weight.

Some patients may worry that if they are kind to themselves or “too accepting” of their bodies, they’ll lose motivation to stick with their health behavior goals. In many people’s minds, weight management and body- and self-acceptance are mutually exclusive.

What if patients didn’t have to choose between the two?
That’s a question that my colleagues and I have explored in recent research that attempts to reduce weight stigma as part of standard weight-related care.
 

Misguided societal view drives blame game

This tendency for people to blame and disparage themselves for their weight is largely driven by the misguided societal view of body weight as an issue of personal responsibility. We’re constantly exposed to messages telling us that there’s a narrow range of acceptable body weights and sizes, and that if we have enough willpower and discipline to eat healthily and exercise, then we should be able to control our weight. These messages are prevalent in the news and in social media, but often they are communicated in health care settings too. Narratives of this kind usually ignore the complex environmental and biological factors that contribute to body size and shape, instead attributing high body weight to laziness and moral failings.

Such messages exemplify weight bias and stigma, or the negative attitudes toward and mistreatment of individuals with a high body weight. Given society’s harsh judgment of people with larger bodies, it’s no surprise that many individuals internalize these beliefs and stigmatize themselves for their weight. This internalized or self-directed stigma is known to be harmful to mental and physical health.

Contrary to beliefs that negative self-talk and self-blame can be motivators to improve health, we know that high levels of weight self-stigma are linked to unhealthy eating behaviors and less engagement in physical activity, among other poor health outcomes. Thus, ironically, internalizing weight stigma actually undermines efforts to lose weight and maintain weight loss, rather than motivating healthy behavior change.
 

Combating internalized weight stigma

How do we combat these negative weight messages in our culture and reduce, or ideally prevent, internalization of judgment and blame? Fundamental changes in policies, health care practices, and public attitudes are needed to eradicate weight stigma. While such initiatives are underway, there are many individuals who have already experienced and internalized weight stigma and need support now. Interventions such as peer support and psychological counseling may be helpful for challenging negative, internalized beliefs about weight; learning to cope with exposure to weight stigma without internalizing it; increasing self-acceptance and self-compassion; and feeling empowered to fight back against weight bias and stigma.

In our latest study, my colleagues and I tested the long-term effects of including a group intervention to address weight stigma in a standard behavioral weight management program. More than 100 adults with obesity who had experienced and internalized weight stigma were recruited for this clinical trial, which randomly assigned participants to receive either the Weight Bias Internalization and Stigma (Weight BIAS) program combined with standard behavioral weight loss treatment, or standard weight loss treatment alone.

The Weight BIAS program adapted evidence-based psychotherapy techniques to target weight self-stigma, while also providing peer support in a group treatment format. Specific topics included challenging myths and stereotypes about weight; identifying and changing negative thought patterns related to weight and how they affect emotions and behaviors; and responding to experiences of weight stigma.

For example, to challenge negative thoughts (for example, that they were a “failure” because of their weight), patients worked together to examine all of the evidence that proved these beliefs were not true, and came up with ideas for how to revise these thoughts to be less judgmental and more fair and accurate.

Other topics focused on building confidence, increasing body- and self-acceptance, and advocating for themselves and others who are mistreated because of their weight. Many patients shared examples of stigmatizing experiences in health care settings and discussed what they could say or do when facing judgment or discrimination from health care providers, as well as the importance of finding health care providers who treated them with respect. Group discussions also tied in information relevant to health behavior goals, such as overcoming self-consciousness about weight to enjoy physical activity.

Participants were offered weekly group meetings for 20 weeks, followed by a year of less frequent meetings. At the study’s end, participants in the group that received weight loss treatment with the Weight BIAS program on average lost about 7% of their starting weight, compared with an average weight loss of about 5% in the group that received weight loss treatment alone. Weight losses of these magnitudes are known to have meaningful health benefits. Results from our study showed comparable improvements in most outcomes across groups, with some added benefit of the Weight BIAS program for certain psychological and behavioral outcomes. These findings challenge the notion that reducing weight stigma and promoting body acceptance will undermine motivation to engage in healthy behaviors and lose weight. We found no such effect.
 

What did participants say?

When asked questions such as how much they liked the program, what they learned, and how they used the new skills and changed their self-perceptions, participants who received the Weight BIAS program gave higher ratings than those who received only the weight loss treatment. Positive feedback from free-response questions indicated that many participants identified social support as their favorite aspect of the program. Others highlighted how the program helped them to gain “the ability to think differently about myself and other people” and “an understanding that weight really is separate from the person.” They also described how they brought together the goals of weight loss and body and self-acceptance, saying, “I am more accepting of me and at the same time more dedicated to obtaining a healthier weight,” and “It’s okay to be happy the way I am and still want to change.”

Participants who didn’t receive the Weight BIAS program also shared positive feedback, writing that their favorite part of the program was “being part of such a supportive group of people who can relate to the things that I think and feel” and that they learned “how not to be so hard on myself.” This might suggest that even without an intervention specifically for weight stigma, providing respectful, compassionate care and peer support may help patients to feel less alone and to be kinder to themselves.

Our study results suggest that reducing negative self-talk and internalized beliefs about weight certainly won’t undermine treatment outcomes and may have some benefits beyond standard weight loss treatment. At the same time, we also all need to do our part to change how society views and treats people with larger bodies and prevent the harms of experiencing and internalizing weight stigma.

Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number K23HL140176. The content is solely the responsibility of the author and does not necessarily reflect the official views of the National Institutes of Health.
 

Dr. Pearl is assistant professor, clinical and health psychology, University of Florida, Gainesville. She has disclosed no relevant financial relationships.

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

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It’s common knowledge that the recommended first-line treatment for obesity is behavioral or “lifestyle” intervention, with the goal of losing a modest amount of weight to gain significant health benefits. Unfortunately, when pursuing weight loss, patients often think they need to beat themselves up to stay motivated. I’ve heard patients call themselves “weak,” saying they need to “stop being lazy” and gain some self-control in order to be less of a “failure.” They label their bodies as “disgusting” and themselves as “worthless,” all because of their weight.

Some patients may worry that if they are kind to themselves or “too accepting” of their bodies, they’ll lose motivation to stick with their health behavior goals. In many people’s minds, weight management and body- and self-acceptance are mutually exclusive.

What if patients didn’t have to choose between the two?
That’s a question that my colleagues and I have explored in recent research that attempts to reduce weight stigma as part of standard weight-related care.
 

Misguided societal view drives blame game

This tendency for people to blame and disparage themselves for their weight is largely driven by the misguided societal view of body weight as an issue of personal responsibility. We’re constantly exposed to messages telling us that there’s a narrow range of acceptable body weights and sizes, and that if we have enough willpower and discipline to eat healthily and exercise, then we should be able to control our weight. These messages are prevalent in the news and in social media, but often they are communicated in health care settings too. Narratives of this kind usually ignore the complex environmental and biological factors that contribute to body size and shape, instead attributing high body weight to laziness and moral failings.

Such messages exemplify weight bias and stigma, or the negative attitudes toward and mistreatment of individuals with a high body weight. Given society’s harsh judgment of people with larger bodies, it’s no surprise that many individuals internalize these beliefs and stigmatize themselves for their weight. This internalized or self-directed stigma is known to be harmful to mental and physical health.

Contrary to beliefs that negative self-talk and self-blame can be motivators to improve health, we know that high levels of weight self-stigma are linked to unhealthy eating behaviors and less engagement in physical activity, among other poor health outcomes. Thus, ironically, internalizing weight stigma actually undermines efforts to lose weight and maintain weight loss, rather than motivating healthy behavior change.
 

Combating internalized weight stigma

How do we combat these negative weight messages in our culture and reduce, or ideally prevent, internalization of judgment and blame? Fundamental changes in policies, health care practices, and public attitudes are needed to eradicate weight stigma. While such initiatives are underway, there are many individuals who have already experienced and internalized weight stigma and need support now. Interventions such as peer support and psychological counseling may be helpful for challenging negative, internalized beliefs about weight; learning to cope with exposure to weight stigma without internalizing it; increasing self-acceptance and self-compassion; and feeling empowered to fight back against weight bias and stigma.

In our latest study, my colleagues and I tested the long-term effects of including a group intervention to address weight stigma in a standard behavioral weight management program. More than 100 adults with obesity who had experienced and internalized weight stigma were recruited for this clinical trial, which randomly assigned participants to receive either the Weight Bias Internalization and Stigma (Weight BIAS) program combined with standard behavioral weight loss treatment, or standard weight loss treatment alone.

The Weight BIAS program adapted evidence-based psychotherapy techniques to target weight self-stigma, while also providing peer support in a group treatment format. Specific topics included challenging myths and stereotypes about weight; identifying and changing negative thought patterns related to weight and how they affect emotions and behaviors; and responding to experiences of weight stigma.

For example, to challenge negative thoughts (for example, that they were a “failure” because of their weight), patients worked together to examine all of the evidence that proved these beliefs were not true, and came up with ideas for how to revise these thoughts to be less judgmental and more fair and accurate.

Other topics focused on building confidence, increasing body- and self-acceptance, and advocating for themselves and others who are mistreated because of their weight. Many patients shared examples of stigmatizing experiences in health care settings and discussed what they could say or do when facing judgment or discrimination from health care providers, as well as the importance of finding health care providers who treated them with respect. Group discussions also tied in information relevant to health behavior goals, such as overcoming self-consciousness about weight to enjoy physical activity.

Participants were offered weekly group meetings for 20 weeks, followed by a year of less frequent meetings. At the study’s end, participants in the group that received weight loss treatment with the Weight BIAS program on average lost about 7% of their starting weight, compared with an average weight loss of about 5% in the group that received weight loss treatment alone. Weight losses of these magnitudes are known to have meaningful health benefits. Results from our study showed comparable improvements in most outcomes across groups, with some added benefit of the Weight BIAS program for certain psychological and behavioral outcomes. These findings challenge the notion that reducing weight stigma and promoting body acceptance will undermine motivation to engage in healthy behaviors and lose weight. We found no such effect.
 

What did participants say?

When asked questions such as how much they liked the program, what they learned, and how they used the new skills and changed their self-perceptions, participants who received the Weight BIAS program gave higher ratings than those who received only the weight loss treatment. Positive feedback from free-response questions indicated that many participants identified social support as their favorite aspect of the program. Others highlighted how the program helped them to gain “the ability to think differently about myself and other people” and “an understanding that weight really is separate from the person.” They also described how they brought together the goals of weight loss and body and self-acceptance, saying, “I am more accepting of me and at the same time more dedicated to obtaining a healthier weight,” and “It’s okay to be happy the way I am and still want to change.”

Participants who didn’t receive the Weight BIAS program also shared positive feedback, writing that their favorite part of the program was “being part of such a supportive group of people who can relate to the things that I think and feel” and that they learned “how not to be so hard on myself.” This might suggest that even without an intervention specifically for weight stigma, providing respectful, compassionate care and peer support may help patients to feel less alone and to be kinder to themselves.

Our study results suggest that reducing negative self-talk and internalized beliefs about weight certainly won’t undermine treatment outcomes and may have some benefits beyond standard weight loss treatment. At the same time, we also all need to do our part to change how society views and treats people with larger bodies and prevent the harms of experiencing and internalizing weight stigma.

Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number K23HL140176. The content is solely the responsibility of the author and does not necessarily reflect the official views of the National Institutes of Health.
 

Dr. Pearl is assistant professor, clinical and health psychology, University of Florida, Gainesville. She has disclosed no relevant financial relationships.

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

It’s common knowledge that the recommended first-line treatment for obesity is behavioral or “lifestyle” intervention, with the goal of losing a modest amount of weight to gain significant health benefits. Unfortunately, when pursuing weight loss, patients often think they need to beat themselves up to stay motivated. I’ve heard patients call themselves “weak,” saying they need to “stop being lazy” and gain some self-control in order to be less of a “failure.” They label their bodies as “disgusting” and themselves as “worthless,” all because of their weight.

Some patients may worry that if they are kind to themselves or “too accepting” of their bodies, they’ll lose motivation to stick with their health behavior goals. In many people’s minds, weight management and body- and self-acceptance are mutually exclusive.

What if patients didn’t have to choose between the two?
That’s a question that my colleagues and I have explored in recent research that attempts to reduce weight stigma as part of standard weight-related care.
 

Misguided societal view drives blame game

This tendency for people to blame and disparage themselves for their weight is largely driven by the misguided societal view of body weight as an issue of personal responsibility. We’re constantly exposed to messages telling us that there’s a narrow range of acceptable body weights and sizes, and that if we have enough willpower and discipline to eat healthily and exercise, then we should be able to control our weight. These messages are prevalent in the news and in social media, but often they are communicated in health care settings too. Narratives of this kind usually ignore the complex environmental and biological factors that contribute to body size and shape, instead attributing high body weight to laziness and moral failings.

Such messages exemplify weight bias and stigma, or the negative attitudes toward and mistreatment of individuals with a high body weight. Given society’s harsh judgment of people with larger bodies, it’s no surprise that many individuals internalize these beliefs and stigmatize themselves for their weight. This internalized or self-directed stigma is known to be harmful to mental and physical health.

Contrary to beliefs that negative self-talk and self-blame can be motivators to improve health, we know that high levels of weight self-stigma are linked to unhealthy eating behaviors and less engagement in physical activity, among other poor health outcomes. Thus, ironically, internalizing weight stigma actually undermines efforts to lose weight and maintain weight loss, rather than motivating healthy behavior change.
 

Combating internalized weight stigma

How do we combat these negative weight messages in our culture and reduce, or ideally prevent, internalization of judgment and blame? Fundamental changes in policies, health care practices, and public attitudes are needed to eradicate weight stigma. While such initiatives are underway, there are many individuals who have already experienced and internalized weight stigma and need support now. Interventions such as peer support and psychological counseling may be helpful for challenging negative, internalized beliefs about weight; learning to cope with exposure to weight stigma without internalizing it; increasing self-acceptance and self-compassion; and feeling empowered to fight back against weight bias and stigma.

In our latest study, my colleagues and I tested the long-term effects of including a group intervention to address weight stigma in a standard behavioral weight management program. More than 100 adults with obesity who had experienced and internalized weight stigma were recruited for this clinical trial, which randomly assigned participants to receive either the Weight Bias Internalization and Stigma (Weight BIAS) program combined with standard behavioral weight loss treatment, or standard weight loss treatment alone.

The Weight BIAS program adapted evidence-based psychotherapy techniques to target weight self-stigma, while also providing peer support in a group treatment format. Specific topics included challenging myths and stereotypes about weight; identifying and changing negative thought patterns related to weight and how they affect emotions and behaviors; and responding to experiences of weight stigma.

For example, to challenge negative thoughts (for example, that they were a “failure” because of their weight), patients worked together to examine all of the evidence that proved these beliefs were not true, and came up with ideas for how to revise these thoughts to be less judgmental and more fair and accurate.

Other topics focused on building confidence, increasing body- and self-acceptance, and advocating for themselves and others who are mistreated because of their weight. Many patients shared examples of stigmatizing experiences in health care settings and discussed what they could say or do when facing judgment or discrimination from health care providers, as well as the importance of finding health care providers who treated them with respect. Group discussions also tied in information relevant to health behavior goals, such as overcoming self-consciousness about weight to enjoy physical activity.

Participants were offered weekly group meetings for 20 weeks, followed by a year of less frequent meetings. At the study’s end, participants in the group that received weight loss treatment with the Weight BIAS program on average lost about 7% of their starting weight, compared with an average weight loss of about 5% in the group that received weight loss treatment alone. Weight losses of these magnitudes are known to have meaningful health benefits. Results from our study showed comparable improvements in most outcomes across groups, with some added benefit of the Weight BIAS program for certain psychological and behavioral outcomes. These findings challenge the notion that reducing weight stigma and promoting body acceptance will undermine motivation to engage in healthy behaviors and lose weight. We found no such effect.
 

What did participants say?

When asked questions such as how much they liked the program, what they learned, and how they used the new skills and changed their self-perceptions, participants who received the Weight BIAS program gave higher ratings than those who received only the weight loss treatment. Positive feedback from free-response questions indicated that many participants identified social support as their favorite aspect of the program. Others highlighted how the program helped them to gain “the ability to think differently about myself and other people” and “an understanding that weight really is separate from the person.” They also described how they brought together the goals of weight loss and body and self-acceptance, saying, “I am more accepting of me and at the same time more dedicated to obtaining a healthier weight,” and “It’s okay to be happy the way I am and still want to change.”

Participants who didn’t receive the Weight BIAS program also shared positive feedback, writing that their favorite part of the program was “being part of such a supportive group of people who can relate to the things that I think and feel” and that they learned “how not to be so hard on myself.” This might suggest that even without an intervention specifically for weight stigma, providing respectful, compassionate care and peer support may help patients to feel less alone and to be kinder to themselves.

Our study results suggest that reducing negative self-talk and internalized beliefs about weight certainly won’t undermine treatment outcomes and may have some benefits beyond standard weight loss treatment. At the same time, we also all need to do our part to change how society views and treats people with larger bodies and prevent the harms of experiencing and internalizing weight stigma.

Research reported in this publication was supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award number K23HL140176. The content is solely the responsibility of the author and does not necessarily reflect the official views of the National Institutes of Health.
 

Dr. Pearl is assistant professor, clinical and health psychology, University of Florida, Gainesville. She has disclosed no relevant financial relationships.

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

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Multiple sclerosis has a misdiagnosis problem

Article Type
Changed
Mon, 06/19/2023 - 12:44

In the ongoing absence of a reliable biomarker for multiple sclerosis (MS), misdiagnosis is a common and persistent problem that potentially puts patients at prolonged and unnecessary risk. Experts warn that false-negative diagnoses cause treatment delays, while false-positive diagnoses run the risk for potential harm from needless treatment.

“MS has a misdiagnosis problem,” said Patricia Coyle, MD, professor of neurology and vice chair (academic affairs), department of neurology, Stony Brook (N.Y.) University, in presenting on the issue at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“We currently lack a diagnostic biomarker test, yet diagnosis is key. If you get it wrong – that really can be a problem,” Dr. Coyle said. Recent research indicates that MS misdiagnosis is a widespread problem, she added.

For instance, one research paper reported that nearly 20% of patients were misdiagnosed with MS and that more than 50% carried the misdiagnosis for at least 3 years, while 5% were misdiagnosed for 20 years or more.

The misdiagnosis problem is also reflected at large MS referral centers, where 30%-67% of patients turn out not to have the disease, Dr. Coyle noted.

study from Argentina further highlights some of the key characteristics of misdiagnosis. In this study, examination of a cohort of 572 patients diagnosed with MS revealed that 16% were incorrectly diagnosed with MS and that women were at an 83% greater risk for misdiagnosis than men. Furthermore, the study showed that MS misdiagnosis increased by 8% per year of older age. The most frequent confirmed diagnoses among those who had been initially misdiagnosed as having MS were cerebrovascular disease, radiologically isolated syndrome, and headache.

The majority (83%) of patients incorrectly diagnosed with MS had an atypical presentation that did not indicate demyelination, 70% had an atypical brain magnetic resonance imaging, and 61% received a prescription for a disease-modifying treatment (DMT), despite not having confirmed MS.
 

The dangers of misdiagnosis

Misdiagnosis and incorrect treatment can be particularly dangerous if patients are diagnosed with MS when, in fact, they have neuromyelitis optica spectrum disorder (NMOSD), commonly mistaken for MS, Dr. Coyle noted.

“Several MS DMTs make NMOSD worse. You are also basically giving an unnecessary and inappropriate drug with potential side effects to the misdiagnosed patient,” she said.

There have been some advances in MS diagnosis on MRI. However, there are many caveats, Dr. Coyle noted.

For instance, leptomeningeal enhancement has been considered as an MS diagnostic indicator, but it is not unique to MS, Dr. Coyle noted. In addition, subpial demyelination is MS specific, but it is hard to see and is often missed, she added.

Central vein sign has received significant attention as an important MRI marker for MS, but, Dr. Coyle said, it is “not ready for prime time. It’s somewhat tedious and you need to use special protocols to identify it,” she said.

In the future, artificial intelligence and deep learning may be key to improving some of these technologies, Dr. Coyle noted.
 

Best hope for an accurate diagnosis

In the meantime, Dr. Coyle said she believes spinal fluid evaluation offers the best chance for a reliable MS diagnosis and is her preference. “I personally find spinal fluid to be extremely helpful to support MS diagnosis. Spinal fluid oligoclonal bands are positive in the vast majority of people with MS, and it is an independent finding from MRI to support an MS diagnosis. Added to MRI, it makes you much more comfortable,” she said.

Dr. Coyle said that a comprehensive workup should include:

  • A thorough neurologic history and exam.
  • MRI of the brain and spinal cord ensuring use of the MS protocol, and personally reading the studies with a neuroradiologist.
  • Adding spinal fluid evaluation, especially in any atypical cases.
  • Ruling out myelin oligodendrocyte glycoprotein antibody disease and NMOSD, diseases that mimic relapsing MS, via blood IgG to aquaporin 4.

“You want to be as certain as possible. Everything starts with a thorough workup,” Dr. Coyle said.

Dr. Coyle’s disclosures include consulting, nonbranded speaker fees, and/or research support with Actelion, Alkermes, Accordant, Biogen, Bristol Myers Squibb, Celgene, CorEvitas LLC, GlaxoSmithKline, Genentech/Roche, Horizon Therapeutics, Janssen, MedDay, Labcorp, Eli Lilly, Mylan, NINDS, Novartis, Sanofi Genzyme, and TG Therapeutics.

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

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In the ongoing absence of a reliable biomarker for multiple sclerosis (MS), misdiagnosis is a common and persistent problem that potentially puts patients at prolonged and unnecessary risk. Experts warn that false-negative diagnoses cause treatment delays, while false-positive diagnoses run the risk for potential harm from needless treatment.

“MS has a misdiagnosis problem,” said Patricia Coyle, MD, professor of neurology and vice chair (academic affairs), department of neurology, Stony Brook (N.Y.) University, in presenting on the issue at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“We currently lack a diagnostic biomarker test, yet diagnosis is key. If you get it wrong – that really can be a problem,” Dr. Coyle said. Recent research indicates that MS misdiagnosis is a widespread problem, she added.

For instance, one research paper reported that nearly 20% of patients were misdiagnosed with MS and that more than 50% carried the misdiagnosis for at least 3 years, while 5% were misdiagnosed for 20 years or more.

The misdiagnosis problem is also reflected at large MS referral centers, where 30%-67% of patients turn out not to have the disease, Dr. Coyle noted.

study from Argentina further highlights some of the key characteristics of misdiagnosis. In this study, examination of a cohort of 572 patients diagnosed with MS revealed that 16% were incorrectly diagnosed with MS and that women were at an 83% greater risk for misdiagnosis than men. Furthermore, the study showed that MS misdiagnosis increased by 8% per year of older age. The most frequent confirmed diagnoses among those who had been initially misdiagnosed as having MS were cerebrovascular disease, radiologically isolated syndrome, and headache.

The majority (83%) of patients incorrectly diagnosed with MS had an atypical presentation that did not indicate demyelination, 70% had an atypical brain magnetic resonance imaging, and 61% received a prescription for a disease-modifying treatment (DMT), despite not having confirmed MS.
 

The dangers of misdiagnosis

Misdiagnosis and incorrect treatment can be particularly dangerous if patients are diagnosed with MS when, in fact, they have neuromyelitis optica spectrum disorder (NMOSD), commonly mistaken for MS, Dr. Coyle noted.

“Several MS DMTs make NMOSD worse. You are also basically giving an unnecessary and inappropriate drug with potential side effects to the misdiagnosed patient,” she said.

There have been some advances in MS diagnosis on MRI. However, there are many caveats, Dr. Coyle noted.

For instance, leptomeningeal enhancement has been considered as an MS diagnostic indicator, but it is not unique to MS, Dr. Coyle noted. In addition, subpial demyelination is MS specific, but it is hard to see and is often missed, she added.

Central vein sign has received significant attention as an important MRI marker for MS, but, Dr. Coyle said, it is “not ready for prime time. It’s somewhat tedious and you need to use special protocols to identify it,” she said.

In the future, artificial intelligence and deep learning may be key to improving some of these technologies, Dr. Coyle noted.
 

Best hope for an accurate diagnosis

In the meantime, Dr. Coyle said she believes spinal fluid evaluation offers the best chance for a reliable MS diagnosis and is her preference. “I personally find spinal fluid to be extremely helpful to support MS diagnosis. Spinal fluid oligoclonal bands are positive in the vast majority of people with MS, and it is an independent finding from MRI to support an MS diagnosis. Added to MRI, it makes you much more comfortable,” she said.

Dr. Coyle said that a comprehensive workup should include:

  • A thorough neurologic history and exam.
  • MRI of the brain and spinal cord ensuring use of the MS protocol, and personally reading the studies with a neuroradiologist.
  • Adding spinal fluid evaluation, especially in any atypical cases.
  • Ruling out myelin oligodendrocyte glycoprotein antibody disease and NMOSD, diseases that mimic relapsing MS, via blood IgG to aquaporin 4.

“You want to be as certain as possible. Everything starts with a thorough workup,” Dr. Coyle said.

Dr. Coyle’s disclosures include consulting, nonbranded speaker fees, and/or research support with Actelion, Alkermes, Accordant, Biogen, Bristol Myers Squibb, Celgene, CorEvitas LLC, GlaxoSmithKline, Genentech/Roche, Horizon Therapeutics, Janssen, MedDay, Labcorp, Eli Lilly, Mylan, NINDS, Novartis, Sanofi Genzyme, and TG Therapeutics.

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

In the ongoing absence of a reliable biomarker for multiple sclerosis (MS), misdiagnosis is a common and persistent problem that potentially puts patients at prolonged and unnecessary risk. Experts warn that false-negative diagnoses cause treatment delays, while false-positive diagnoses run the risk for potential harm from needless treatment.

“MS has a misdiagnosis problem,” said Patricia Coyle, MD, professor of neurology and vice chair (academic affairs), department of neurology, Stony Brook (N.Y.) University, in presenting on the issue at the annual meeting of the Consortium of Multiple Sclerosis Centers.

“We currently lack a diagnostic biomarker test, yet diagnosis is key. If you get it wrong – that really can be a problem,” Dr. Coyle said. Recent research indicates that MS misdiagnosis is a widespread problem, she added.

For instance, one research paper reported that nearly 20% of patients were misdiagnosed with MS and that more than 50% carried the misdiagnosis for at least 3 years, while 5% were misdiagnosed for 20 years or more.

The misdiagnosis problem is also reflected at large MS referral centers, where 30%-67% of patients turn out not to have the disease, Dr. Coyle noted.

study from Argentina further highlights some of the key characteristics of misdiagnosis. In this study, examination of a cohort of 572 patients diagnosed with MS revealed that 16% were incorrectly diagnosed with MS and that women were at an 83% greater risk for misdiagnosis than men. Furthermore, the study showed that MS misdiagnosis increased by 8% per year of older age. The most frequent confirmed diagnoses among those who had been initially misdiagnosed as having MS were cerebrovascular disease, radiologically isolated syndrome, and headache.

The majority (83%) of patients incorrectly diagnosed with MS had an atypical presentation that did not indicate demyelination, 70% had an atypical brain magnetic resonance imaging, and 61% received a prescription for a disease-modifying treatment (DMT), despite not having confirmed MS.
 

The dangers of misdiagnosis

Misdiagnosis and incorrect treatment can be particularly dangerous if patients are diagnosed with MS when, in fact, they have neuromyelitis optica spectrum disorder (NMOSD), commonly mistaken for MS, Dr. Coyle noted.

“Several MS DMTs make NMOSD worse. You are also basically giving an unnecessary and inappropriate drug with potential side effects to the misdiagnosed patient,” she said.

There have been some advances in MS diagnosis on MRI. However, there are many caveats, Dr. Coyle noted.

For instance, leptomeningeal enhancement has been considered as an MS diagnostic indicator, but it is not unique to MS, Dr. Coyle noted. In addition, subpial demyelination is MS specific, but it is hard to see and is often missed, she added.

Central vein sign has received significant attention as an important MRI marker for MS, but, Dr. Coyle said, it is “not ready for prime time. It’s somewhat tedious and you need to use special protocols to identify it,” she said.

In the future, artificial intelligence and deep learning may be key to improving some of these technologies, Dr. Coyle noted.
 

Best hope for an accurate diagnosis

In the meantime, Dr. Coyle said she believes spinal fluid evaluation offers the best chance for a reliable MS diagnosis and is her preference. “I personally find spinal fluid to be extremely helpful to support MS diagnosis. Spinal fluid oligoclonal bands are positive in the vast majority of people with MS, and it is an independent finding from MRI to support an MS diagnosis. Added to MRI, it makes you much more comfortable,” she said.

Dr. Coyle said that a comprehensive workup should include:

  • A thorough neurologic history and exam.
  • MRI of the brain and spinal cord ensuring use of the MS protocol, and personally reading the studies with a neuroradiologist.
  • Adding spinal fluid evaluation, especially in any atypical cases.
  • Ruling out myelin oligodendrocyte glycoprotein antibody disease and NMOSD, diseases that mimic relapsing MS, via blood IgG to aquaporin 4.

“You want to be as certain as possible. Everything starts with a thorough workup,” Dr. Coyle said.

Dr. Coyle’s disclosures include consulting, nonbranded speaker fees, and/or research support with Actelion, Alkermes, Accordant, Biogen, Bristol Myers Squibb, Celgene, CorEvitas LLC, GlaxoSmithKline, Genentech/Roche, Horizon Therapeutics, Janssen, MedDay, Labcorp, Eli Lilly, Mylan, NINDS, Novartis, Sanofi Genzyme, and TG Therapeutics.

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

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Latest data: COVID vaccine safety, protection, and breakthrough infections in inflammatory, autoimmune diseases

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Fri, 06/16/2023 - 11:39

– The impact of the COVID-19 pandemic on patients with rheumatic and nonrheumatic autoimmune diseases is ongoing and not yet fully comprehended. New data presented at the annual European Congress of Rheumatology, primarily derived from the global COVID-19 in Autoimmune Diseases (COVAD) survey but not limited to it, provide reassurance regarding the protection and safety of COVID-19 vaccines for older and younger adults, as well as for pregnant and breastfeeding women. These data also explore the influence of underlying diseases and medications on breakthrough SARS-CoV-2 infections and infection outcomes.

Safety of vaccines in patients with autoimmune or immune-mediated diseases

Following vaccination, even with low levels of antibodies, the risk of severe COVID-19 remains relatively low for patients who receive immunosuppressive therapy for various immune-mediated inflammatory diseases (IMIDs). This encouraging finding comes from the Nor-vaC study, presented by Hilde Ørbo, MD, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases, Diakonhjemmet Hospital, Oslo.

During the presentation, Dr. Ørbo stated: “We did not find any specific diagnosis or medication associated with a significantly higher risk of hospitalization.” Receiving booster doses of the vaccine, having high levels of anti-spike antibodies after vaccination, and achieving hybrid immunity are correlated with further reductions in the risk of breakthrough SARS-CoV-2 infections.

Dr. Hilde Ørbo
Dr. Hilde Ørbo

Between Feb. 15, 2021, and Feb. 15, 2023, COVID-19 affected a similar proportion among the 729 patients and 350 healthy control persons (67% and 68%, respectively). Among the patients, 22 reported severe COVID-19, whereas none of the healthy control persons did. However, there were no fatalities among the patients. The study cohort consisted of patients with various IMIDs; 70% had an inflammatory joint disease. The use of immunosuppressive medications also varied, with 63% of patients using tumor necrosis factor inhibitors, either as monotherapy or in combination with other treatments, and other patients taking medications such as methotrexate, interleukin inhibitors, Janus kinase inhibitors, vedolizumab (Entyvio), and others.

While being older than 70 years and the presence of comorbidities were identified as risk factors for severe COVID-19, there was a significant reduction in risk with each additional vaccine dose. These results support the protective role of repeated COVID-19 vaccination for patients with IMIDs who are receiving immunosuppressive therapies; they yield a favorable prognosis even with the Omicron variant.

The study further compared the risk of severe COVID-19 between a group with hybrid immunity (having received three vaccine doses and experiencing breakthrough infection with the Omicron variant) and a group that received a fourth vaccine dose within the same time frame. The difference was striking: Hybrid immunity was associated with a 5.8-fold decrease in risk, compared with four-dose vaccination (P < .0001).

The level of antibodies, measured 2-4 weeks after the last vaccination, was predictive of the risk of breakthrough COVID-19. An antibody level above 6000 binding antibody units/mL after vaccination was significantly associated with a reduction in risk. “We can conclude that patients who receive multiple vaccine doses have a lower risk of COVID-19,” Dr. Ørbo said. “In patients who recently experienced breakthrough infections, the administration of a booster vaccine dose might be delayed.”

EULAR
Dr. Hendrik Schulze-Koops

“The virus has undergone changes throughout the pandemic, while the vaccines have remained relatively stable. Are we anticipating more infections over time?” asked Hendrik Schulze-Koops, MD, PhD, of Ludwig Maximilians University of Munich (Germany), the session moderator. In response, Dr. Ørbo stated that 85% of the recorded infections in the study occurred after the emergence of the Omicron variant, and time was considered a covariable in the analysis.

These data shed light on a topic discussed by Pedro Machado, MD, PhD, professor and consultant in rheumatology and neuromuscular diseases at University College London, during his scientific session talk entitled, “Unsolved Issues of COVID Vaccination and Re-vaccination.” Dr. Machado referred to the VROOM study published in 2022, which examined the interruption of methotrexate for 2 weeks following booster administration. Both groups demonstrated a significant antibody response, but the group that stopped taking methotrexate showed double the antibody titers.

Dr. Pedro Machado

However, he emphasized, “what remains unknown is the clinical relevance of these differences in terms of severe infection, hospitalization, or even death. The potential benefit of increased immunogenicity by interrupting conventional synthetic disease-modifying antirheumatic drugs [csDMARDs] such as methotrexate before or after vaccination needs to be balanced against the potential risk of disease flare. Ultimately, decision-making should be individualized based on factors such as comorbidities, disease activity, and other considerations.” The results presented by Dr. Ørbo suggest that, while there may be a clinical difference in terms of severe infection, the overall prognosis for vaccinated patients is reasonably good.

Regarding other DMARDs, such as biologics, the approach may differ. Dr. Machado suggested: “In patients using rituximab or other B cell–depleting therapies, SARS-CoV-2 vaccination should be scheduled in a way that optimizes vaccine immunogenicity. A minimum of 10 B cells/mcL of blood is likely a relevant threshold above which a sufficient cellular and immune response is established.”
 

 

 

COVID vaccines are safe for pregnant and breastfeeding women

According to data from the COVAD study, which comprised two global cross-sectional surveys conducted in 2021 and 2022, the COVID-19 vaccine appeared safe for pregnant and breastfeeding women with autoimmune diseases (AID).

Presenter Laura Andreoli, MD, PhD, of the University of Brescia (Italy), said that, although pregnant patients with AID reported more adverse events related to vaccination, these rates were not significantly higher than those among pregnant, healthy control persons who were without AID. No difference in adverse events was observed between breastfeeding women and healthy control persons, and the incidence of disease flares did not significantly differ among all groups.

“In summary, this study provides initial insights into the safety of COVID-19 vaccination during the gestational and postpartum periods in women with autoimmune diseases. These reassuring observations will hopefully improve clinician-patient communication and address hesitancy towards COVID-19 vaccination, as the benefits for the mother and fetus through passive immunization appear to outweigh potential risks,” Dr. Andreoli said in an interview.

“The large number of participants and the global geographical spread of the COVAD survey were very beneficial in gaining access to this important subset of patients,” added Dr. Andreoli. However, she acknowledged that patients with low socioeconomic status and/or high disability were likely underrepresented. While no data on pregnancy outcomes have been collected thus far, Dr. Andreoli expressed the desire to include them in the study’s follow-up.

The COVAD survey data also indicate that, in general, vaccine hesitancy among patients with AID is decreasing; from 2021 to 2022, it declined from 16.5% to 5.1%, as Dr. Machado indicated in his presentation.
 

Multiple factors contribute to breakthrough infections

The risk of breakthrough SARS-CoV-2 infections after vaccination varies among patients with rheumatoid arthritis and rheumatic or nonrheumatic autoimmune diseases, primarily depending on the underlying condition rather than the immunosuppressive medication. Environmental factors also appear to play a role. This complex landscape emerges from a further analysis of the COVAD survey dataset.

Dr. Alessia Alunno

Alessia Alunno, MD, PhD, of the University of L’Aquila (Italy), presented a detailed and occasionally counterintuitive picture of similarities and differences among young adult patients (aged 18-35 years), mostly women, with various rheumatic and nonrheumatic diseases in relation to COVID-19. Most notably, the type of disease seemed to have more significance than the immunosuppression resulting from the treatment regimen. This held true for vaccine safety as well as for the risk of breakthrough COVID-19 and symptom profiles.

Patients with rheumatic disease (RMD) and nonrheumatic autoimmune disease (nr-AD) had significantly different therapeutic profiles on average. Before vaccination, 45% of patients with RMD used glucocorticoids (GC), and 91% used immunosuppressants (IS). In contrast, only 9.5% of nr-AD patients used GC, and 21% were taking IS.

Interestingly, the overall prevalence of reported SARS-CoV-2 infections was not influenced by medication and was practically identical (25% to 28%) across all groups. However, there were intriguing differences in the occurrence of infections before and after vaccination between disease groups. Prevaccine infections were less frequent among patients with RMD compared with healthy control persons (adjusted odds ratio, 0.6), while the rates were similar among patients with nr-AD and healthy control persons. On the other hand, breakthrough infections were more frequent in patients with RMD (aOR, 2.7), whereas the rate was similar between healthy control persons and patients with nr-AD.

Despite a much lower rate of GC/IS use, patients with nr-AD experienced repeated infections more frequently. In contrast, patients with RMD were less prone to multiple infections, even compared with healthy control persons (aOR, 0.5).

Regarding the disease profile, fewer than 5% of all infected patients required advanced therapies for SARS-CoV-2 infection. Notably, all SARS-CoV-2 infections in patients with nr-AD were symptomatic, whereas among patients with RMD and healthy control persons, the incidence of asymptomatic infections was 3%. The rate of hospital admissions was 4% for patients with RMD, compared with 2% for patients with nr-AD and 1% for control persons. The RMD group exhibited some differences between prevaccine infections and breakthrough infections, including a significantly lower frequency of loss of smell and taste during breakthrough infections. Overall, patients with RMD and COVID-19 experienced cough, runny nose, throat pain, nausea, and vomiting more frequently. In contrast, patients with nr-AD had a much higher risk of skin rashes during breakthrough infections (aOR, 8.7).

Vaccine adverse events (AEs) were also influenced by the underlying disease. Patients with RMD and those with nr-AD were more likely to experience mild AEs after the first or second dose, compared with healthy control persons (adjusted OR, 2.4 and 2.0, respectively). The most common early, mild AEs across all groups were injection-site pain, headache, and fatigue, but they occurred more frequently in the nr-AD group than in the RMD or healthy control group. Additionally, fever and chills occurred more frequently among the nr-AD group. Late, mild AEs and severe AEs were rare and affected all groups equally.

“The overall incidence of AEs was very low. Our results certainly do not undermine the safety of vaccines,” Dr. Alunno said.

Disease flares were more common after vaccination (10% with RMD and 7% with nr-AD) than after infection (5% with RMD and 1.5% with nr-AD). Furthermore, in many cases, after vaccination, flares required a change of medications, particularly for patients with RMD.

Dr. Naveen Ravichandran
Dr. Naveen Ravichandran

Additional results from the COVAD survey from January to July 2022, presented by Naveen Ravichandran, MD, DM, of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, revealed a higher prevalence (OR, 1.2; P = .001) of breakthrough infections among patients with RA. A total of 22.6% of patients with RA experienced breakthrough infections, compared with 20.6% for patients with other autoimmune rheumatic diseases and 18.4% of healthy control persons. Hospitalizations and the need for advanced treatment were also more common among patients with RA (30.9%) than among healthy control persons (13.9%). Patients with RA who had breakthrough infections tended to be older (closer to 50 years of age on average) and female, and they were more likely to have comorbidities and mental disorders. The human development index of the patient’s country of residence also played a role. Further research is necessary to understand how breakthrough infection outcomes are affected by a patient’s socioeconomic situation.

According to Dr. Ravichandran, medication was not a significant factor, except for the use of steroids and rituximab, which were associated with a higher risk of severe COVID-19 and hospitalization. Patients using rituximab, in particular, faced significantly increased odds for hospitalization (OR, 3.4) and severe breakthrough COVID-19 (OR, 3.0).

Dr. Kim Lauper

Session moderator Kim Lauper, MD, of the University of Geneva, cautioned: “The roles of disease and medication are challenging to separate. Some diseases require a more aggressive immunosuppressive regimen. It’s possible that different diseases affect the immune system differently, but it is not easy to demonstrate.”

The complications observed in the data warrant further study, as mentioned by Dr. Schulze-Koops: “We have a problem tied to the time line of the pandemic, where we had different viruses, different population behaviors, different treatments, and different standards of care over time. We also have differences between ethnic communities and regions of the world. But most importantly, we have different viruses: From the original strain to Delta to Omicron, we know they have very different clinical outcomes. I believe we need more scientific research to unravel these factors.”

Dr. Ørbo, Dr. Ravichandran, Dr. Andreoli, and Dr. Alunno reported no relevant financial relationships. Dr. Machado has received grants and/or honoraria from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Orphazyme, Pfizer, Roche, and UCB.

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

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– The impact of the COVID-19 pandemic on patients with rheumatic and nonrheumatic autoimmune diseases is ongoing and not yet fully comprehended. New data presented at the annual European Congress of Rheumatology, primarily derived from the global COVID-19 in Autoimmune Diseases (COVAD) survey but not limited to it, provide reassurance regarding the protection and safety of COVID-19 vaccines for older and younger adults, as well as for pregnant and breastfeeding women. These data also explore the influence of underlying diseases and medications on breakthrough SARS-CoV-2 infections and infection outcomes.

Safety of vaccines in patients with autoimmune or immune-mediated diseases

Following vaccination, even with low levels of antibodies, the risk of severe COVID-19 remains relatively low for patients who receive immunosuppressive therapy for various immune-mediated inflammatory diseases (IMIDs). This encouraging finding comes from the Nor-vaC study, presented by Hilde Ørbo, MD, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases, Diakonhjemmet Hospital, Oslo.

During the presentation, Dr. Ørbo stated: “We did not find any specific diagnosis or medication associated with a significantly higher risk of hospitalization.” Receiving booster doses of the vaccine, having high levels of anti-spike antibodies after vaccination, and achieving hybrid immunity are correlated with further reductions in the risk of breakthrough SARS-CoV-2 infections.

Dr. Hilde Ørbo
Dr. Hilde Ørbo

Between Feb. 15, 2021, and Feb. 15, 2023, COVID-19 affected a similar proportion among the 729 patients and 350 healthy control persons (67% and 68%, respectively). Among the patients, 22 reported severe COVID-19, whereas none of the healthy control persons did. However, there were no fatalities among the patients. The study cohort consisted of patients with various IMIDs; 70% had an inflammatory joint disease. The use of immunosuppressive medications also varied, with 63% of patients using tumor necrosis factor inhibitors, either as monotherapy or in combination with other treatments, and other patients taking medications such as methotrexate, interleukin inhibitors, Janus kinase inhibitors, vedolizumab (Entyvio), and others.

While being older than 70 years and the presence of comorbidities were identified as risk factors for severe COVID-19, there was a significant reduction in risk with each additional vaccine dose. These results support the protective role of repeated COVID-19 vaccination for patients with IMIDs who are receiving immunosuppressive therapies; they yield a favorable prognosis even with the Omicron variant.

The study further compared the risk of severe COVID-19 between a group with hybrid immunity (having received three vaccine doses and experiencing breakthrough infection with the Omicron variant) and a group that received a fourth vaccine dose within the same time frame. The difference was striking: Hybrid immunity was associated with a 5.8-fold decrease in risk, compared with four-dose vaccination (P < .0001).

The level of antibodies, measured 2-4 weeks after the last vaccination, was predictive of the risk of breakthrough COVID-19. An antibody level above 6000 binding antibody units/mL after vaccination was significantly associated with a reduction in risk. “We can conclude that patients who receive multiple vaccine doses have a lower risk of COVID-19,” Dr. Ørbo said. “In patients who recently experienced breakthrough infections, the administration of a booster vaccine dose might be delayed.”

EULAR
Dr. Hendrik Schulze-Koops

“The virus has undergone changes throughout the pandemic, while the vaccines have remained relatively stable. Are we anticipating more infections over time?” asked Hendrik Schulze-Koops, MD, PhD, of Ludwig Maximilians University of Munich (Germany), the session moderator. In response, Dr. Ørbo stated that 85% of the recorded infections in the study occurred after the emergence of the Omicron variant, and time was considered a covariable in the analysis.

These data shed light on a topic discussed by Pedro Machado, MD, PhD, professor and consultant in rheumatology and neuromuscular diseases at University College London, during his scientific session talk entitled, “Unsolved Issues of COVID Vaccination and Re-vaccination.” Dr. Machado referred to the VROOM study published in 2022, which examined the interruption of methotrexate for 2 weeks following booster administration. Both groups demonstrated a significant antibody response, but the group that stopped taking methotrexate showed double the antibody titers.

Dr. Pedro Machado

However, he emphasized, “what remains unknown is the clinical relevance of these differences in terms of severe infection, hospitalization, or even death. The potential benefit of increased immunogenicity by interrupting conventional synthetic disease-modifying antirheumatic drugs [csDMARDs] such as methotrexate before or after vaccination needs to be balanced against the potential risk of disease flare. Ultimately, decision-making should be individualized based on factors such as comorbidities, disease activity, and other considerations.” The results presented by Dr. Ørbo suggest that, while there may be a clinical difference in terms of severe infection, the overall prognosis for vaccinated patients is reasonably good.

Regarding other DMARDs, such as biologics, the approach may differ. Dr. Machado suggested: “In patients using rituximab or other B cell–depleting therapies, SARS-CoV-2 vaccination should be scheduled in a way that optimizes vaccine immunogenicity. A minimum of 10 B cells/mcL of blood is likely a relevant threshold above which a sufficient cellular and immune response is established.”
 

 

 

COVID vaccines are safe for pregnant and breastfeeding women

According to data from the COVAD study, which comprised two global cross-sectional surveys conducted in 2021 and 2022, the COVID-19 vaccine appeared safe for pregnant and breastfeeding women with autoimmune diseases (AID).

Presenter Laura Andreoli, MD, PhD, of the University of Brescia (Italy), said that, although pregnant patients with AID reported more adverse events related to vaccination, these rates were not significantly higher than those among pregnant, healthy control persons who were without AID. No difference in adverse events was observed between breastfeeding women and healthy control persons, and the incidence of disease flares did not significantly differ among all groups.

“In summary, this study provides initial insights into the safety of COVID-19 vaccination during the gestational and postpartum periods in women with autoimmune diseases. These reassuring observations will hopefully improve clinician-patient communication and address hesitancy towards COVID-19 vaccination, as the benefits for the mother and fetus through passive immunization appear to outweigh potential risks,” Dr. Andreoli said in an interview.

“The large number of participants and the global geographical spread of the COVAD survey were very beneficial in gaining access to this important subset of patients,” added Dr. Andreoli. However, she acknowledged that patients with low socioeconomic status and/or high disability were likely underrepresented. While no data on pregnancy outcomes have been collected thus far, Dr. Andreoli expressed the desire to include them in the study’s follow-up.

The COVAD survey data also indicate that, in general, vaccine hesitancy among patients with AID is decreasing; from 2021 to 2022, it declined from 16.5% to 5.1%, as Dr. Machado indicated in his presentation.
 

Multiple factors contribute to breakthrough infections

The risk of breakthrough SARS-CoV-2 infections after vaccination varies among patients with rheumatoid arthritis and rheumatic or nonrheumatic autoimmune diseases, primarily depending on the underlying condition rather than the immunosuppressive medication. Environmental factors also appear to play a role. This complex landscape emerges from a further analysis of the COVAD survey dataset.

Dr. Alessia Alunno

Alessia Alunno, MD, PhD, of the University of L’Aquila (Italy), presented a detailed and occasionally counterintuitive picture of similarities and differences among young adult patients (aged 18-35 years), mostly women, with various rheumatic and nonrheumatic diseases in relation to COVID-19. Most notably, the type of disease seemed to have more significance than the immunosuppression resulting from the treatment regimen. This held true for vaccine safety as well as for the risk of breakthrough COVID-19 and symptom profiles.

Patients with rheumatic disease (RMD) and nonrheumatic autoimmune disease (nr-AD) had significantly different therapeutic profiles on average. Before vaccination, 45% of patients with RMD used glucocorticoids (GC), and 91% used immunosuppressants (IS). In contrast, only 9.5% of nr-AD patients used GC, and 21% were taking IS.

Interestingly, the overall prevalence of reported SARS-CoV-2 infections was not influenced by medication and was practically identical (25% to 28%) across all groups. However, there were intriguing differences in the occurrence of infections before and after vaccination between disease groups. Prevaccine infections were less frequent among patients with RMD compared with healthy control persons (adjusted odds ratio, 0.6), while the rates were similar among patients with nr-AD and healthy control persons. On the other hand, breakthrough infections were more frequent in patients with RMD (aOR, 2.7), whereas the rate was similar between healthy control persons and patients with nr-AD.

Despite a much lower rate of GC/IS use, patients with nr-AD experienced repeated infections more frequently. In contrast, patients with RMD were less prone to multiple infections, even compared with healthy control persons (aOR, 0.5).

Regarding the disease profile, fewer than 5% of all infected patients required advanced therapies for SARS-CoV-2 infection. Notably, all SARS-CoV-2 infections in patients with nr-AD were symptomatic, whereas among patients with RMD and healthy control persons, the incidence of asymptomatic infections was 3%. The rate of hospital admissions was 4% for patients with RMD, compared with 2% for patients with nr-AD and 1% for control persons. The RMD group exhibited some differences between prevaccine infections and breakthrough infections, including a significantly lower frequency of loss of smell and taste during breakthrough infections. Overall, patients with RMD and COVID-19 experienced cough, runny nose, throat pain, nausea, and vomiting more frequently. In contrast, patients with nr-AD had a much higher risk of skin rashes during breakthrough infections (aOR, 8.7).

Vaccine adverse events (AEs) were also influenced by the underlying disease. Patients with RMD and those with nr-AD were more likely to experience mild AEs after the first or second dose, compared with healthy control persons (adjusted OR, 2.4 and 2.0, respectively). The most common early, mild AEs across all groups were injection-site pain, headache, and fatigue, but they occurred more frequently in the nr-AD group than in the RMD or healthy control group. Additionally, fever and chills occurred more frequently among the nr-AD group. Late, mild AEs and severe AEs were rare and affected all groups equally.

“The overall incidence of AEs was very low. Our results certainly do not undermine the safety of vaccines,” Dr. Alunno said.

Disease flares were more common after vaccination (10% with RMD and 7% with nr-AD) than after infection (5% with RMD and 1.5% with nr-AD). Furthermore, in many cases, after vaccination, flares required a change of medications, particularly for patients with RMD.

Dr. Naveen Ravichandran
Dr. Naveen Ravichandran

Additional results from the COVAD survey from January to July 2022, presented by Naveen Ravichandran, MD, DM, of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, revealed a higher prevalence (OR, 1.2; P = .001) of breakthrough infections among patients with RA. A total of 22.6% of patients with RA experienced breakthrough infections, compared with 20.6% for patients with other autoimmune rheumatic diseases and 18.4% of healthy control persons. Hospitalizations and the need for advanced treatment were also more common among patients with RA (30.9%) than among healthy control persons (13.9%). Patients with RA who had breakthrough infections tended to be older (closer to 50 years of age on average) and female, and they were more likely to have comorbidities and mental disorders. The human development index of the patient’s country of residence also played a role. Further research is necessary to understand how breakthrough infection outcomes are affected by a patient’s socioeconomic situation.

According to Dr. Ravichandran, medication was not a significant factor, except for the use of steroids and rituximab, which were associated with a higher risk of severe COVID-19 and hospitalization. Patients using rituximab, in particular, faced significantly increased odds for hospitalization (OR, 3.4) and severe breakthrough COVID-19 (OR, 3.0).

Dr. Kim Lauper

Session moderator Kim Lauper, MD, of the University of Geneva, cautioned: “The roles of disease and medication are challenging to separate. Some diseases require a more aggressive immunosuppressive regimen. It’s possible that different diseases affect the immune system differently, but it is not easy to demonstrate.”

The complications observed in the data warrant further study, as mentioned by Dr. Schulze-Koops: “We have a problem tied to the time line of the pandemic, where we had different viruses, different population behaviors, different treatments, and different standards of care over time. We also have differences between ethnic communities and regions of the world. But most importantly, we have different viruses: From the original strain to Delta to Omicron, we know they have very different clinical outcomes. I believe we need more scientific research to unravel these factors.”

Dr. Ørbo, Dr. Ravichandran, Dr. Andreoli, and Dr. Alunno reported no relevant financial relationships. Dr. Machado has received grants and/or honoraria from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Orphazyme, Pfizer, Roche, and UCB.

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

– The impact of the COVID-19 pandemic on patients with rheumatic and nonrheumatic autoimmune diseases is ongoing and not yet fully comprehended. New data presented at the annual European Congress of Rheumatology, primarily derived from the global COVID-19 in Autoimmune Diseases (COVAD) survey but not limited to it, provide reassurance regarding the protection and safety of COVID-19 vaccines for older and younger adults, as well as for pregnant and breastfeeding women. These data also explore the influence of underlying diseases and medications on breakthrough SARS-CoV-2 infections and infection outcomes.

Safety of vaccines in patients with autoimmune or immune-mediated diseases

Following vaccination, even with low levels of antibodies, the risk of severe COVID-19 remains relatively low for patients who receive immunosuppressive therapy for various immune-mediated inflammatory diseases (IMIDs). This encouraging finding comes from the Nor-vaC study, presented by Hilde Ørbo, MD, of the Center for Treatment of Rheumatic and Musculoskeletal Diseases, Diakonhjemmet Hospital, Oslo.

During the presentation, Dr. Ørbo stated: “We did not find any specific diagnosis or medication associated with a significantly higher risk of hospitalization.” Receiving booster doses of the vaccine, having high levels of anti-spike antibodies after vaccination, and achieving hybrid immunity are correlated with further reductions in the risk of breakthrough SARS-CoV-2 infections.

Dr. Hilde Ørbo
Dr. Hilde Ørbo

Between Feb. 15, 2021, and Feb. 15, 2023, COVID-19 affected a similar proportion among the 729 patients and 350 healthy control persons (67% and 68%, respectively). Among the patients, 22 reported severe COVID-19, whereas none of the healthy control persons did. However, there were no fatalities among the patients. The study cohort consisted of patients with various IMIDs; 70% had an inflammatory joint disease. The use of immunosuppressive medications also varied, with 63% of patients using tumor necrosis factor inhibitors, either as monotherapy or in combination with other treatments, and other patients taking medications such as methotrexate, interleukin inhibitors, Janus kinase inhibitors, vedolizumab (Entyvio), and others.

While being older than 70 years and the presence of comorbidities were identified as risk factors for severe COVID-19, there was a significant reduction in risk with each additional vaccine dose. These results support the protective role of repeated COVID-19 vaccination for patients with IMIDs who are receiving immunosuppressive therapies; they yield a favorable prognosis even with the Omicron variant.

The study further compared the risk of severe COVID-19 between a group with hybrid immunity (having received three vaccine doses and experiencing breakthrough infection with the Omicron variant) and a group that received a fourth vaccine dose within the same time frame. The difference was striking: Hybrid immunity was associated with a 5.8-fold decrease in risk, compared with four-dose vaccination (P < .0001).

The level of antibodies, measured 2-4 weeks after the last vaccination, was predictive of the risk of breakthrough COVID-19. An antibody level above 6000 binding antibody units/mL after vaccination was significantly associated with a reduction in risk. “We can conclude that patients who receive multiple vaccine doses have a lower risk of COVID-19,” Dr. Ørbo said. “In patients who recently experienced breakthrough infections, the administration of a booster vaccine dose might be delayed.”

EULAR
Dr. Hendrik Schulze-Koops

“The virus has undergone changes throughout the pandemic, while the vaccines have remained relatively stable. Are we anticipating more infections over time?” asked Hendrik Schulze-Koops, MD, PhD, of Ludwig Maximilians University of Munich (Germany), the session moderator. In response, Dr. Ørbo stated that 85% of the recorded infections in the study occurred after the emergence of the Omicron variant, and time was considered a covariable in the analysis.

These data shed light on a topic discussed by Pedro Machado, MD, PhD, professor and consultant in rheumatology and neuromuscular diseases at University College London, during his scientific session talk entitled, “Unsolved Issues of COVID Vaccination and Re-vaccination.” Dr. Machado referred to the VROOM study published in 2022, which examined the interruption of methotrexate for 2 weeks following booster administration. Both groups demonstrated a significant antibody response, but the group that stopped taking methotrexate showed double the antibody titers.

Dr. Pedro Machado

However, he emphasized, “what remains unknown is the clinical relevance of these differences in terms of severe infection, hospitalization, or even death. The potential benefit of increased immunogenicity by interrupting conventional synthetic disease-modifying antirheumatic drugs [csDMARDs] such as methotrexate before or after vaccination needs to be balanced against the potential risk of disease flare. Ultimately, decision-making should be individualized based on factors such as comorbidities, disease activity, and other considerations.” The results presented by Dr. Ørbo suggest that, while there may be a clinical difference in terms of severe infection, the overall prognosis for vaccinated patients is reasonably good.

Regarding other DMARDs, such as biologics, the approach may differ. Dr. Machado suggested: “In patients using rituximab or other B cell–depleting therapies, SARS-CoV-2 vaccination should be scheduled in a way that optimizes vaccine immunogenicity. A minimum of 10 B cells/mcL of blood is likely a relevant threshold above which a sufficient cellular and immune response is established.”
 

 

 

COVID vaccines are safe for pregnant and breastfeeding women

According to data from the COVAD study, which comprised two global cross-sectional surveys conducted in 2021 and 2022, the COVID-19 vaccine appeared safe for pregnant and breastfeeding women with autoimmune diseases (AID).

Presenter Laura Andreoli, MD, PhD, of the University of Brescia (Italy), said that, although pregnant patients with AID reported more adverse events related to vaccination, these rates were not significantly higher than those among pregnant, healthy control persons who were without AID. No difference in adverse events was observed between breastfeeding women and healthy control persons, and the incidence of disease flares did not significantly differ among all groups.

“In summary, this study provides initial insights into the safety of COVID-19 vaccination during the gestational and postpartum periods in women with autoimmune diseases. These reassuring observations will hopefully improve clinician-patient communication and address hesitancy towards COVID-19 vaccination, as the benefits for the mother and fetus through passive immunization appear to outweigh potential risks,” Dr. Andreoli said in an interview.

“The large number of participants and the global geographical spread of the COVAD survey were very beneficial in gaining access to this important subset of patients,” added Dr. Andreoli. However, she acknowledged that patients with low socioeconomic status and/or high disability were likely underrepresented. While no data on pregnancy outcomes have been collected thus far, Dr. Andreoli expressed the desire to include them in the study’s follow-up.

The COVAD survey data also indicate that, in general, vaccine hesitancy among patients with AID is decreasing; from 2021 to 2022, it declined from 16.5% to 5.1%, as Dr. Machado indicated in his presentation.
 

Multiple factors contribute to breakthrough infections

The risk of breakthrough SARS-CoV-2 infections after vaccination varies among patients with rheumatoid arthritis and rheumatic or nonrheumatic autoimmune diseases, primarily depending on the underlying condition rather than the immunosuppressive medication. Environmental factors also appear to play a role. This complex landscape emerges from a further analysis of the COVAD survey dataset.

Dr. Alessia Alunno

Alessia Alunno, MD, PhD, of the University of L’Aquila (Italy), presented a detailed and occasionally counterintuitive picture of similarities and differences among young adult patients (aged 18-35 years), mostly women, with various rheumatic and nonrheumatic diseases in relation to COVID-19. Most notably, the type of disease seemed to have more significance than the immunosuppression resulting from the treatment regimen. This held true for vaccine safety as well as for the risk of breakthrough COVID-19 and symptom profiles.

Patients with rheumatic disease (RMD) and nonrheumatic autoimmune disease (nr-AD) had significantly different therapeutic profiles on average. Before vaccination, 45% of patients with RMD used glucocorticoids (GC), and 91% used immunosuppressants (IS). In contrast, only 9.5% of nr-AD patients used GC, and 21% were taking IS.

Interestingly, the overall prevalence of reported SARS-CoV-2 infections was not influenced by medication and was practically identical (25% to 28%) across all groups. However, there were intriguing differences in the occurrence of infections before and after vaccination between disease groups. Prevaccine infections were less frequent among patients with RMD compared with healthy control persons (adjusted odds ratio, 0.6), while the rates were similar among patients with nr-AD and healthy control persons. On the other hand, breakthrough infections were more frequent in patients with RMD (aOR, 2.7), whereas the rate was similar between healthy control persons and patients with nr-AD.

Despite a much lower rate of GC/IS use, patients with nr-AD experienced repeated infections more frequently. In contrast, patients with RMD were less prone to multiple infections, even compared with healthy control persons (aOR, 0.5).

Regarding the disease profile, fewer than 5% of all infected patients required advanced therapies for SARS-CoV-2 infection. Notably, all SARS-CoV-2 infections in patients with nr-AD were symptomatic, whereas among patients with RMD and healthy control persons, the incidence of asymptomatic infections was 3%. The rate of hospital admissions was 4% for patients with RMD, compared with 2% for patients with nr-AD and 1% for control persons. The RMD group exhibited some differences between prevaccine infections and breakthrough infections, including a significantly lower frequency of loss of smell and taste during breakthrough infections. Overall, patients with RMD and COVID-19 experienced cough, runny nose, throat pain, nausea, and vomiting more frequently. In contrast, patients with nr-AD had a much higher risk of skin rashes during breakthrough infections (aOR, 8.7).

Vaccine adverse events (AEs) were also influenced by the underlying disease. Patients with RMD and those with nr-AD were more likely to experience mild AEs after the first or second dose, compared with healthy control persons (adjusted OR, 2.4 and 2.0, respectively). The most common early, mild AEs across all groups were injection-site pain, headache, and fatigue, but they occurred more frequently in the nr-AD group than in the RMD or healthy control group. Additionally, fever and chills occurred more frequently among the nr-AD group. Late, mild AEs and severe AEs were rare and affected all groups equally.

“The overall incidence of AEs was very low. Our results certainly do not undermine the safety of vaccines,” Dr. Alunno said.

Disease flares were more common after vaccination (10% with RMD and 7% with nr-AD) than after infection (5% with RMD and 1.5% with nr-AD). Furthermore, in many cases, after vaccination, flares required a change of medications, particularly for patients with RMD.

Dr. Naveen Ravichandran
Dr. Naveen Ravichandran

Additional results from the COVAD survey from January to July 2022, presented by Naveen Ravichandran, MD, DM, of Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India, revealed a higher prevalence (OR, 1.2; P = .001) of breakthrough infections among patients with RA. A total of 22.6% of patients with RA experienced breakthrough infections, compared with 20.6% for patients with other autoimmune rheumatic diseases and 18.4% of healthy control persons. Hospitalizations and the need for advanced treatment were also more common among patients with RA (30.9%) than among healthy control persons (13.9%). Patients with RA who had breakthrough infections tended to be older (closer to 50 years of age on average) and female, and they were more likely to have comorbidities and mental disorders. The human development index of the patient’s country of residence also played a role. Further research is necessary to understand how breakthrough infection outcomes are affected by a patient’s socioeconomic situation.

According to Dr. Ravichandran, medication was not a significant factor, except for the use of steroids and rituximab, which were associated with a higher risk of severe COVID-19 and hospitalization. Patients using rituximab, in particular, faced significantly increased odds for hospitalization (OR, 3.4) and severe breakthrough COVID-19 (OR, 3.0).

Dr. Kim Lauper

Session moderator Kim Lauper, MD, of the University of Geneva, cautioned: “The roles of disease and medication are challenging to separate. Some diseases require a more aggressive immunosuppressive regimen. It’s possible that different diseases affect the immune system differently, but it is not easy to demonstrate.”

The complications observed in the data warrant further study, as mentioned by Dr. Schulze-Koops: “We have a problem tied to the time line of the pandemic, where we had different viruses, different population behaviors, different treatments, and different standards of care over time. We also have differences between ethnic communities and regions of the world. But most importantly, we have different viruses: From the original strain to Delta to Omicron, we know they have very different clinical outcomes. I believe we need more scientific research to unravel these factors.”

Dr. Ørbo, Dr. Ravichandran, Dr. Andreoli, and Dr. Alunno reported no relevant financial relationships. Dr. Machado has received grants and/or honoraria from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Orphazyme, Pfizer, Roche, and UCB.

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

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ACS officer provides ASCO highlights: Targeting hidden cancer, AI in oncology

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– For the chief patient officer of the American Cancer Society, this year’s annual meeting of the American Society of Clinical Oncology was a gem. And it didn’t just sparkle because of the sequined Taylor Swift fans clogging the nearby streets during the meeting.

Arif Kamal, MD, MBA, MHS, who is also an oncologist at Duke University, Durham, N.C., said he was impressed by a pair of landmark studies released at the meeting that show hidden cancer can be targeted with “really remarkable outcomes.” He also highlighted sessions that examined the role of artificial intelligence (AI) in oncology, during an interview.

Below are lightly edited excerpts from a conversation with Dr. Kamal:



Question: What are some of most groundbreaking studies released at ASCO?

Answer: One is an interim analysis of the NATALEE trial, which involved patients with early-stage hormone receptor-positive, HER2-negative (HR+/HER2–) breast tumors. This phase 3 randomized trial compared maintenance therapy with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) plus endocrine therapy with an aromatase inhibitor to endocrine therapy alone in patients with node-positive or node-negative and stage II or III HR+/HER– breast cancer.

For a long time, the standard care in these patients has been to use endocrine therapy alone. This is the first big trial to show that upstream usage of additional therapy in early stages is also beneficial for disease-free survival. The 3-year invasive disease-free survival rate was 90.4% in the rebociclib-endocrine therapy group vs. 87.1% for patients who received only endocrine therapy (P = .0014).



Q: How do these findings add to current knowledge?

A: Typically, we let people get metastatic disease before we use CDK4/6 inhibitors. These findings show that systemic treatment beyond endocrine therapy will be helpful in cases where you’ve got smaller disease that has not spread yet.

Even in patients with node-negative breast cancer, micrometastatic disease is clearly there, because the medication killed the negative lymph nodes.



Q: What else struck you as especially important research?

A: The NATALEE findings match what we saw in another study – the ADAURA trial, which looked at adjuvant osimertinib in non–small-cell lung cancer patients with EGFR-mutated, stage IB to IIIA disease – cancer that has not spread to the lymph nodes.

This is another example where you have a treatment being used in earlier-stage disease that’s showing really remarkable outcomes. The study found that 5-year overall survival was 88% in an osimertinib group vs. 78% in a placebo group (P < .001). This is a disease where, in stage IB, we wouldn’t even necessarily give these patients treatment at all, other than surgical resection of the tumor and maybe give them a little bit of chemotherapy.

Even in these smaller, early tumors, osimertinib makes a difference.



Q: As a whole, what are these studies telling us about cancer cells that can’t be easily detected?

A: To find a disease-free survival benefit with adding ribociclib in a stage II, stage III setting, particularly in node-negative disease, is remarkable because it says that the cells in hiding are bad actors, and they are going to cause trouble. The study shows that medications can find these cells and reverse that risk of bad outcomes.

If you think about the paradigm of cancer, that’s pretty remarkable because the ADAURA trial does the same thing: You do surgery for [early-stage] lung cancers that have not spread to the lymph nodes and you figure, “Well, I’ve got it all, right? The margins are real big, healthy, clean.” And yet, people still have recurrences, and you ask the same question: “Can any medicine find those few cells, the hundreds of cells that are still left somewhere in hiding?” And the answer is again, yes. It’s changing the paradigm of our understanding of minimal residual disease.

That’s why there’s so much interest in liquid biopsies. Let’s say that after treatment we don’t see any cancer radiologically, but there’s a signal from a liquid biopsy [detecting residual cancer]. These two trials demonstrate that there’s something we can do about it.



Q: There were quite a few studies about artificial intelligence released at ASCO. Where do we stand on that front?

A: We’re just at the beginning of people thinking about the use of generative AI for clinical decision support, clinical trial matching, and pathology review. But AI, at least for now, still has the issue of making up things that aren’t true. That’s not something patients are going to be okay with.



Q: How can AI be helpful to medical providers considering its limitations?

A: AI is going to be very good at the data-to-information transition. You’ll start seeing people use AI to start clinical notes for them and to match patients to the best clinical trials for them. But fundamentally, the clinician’s role will continue to be to check facts and offer wisdom.



Q: Will AI threaten the careers of oncologists?

A: The body of knowledge about oncology is growing exponentially, and no one can actually keep up. There’s so much data that’s out there that needs to be turned into usable information amid a shortage of oncologists. At the same time, the prevalence of cancer is going up, even though mortality is going down.

Synthesis of data is what oncologists are waiting for from AI. They’ll welcome it as opposed to being worried. That’s the sentiment I heard from my colleagues.

Dr. Kamal has no disclosures.

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– For the chief patient officer of the American Cancer Society, this year’s annual meeting of the American Society of Clinical Oncology was a gem. And it didn’t just sparkle because of the sequined Taylor Swift fans clogging the nearby streets during the meeting.

Arif Kamal, MD, MBA, MHS, who is also an oncologist at Duke University, Durham, N.C., said he was impressed by a pair of landmark studies released at the meeting that show hidden cancer can be targeted with “really remarkable outcomes.” He also highlighted sessions that examined the role of artificial intelligence (AI) in oncology, during an interview.

Below are lightly edited excerpts from a conversation with Dr. Kamal:



Question: What are some of most groundbreaking studies released at ASCO?

Answer: One is an interim analysis of the NATALEE trial, which involved patients with early-stage hormone receptor-positive, HER2-negative (HR+/HER2–) breast tumors. This phase 3 randomized trial compared maintenance therapy with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) plus endocrine therapy with an aromatase inhibitor to endocrine therapy alone in patients with node-positive or node-negative and stage II or III HR+/HER– breast cancer.

For a long time, the standard care in these patients has been to use endocrine therapy alone. This is the first big trial to show that upstream usage of additional therapy in early stages is also beneficial for disease-free survival. The 3-year invasive disease-free survival rate was 90.4% in the rebociclib-endocrine therapy group vs. 87.1% for patients who received only endocrine therapy (P = .0014).



Q: How do these findings add to current knowledge?

A: Typically, we let people get metastatic disease before we use CDK4/6 inhibitors. These findings show that systemic treatment beyond endocrine therapy will be helpful in cases where you’ve got smaller disease that has not spread yet.

Even in patients with node-negative breast cancer, micrometastatic disease is clearly there, because the medication killed the negative lymph nodes.



Q: What else struck you as especially important research?

A: The NATALEE findings match what we saw in another study – the ADAURA trial, which looked at adjuvant osimertinib in non–small-cell lung cancer patients with EGFR-mutated, stage IB to IIIA disease – cancer that has not spread to the lymph nodes.

This is another example where you have a treatment being used in earlier-stage disease that’s showing really remarkable outcomes. The study found that 5-year overall survival was 88% in an osimertinib group vs. 78% in a placebo group (P < .001). This is a disease where, in stage IB, we wouldn’t even necessarily give these patients treatment at all, other than surgical resection of the tumor and maybe give them a little bit of chemotherapy.

Even in these smaller, early tumors, osimertinib makes a difference.



Q: As a whole, what are these studies telling us about cancer cells that can’t be easily detected?

A: To find a disease-free survival benefit with adding ribociclib in a stage II, stage III setting, particularly in node-negative disease, is remarkable because it says that the cells in hiding are bad actors, and they are going to cause trouble. The study shows that medications can find these cells and reverse that risk of bad outcomes.

If you think about the paradigm of cancer, that’s pretty remarkable because the ADAURA trial does the same thing: You do surgery for [early-stage] lung cancers that have not spread to the lymph nodes and you figure, “Well, I’ve got it all, right? The margins are real big, healthy, clean.” And yet, people still have recurrences, and you ask the same question: “Can any medicine find those few cells, the hundreds of cells that are still left somewhere in hiding?” And the answer is again, yes. It’s changing the paradigm of our understanding of minimal residual disease.

That’s why there’s so much interest in liquid biopsies. Let’s say that after treatment we don’t see any cancer radiologically, but there’s a signal from a liquid biopsy [detecting residual cancer]. These two trials demonstrate that there’s something we can do about it.



Q: There were quite a few studies about artificial intelligence released at ASCO. Where do we stand on that front?

A: We’re just at the beginning of people thinking about the use of generative AI for clinical decision support, clinical trial matching, and pathology review. But AI, at least for now, still has the issue of making up things that aren’t true. That’s not something patients are going to be okay with.



Q: How can AI be helpful to medical providers considering its limitations?

A: AI is going to be very good at the data-to-information transition. You’ll start seeing people use AI to start clinical notes for them and to match patients to the best clinical trials for them. But fundamentally, the clinician’s role will continue to be to check facts and offer wisdom.



Q: Will AI threaten the careers of oncologists?

A: The body of knowledge about oncology is growing exponentially, and no one can actually keep up. There’s so much data that’s out there that needs to be turned into usable information amid a shortage of oncologists. At the same time, the prevalence of cancer is going up, even though mortality is going down.

Synthesis of data is what oncologists are waiting for from AI. They’ll welcome it as opposed to being worried. That’s the sentiment I heard from my colleagues.

Dr. Kamal has no disclosures.

– For the chief patient officer of the American Cancer Society, this year’s annual meeting of the American Society of Clinical Oncology was a gem. And it didn’t just sparkle because of the sequined Taylor Swift fans clogging the nearby streets during the meeting.

Arif Kamal, MD, MBA, MHS, who is also an oncologist at Duke University, Durham, N.C., said he was impressed by a pair of landmark studies released at the meeting that show hidden cancer can be targeted with “really remarkable outcomes.” He also highlighted sessions that examined the role of artificial intelligence (AI) in oncology, during an interview.

Below are lightly edited excerpts from a conversation with Dr. Kamal:



Question: What are some of most groundbreaking studies released at ASCO?

Answer: One is an interim analysis of the NATALEE trial, which involved patients with early-stage hormone receptor-positive, HER2-negative (HR+/HER2–) breast tumors. This phase 3 randomized trial compared maintenance therapy with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) plus endocrine therapy with an aromatase inhibitor to endocrine therapy alone in patients with node-positive or node-negative and stage II or III HR+/HER– breast cancer.

For a long time, the standard care in these patients has been to use endocrine therapy alone. This is the first big trial to show that upstream usage of additional therapy in early stages is also beneficial for disease-free survival. The 3-year invasive disease-free survival rate was 90.4% in the rebociclib-endocrine therapy group vs. 87.1% for patients who received only endocrine therapy (P = .0014).



Q: How do these findings add to current knowledge?

A: Typically, we let people get metastatic disease before we use CDK4/6 inhibitors. These findings show that systemic treatment beyond endocrine therapy will be helpful in cases where you’ve got smaller disease that has not spread yet.

Even in patients with node-negative breast cancer, micrometastatic disease is clearly there, because the medication killed the negative lymph nodes.



Q: What else struck you as especially important research?

A: The NATALEE findings match what we saw in another study – the ADAURA trial, which looked at adjuvant osimertinib in non–small-cell lung cancer patients with EGFR-mutated, stage IB to IIIA disease – cancer that has not spread to the lymph nodes.

This is another example where you have a treatment being used in earlier-stage disease that’s showing really remarkable outcomes. The study found that 5-year overall survival was 88% in an osimertinib group vs. 78% in a placebo group (P < .001). This is a disease where, in stage IB, we wouldn’t even necessarily give these patients treatment at all, other than surgical resection of the tumor and maybe give them a little bit of chemotherapy.

Even in these smaller, early tumors, osimertinib makes a difference.



Q: As a whole, what are these studies telling us about cancer cells that can’t be easily detected?

A: To find a disease-free survival benefit with adding ribociclib in a stage II, stage III setting, particularly in node-negative disease, is remarkable because it says that the cells in hiding are bad actors, and they are going to cause trouble. The study shows that medications can find these cells and reverse that risk of bad outcomes.

If you think about the paradigm of cancer, that’s pretty remarkable because the ADAURA trial does the same thing: You do surgery for [early-stage] lung cancers that have not spread to the lymph nodes and you figure, “Well, I’ve got it all, right? The margins are real big, healthy, clean.” And yet, people still have recurrences, and you ask the same question: “Can any medicine find those few cells, the hundreds of cells that are still left somewhere in hiding?” And the answer is again, yes. It’s changing the paradigm of our understanding of minimal residual disease.

That’s why there’s so much interest in liquid biopsies. Let’s say that after treatment we don’t see any cancer radiologically, but there’s a signal from a liquid biopsy [detecting residual cancer]. These two trials demonstrate that there’s something we can do about it.



Q: There were quite a few studies about artificial intelligence released at ASCO. Where do we stand on that front?

A: We’re just at the beginning of people thinking about the use of generative AI for clinical decision support, clinical trial matching, and pathology review. But AI, at least for now, still has the issue of making up things that aren’t true. That’s not something patients are going to be okay with.



Q: How can AI be helpful to medical providers considering its limitations?

A: AI is going to be very good at the data-to-information transition. You’ll start seeing people use AI to start clinical notes for them and to match patients to the best clinical trials for them. But fundamentally, the clinician’s role will continue to be to check facts and offer wisdom.



Q: Will AI threaten the careers of oncologists?

A: The body of knowledge about oncology is growing exponentially, and no one can actually keep up. There’s so much data that’s out there that needs to be turned into usable information amid a shortage of oncologists. At the same time, the prevalence of cancer is going up, even though mortality is going down.

Synthesis of data is what oncologists are waiting for from AI. They’ll welcome it as opposed to being worried. That’s the sentiment I heard from my colleagues.

Dr. Kamal has no disclosures.

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