Jim Kling

Postintubation laryngeal and tracheal injuries may be yet another part of recovery from severe COVID-19 infection for some patients.

Evidence has been accumulating on the link between prolonged intubation and lingering breathing and speaking difficulties, a concern that has become more germane in the wake of the COVID-19 pandemic. Now, researchers in Italy led by Giacomo Fiacchini, MD, and Luca Bruschini, MD, of the University of Pisa have published new research suggesting tracheal complications were particularly common in COVID-19 patients intubated for prolonged periods during the pandemic.

The study may be revealing effects of the pandemic itself, as resources and staff were at times overwhelmed by critical care patients. Of the 98 patients admitted from March 1 to May 31, 47% intubated for longer than 14 days developed full-thickness tracheal lesions, compared with 2.2% of a control group treated during the same time frame in 2019. The difference is eye-popping, but may not be generalizable. “I have not observed an increased rate of tracheal injury, but we haven’t carefully studied that outcome as far as I know,” said Daniel Ouellette, MD, FCCP, who is a senior staff physician and director of the pulmonary inpatient unit at Henry Ford Health System, and an associate professor at Wayne State University, Detroit.

He expressed concern about the retrospective nature of the study, and wondered if the different outcomes might be because of disruptions caused by the pandemic. “It’s not hard to imagine that these patients were seen [during] a great rush of patients, whereas the control group was looked at during a period where that kind of volume didn’t exist. There might have been a tendency for more inexperienced practitioners to be intubating patients because they were in the middle of the epidemic. There might have been less supervision of trainees. Individuals, physicians, teams may have been more rushed. Protocols may not have been followed as closely. It may all be an effect of the epidemic itself,” said Dr. Ouellette.

The investigators suggested that implementation of pronation maneuvers may have increased cuff pressure on the tracheal walls leading to some injuries. In addition, the prothrombotic and antifibrinolytic state of patients with COVID-19 may have contributed, along with the impact of systemic steroids that may have altered normal healing of tracheal wall microwounds caused by intubation, cuff pressure, or tracheostomy.

Other research has suggested increased complications from intubation among COVID-19 patients, including a case series that found heightened frequency of pneumomediastinum. The authors of that study suggested that aggressive disease pathophysiology and accompanying risk of alveolar damage and tracheobronchial injury may be to blame, along with larger-bore tracheal tubes and higher ventilation pressures. That study may also be reflecting the conditions of intubation during the pandemic.

Not all institutions saw an uptick in tracheal injury or pneumomediastinum. Mary Jo S. Farmer, MD, PhD, FCCP, of the department of medicine at University of Massachusetts, Springfield, asked one of the institute’s statisticians to examine pneumothorax frequency from March 15, 2020, to March 1, 2021, comparing the rates between patients who tested positive for SARS-CoV-2 within 14 days of admission, and those who tested negative. The rate was 0.5% in patients who tested positive versus 0.4% in those who tested negative. “My division chief’s gut sense is it’s just the same. The prevalence [of pneumomediastinum] is what we were seeing before,” said Dr. Farmer.

Shortly before the COVID-19 pandemic, researchers at Vanderbilt University Medical Center found that more than half of patients undergoing prolonged intubation experience breathing and speaking difficulties at 10 weeks post intubation. The group has followed up that study with another study looking at treatment timing and outcomes.

The researchers reviewed the experiences of 29 patients with laryngeal injury from endotracheal intubation between May 1, 2014,- and June 1, 2018. Ten patients with posterior glottis injury received early treatment, at a median of 34.7 days to presentation (interquartile range, 1.5-44.8 days). Nineteen patients with posterior glottis stenosis received treatment at a median of 341.9 days (absolute difference, 307.2 days; 95% confidence interval, 124.4-523.3 days). Demographic characteristics and comorbidities were similar between the two groups. At last follow-up, 90% of the early-treatment group were decannulated, compared with 58% of the late group (absolute difference, 32%; 95% CI, –3% to 68%). The early group required a mean of 2.2 interventions, compared with 11.5 in the late group (absolute difference, 9.3; 95% CI, 6.4-12.1). No patients in the early group required an open procedure, compared with 90% of the late-treatment group.

Although early treatment seems promising, the timing of laryngeal injury repair would be a key consideration. “You would worry about patient stability, [making] sure they’re clinically stable and didn’t have any acute ill effects from the injury itself or the underlying illness that led to intubation,” said Dr. Ouellette. For COVID-19 patients, that would mean recovery from pneumonia or any other lung problems, he added.

Together, the studies raise concerns and questions over tracheal and laryngeal injury in the context of COVID-19, but fall short of providing clinical guidance. “It raises the awareness in the mind of the critical care physician about these potential injuries to the larynx surrounding intubation,” said Dr. Farmer.

The studies received no funding. Dr. Ouellette and Dr. Farmer reported no relevant financial disclosures.

Postintubation laryngeal and tracheal injuries may be yet another part of recovery from severe COVID-19 infection for some patients.

Evidence has been accumulating on the link between prolonged intubation and lingering breathing and speaking difficulties, a concern that has become more germane in the wake of the COVID-19 pandemic. Now, researchers in Italy led by Giacomo Fiacchini, MD, and Luca Bruschini, MD, of the University of Pisa have published new research suggesting tracheal complications were particularly common in COVID-19 patients intubated for prolonged periods during the pandemic.

The study may be revealing effects of the pandemic itself, as resources and staff were at times overwhelmed by critical care patients. Of the 98 patients admitted from March 1 to May 31, 47% intubated for longer than 14 days developed full-thickness tracheal lesions, compared with 2.2% of a control group treated during the same time frame in 2019. The difference is eye-popping, but may not be generalizable. “I have not observed an increased rate of tracheal injury, but we haven’t carefully studied that outcome as far as I know,” said Daniel Ouellette, MD, FCCP, who is a senior staff physician and director of the pulmonary inpatient unit at Henry Ford Health System, and an associate professor at Wayne State University, Detroit.

He expressed concern about the retrospective nature of the study, and wondered if the different outcomes might be because of disruptions caused by the pandemic. “It’s not hard to imagine that these patients were seen [during] a great rush of patients, whereas the control group was looked at during a period where that kind of volume didn’t exist. There might have been a tendency for more inexperienced practitioners to be intubating patients because they were in the middle of the epidemic. There might have been less supervision of trainees. Individuals, physicians, teams may have been more rushed. Protocols may not have been followed as closely. It may all be an effect of the epidemic itself,” said Dr. Ouellette.

The investigators suggested that implementation of pronation maneuvers may have increased cuff pressure on the tracheal walls leading to some injuries. In addition, the prothrombotic and antifibrinolytic state of patients with COVID-19 may have contributed, along with the impact of systemic steroids that may have altered normal healing of tracheal wall microwounds caused by intubation, cuff pressure, or tracheostomy.

Other research has suggested increased complications from intubation among COVID-19 patients, including a case series that found heightened frequency of pneumomediastinum. The authors of that study suggested that aggressive disease pathophysiology and accompanying risk of alveolar damage and tracheobronchial injury may be to blame, along with larger-bore tracheal tubes and higher ventilation pressures. That study may also be reflecting the conditions of intubation during the pandemic.

Not all institutions saw an uptick in tracheal injury or pneumomediastinum. Mary Jo S. Farmer, MD, PhD, FCCP, of the department of medicine at University of Massachusetts, Springfield, asked one of the institute’s statisticians to examine pneumothorax frequency from March 15, 2020, to March 1, 2021, comparing the rates between patients who tested positive for SARS-CoV-2 within 14 days of admission, and those who tested negative. The rate was 0.5% in patients who tested positive versus 0.4% in those who tested negative. “My division chief’s gut sense is it’s just the same. The prevalence [of pneumomediastinum] is what we were seeing before,” said Dr. Farmer.

Shortly before the COVID-19 pandemic, researchers at Vanderbilt University Medical Center found that more than half of patients undergoing prolonged intubation experience breathing and speaking difficulties at 10 weeks post intubation. The group has followed up that study with another study looking at treatment timing and outcomes.

The researchers reviewed the experiences of 29 patients with laryngeal injury from endotracheal intubation between May 1, 2014,- and June 1, 2018. Ten patients with posterior glottis injury received early treatment, at a median of 34.7 days to presentation (interquartile range, 1.5-44.8 days). Nineteen patients with posterior glottis stenosis received treatment at a median of 341.9 days (absolute difference, 307.2 days; 95% confidence interval, 124.4-523.3 days). Demographic characteristics and comorbidities were similar between the two groups. At last follow-up, 90% of the early-treatment group were decannulated, compared with 58% of the late group (absolute difference, 32%; 95% CI, –3% to 68%). The early group required a mean of 2.2 interventions, compared with 11.5 in the late group (absolute difference, 9.3; 95% CI, 6.4-12.1). No patients in the early group required an open procedure, compared with 90% of the late-treatment group.

Although early treatment seems promising, the timing of laryngeal injury repair would be a key consideration. “You would worry about patient stability, [making] sure they’re clinically stable and didn’t have any acute ill effects from the injury itself or the underlying illness that led to intubation,” said Dr. Ouellette. For COVID-19 patients, that would mean recovery from pneumonia or any other lung problems, he added.

Together, the studies raise concerns and questions over tracheal and laryngeal injury in the context of COVID-19, but fall short of providing clinical guidance. “It raises the awareness in the mind of the critical care physician about these potential injuries to the larynx surrounding intubation,” said Dr. Farmer.

The studies received no funding. Dr. Ouellette and Dr. Farmer reported no relevant financial disclosures.

Postintubation laryngeal and tracheal injuries may be yet another part of recovery from severe COVID-19 infection for some patients.

Evidence has been accumulating on the link between prolonged intubation and lingering breathing and speaking difficulties, a concern that has become more germane in the wake of the COVID-19 pandemic. Now, researchers in Italy led by Giacomo Fiacchini, MD, and Luca Bruschini, MD, of the University of Pisa have published new research suggesting tracheal complications were particularly common in COVID-19 patients intubated for prolonged periods during the pandemic.

The study may be revealing effects of the pandemic itself, as resources and staff were at times overwhelmed by critical care patients. Of the 98 patients admitted from March 1 to May 31, 47% intubated for longer than 14 days developed full-thickness tracheal lesions, compared with 2.2% of a control group treated during the same time frame in 2019. The difference is eye-popping, but may not be generalizable. “I have not observed an increased rate of tracheal injury, but we haven’t carefully studied that outcome as far as I know,” said Daniel Ouellette, MD, FCCP, who is a senior staff physician and director of the pulmonary inpatient unit at Henry Ford Health System, and an associate professor at Wayne State University, Detroit.

He expressed concern about the retrospective nature of the study, and wondered if the different outcomes might be because of disruptions caused by the pandemic. “It’s not hard to imagine that these patients were seen [during] a great rush of patients, whereas the control group was looked at during a period where that kind of volume didn’t exist. There might have been a tendency for more inexperienced practitioners to be intubating patients because they were in the middle of the epidemic. There might have been less supervision of trainees. Individuals, physicians, teams may have been more rushed. Protocols may not have been followed as closely. It may all be an effect of the epidemic itself,” said Dr. Ouellette.

The investigators suggested that implementation of pronation maneuvers may have increased cuff pressure on the tracheal walls leading to some injuries. In addition, the prothrombotic and antifibrinolytic state of patients with COVID-19 may have contributed, along with the impact of systemic steroids that may have altered normal healing of tracheal wall microwounds caused by intubation, cuff pressure, or tracheostomy.

Other research has suggested increased complications from intubation among COVID-19 patients, including a case series that found heightened frequency of pneumomediastinum. The authors of that study suggested that aggressive disease pathophysiology and accompanying risk of alveolar damage and tracheobronchial injury may be to blame, along with larger-bore tracheal tubes and higher ventilation pressures. That study may also be reflecting the conditions of intubation during the pandemic.

Not all institutions saw an uptick in tracheal injury or pneumomediastinum. Mary Jo S. Farmer, MD, PhD, FCCP, of the department of medicine at University of Massachusetts, Springfield, asked one of the institute’s statisticians to examine pneumothorax frequency from March 15, 2020, to March 1, 2021, comparing the rates between patients who tested positive for SARS-CoV-2 within 14 days of admission, and those who tested negative. The rate was 0.5% in patients who tested positive versus 0.4% in those who tested negative. “My division chief’s gut sense is it’s just the same. The prevalence [of pneumomediastinum] is what we were seeing before,” said Dr. Farmer.

Shortly before the COVID-19 pandemic, researchers at Vanderbilt University Medical Center found that more than half of patients undergoing prolonged intubation experience breathing and speaking difficulties at 10 weeks post intubation. The group has followed up that study with another study looking at treatment timing and outcomes.

The researchers reviewed the experiences of 29 patients with laryngeal injury from endotracheal intubation between May 1, 2014,- and June 1, 2018. Ten patients with posterior glottis injury received early treatment, at a median of 34.7 days to presentation (interquartile range, 1.5-44.8 days). Nineteen patients with posterior glottis stenosis received treatment at a median of 341.9 days (absolute difference, 307.2 days; 95% confidence interval, 124.4-523.3 days). Demographic characteristics and comorbidities were similar between the two groups. At last follow-up, 90% of the early-treatment group were decannulated, compared with 58% of the late group (absolute difference, 32%; 95% CI, –3% to 68%). The early group required a mean of 2.2 interventions, compared with 11.5 in the late group (absolute difference, 9.3; 95% CI, 6.4-12.1). No patients in the early group required an open procedure, compared with 90% of the late-treatment group.

Although early treatment seems promising, the timing of laryngeal injury repair would be a key consideration. “You would worry about patient stability, [making] sure they’re clinically stable and didn’t have any acute ill effects from the injury itself or the underlying illness that led to intubation,” said Dr. Ouellette. For COVID-19 patients, that would mean recovery from pneumonia or any other lung problems, he added.

Together, the studies raise concerns and questions over tracheal and laryngeal injury in the context of COVID-19, but fall short of providing clinical guidance. “It raises the awareness in the mind of the critical care physician about these potential injuries to the larynx surrounding intubation,” said Dr. Farmer.

The studies received no funding. Dr. Ouellette and Dr. Farmer reported no relevant financial disclosures.

COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.

They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.

The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.

There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Dr. Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”

There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.

There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.

A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Dr. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.

copyright DesignPics/Thinkstock

No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.

The guidance includes some recommendations for specific osteoporosis medications.

• Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.
• Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.
• Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.
• Teriparatide and abaloparatide should be continued.
• Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.
• Raloxifene should be continued in patients receiving COVID-19 vaccination.

Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

Dr. Jan De Beur has no relevant financial disclosures.

COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.

They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.

The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.

There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Dr. Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”

There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.

There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.

A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Dr. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.

copyright DesignPics/Thinkstock

No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.

The guidance includes some recommendations for specific osteoporosis medications.

• Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.
• Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.
• Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.
• Teriparatide and abaloparatide should be continued.
• Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.
• Raloxifene should be continued in patients receiving COVID-19 vaccination.

Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

Dr. Jan De Beur has no relevant financial disclosures.

COVID-19 vaccines are safe and effective for patients taking osteoporosis medications, according to joint guidance from six endocrine and osteoporosis societies and foundations.

They noted, though, that some timing modifications with certain medications should be considered to help distinguish between adverse events from the medication versus the vaccine.

The American Society for Bone and Mineral Research “is an international organization, so we brought together our sister societies that have a vested interested in bone health. Vaccination is happening worldwide, and we wanted to present a united front and united recommendations about how to handle osteoporosis medications appropriately during vaccination,” said Suzanne Jan De Beur, MD, who is president of ASBMR and an associate professor of medicine at Johns Hopkins University, Baltimore.

There has been quite a lot of concern from the community about vaccine and medications, from both physicians and patients wondering whether treatments and vaccines should occur in a certain order, and whether there should be a time gap between the two, said Dr. Jan De Beur. “There was a dearth of information about the best practices for osteoporosis treatment management during vaccination, and we didn’t want people missing their opportunity for a vaccine, and we also didn’t want them unnecessarily delaying their osteoporosis treatment.”

There is no evidence that osteoporosis therapies affect the risk or severity of COVID-19 disease, nor do they appear to change the disease course. Osteoporosis itself does not appear associated with increased risk of infection or severe outcomes, so patients with osteoporosis do not need to be prioritized for vaccination based on that condition alone.

There is no evidence that osteoporosis therapies affect the safety or efficacy of vaccination, but given that vaccine availability is currently inconsistent, patients may need to make temporary changes to their osteoporosis regimens to ensure they can receive vaccine when it is available, such as ensuring a delay between medication and vaccination injections.

A key reason for a delay between injectable or infusion medications and a vaccine is to distinguish between adverse events that could occur, so that an adverse reaction to vaccine isn’t mistaken for an adverse reaction to a drug. Nevertheless, the real world is messy. Dr. Jan De Beur noted a recent patient who arrived at her clinic for an injectable treatment who had just received a COVID-19 vaccination that morning. “We decided to put the injection in the other arm, rather than reschedule the person and put them through the risk of coming back. We could distinguish between injection-site reactions, at least,” she said.

copyright DesignPics/Thinkstock

No changes should be made to general bone health therapies, such as calcium and vitamin D supplementation, weight-bearing exercises, and maintenance of a balanced diet.

The guidance includes some recommendations for specific osteoporosis medications.

• Oral bisphosphonates: Alendronate, risedronate, and ibandronate should be continued.
• Intravenous bisphosphonates: a 7-day interval (4-day minimum) is recommended between intravenous bisphosphonate (zoledronic acid and ibandronate) infusion and COVID-19 vaccination in order to distinguish potential autoimmune or inflammatory reactions that could be attributable to either intravenous bisphosphonate or the vaccine.
• Denosumab: There should be a 4- to 7-day delay between denosumab infusion and COVID-19 vaccination to account for injection-site reactions. Another option is to have denosumab injected into the contralateral arm or another site like the abdomen or upper thigh, if spacing the injections is not possible. In any case, denosumab injections should be performed within 7 months of the previous dose.
• Teriparatide and abaloparatide should be continued.
• Romosozumab: There should be a 4- to 7-day delay between a romosozumab injection and COVID-19 vaccine, or romosozumab can be injected in the abdomen (with the exception of a 2-inch area around the naval) or thigh if spacing is not possible.
• Raloxifene should be continued in patients receiving COVID-19 vaccination.

Guidance signatories include ASBMR, the American Association of Clinical Endocrinology, the Endocrine Society, the European Calcified Tissue Society, the National Osteoporosis Foundation, and the International Osteoporosis Foundation.

Dr. Jan De Beur has no relevant financial disclosures.

Levels of insulinlike factor 3 (INSL3) drop noticeably in men who have abused anabolic androgenic steroids (AAS), even well after stoppage. The results suggest that the effects of AAS use on testosterone-producing Leydig cells may be long-lasting, as some clinicians have suspected. Although there is some variation of INSL3 levels among AAS users, the metric is more accurate than testosterone levels and could be a key element of future diagnostic tests.

Those are the conclusions of a new study, led by Jon Jarløv Rasmussen, MD, PhD, of the department of endocrinology at Rigshospitalet in Copenhagen*, published March 9, 2021, in the Journal of Clinical Endocrinology & Metabolism.  

Results mirror clinical experience  

The drop in levels, both among current and past users, is in keeping with clinical experience of endocrinologists, according to Channa Jayasena, MD, PhD, a reproductive endocrinologist at Imperial College London. He suspects lasting damage in former and current users who come to him when they discover their sperm count is low. "How long that damage lasts is another matter," Dr. Jayasena, who was not involved in the study, said in an interview.   

In search of a reliable measure  

Low testosterone levels have been shown to be associated with AAS use in some studies, but not in others. That inconsistency led the researchers in search of a more reliable measure. "Serum testosterone is not a stable marker but can fluctuate considerably within minutes to hours, whereas serum insulinlike factor 3 [levels] do not," said Dr. Rasmussen.  
INSL3 appears to be involved in bone metabolism regulation as well as spermatogenesis.  

Dr. Rasmussen agreed that INSL3 levels could be clinically useful for tracking Leydig cell function, especially in combination with other hormone markers like serum testosterone and gonadotropins. The group is now considering a clinical trial for treatment of hypogonadal men following illicit use of anabolic steroids, which will include INSL3 serum levels as a planned endpoint.  

The researchers conducted a cross-sectional study of men aged 18-50 years who had participated in recreational strength training. Cohort 1 included 37 AAS users, 33 former users, and 30 never users. Cohort 2 included 9 current users, 9 former users, and 14 never users. They assigned participant AAS use status based on self-reporting, along with measurement of biomedical parameters including gonadotropins, sexual hormone-binding globulin (SHBG), and hematocrit.  
Compared with never users' median value of 0.59 mcg/L, INSL3 serum levels were lower among current AAS (median, 0.04 mcg/L; P < .001) and former AAS (0.39 mcg/L; P = .005) users. A linear multivariate regression that adjusted for luteinizing hormone, SHBG, age, body-fat percentage, smoking status, use of other illicit drugs found lower levels among former users, compared with never users (mean difference, -0.16 mcg/L; P = .011). 

An analysis of elapsed duration since AAS cessation found longer duration of AAS use was associated with reduced INSL3 levels (mean difference, -0.08; P = .022). 

Although serum inhibin B levels reached the levels of never users after about 21 months, and luteinizing hormone levels recovered in about 12 months, neither serum testosterone nor INSL3 levels recovered in former users. 

The study authors received funding from Anti Doping Denmark. Dr. Jayasena has no relevant financial disclosures. 

*Dr. Rasmussen's affiliation has been corrected.

Levels of insulinlike factor 3 (INSL3) drop noticeably in men who have abused anabolic androgenic steroids (AAS), even well after stoppage. The results suggest that the effects of AAS use on testosterone-producing Leydig cells may be long-lasting, as some clinicians have suspected. Although there is some variation of INSL3 levels among AAS users, the metric is more accurate than testosterone levels and could be a key element of future diagnostic tests.

Those are the conclusions of a new study, led by Jon Jarløv Rasmussen, MD, PhD, of the department of endocrinology at Rigshospitalet in Copenhagen*, published March 9, 2021, in the Journal of Clinical Endocrinology & Metabolism.  

Results mirror clinical experience  

The drop in levels, both among current and past users, is in keeping with clinical experience of endocrinologists, according to Channa Jayasena, MD, PhD, a reproductive endocrinologist at Imperial College London. He suspects lasting damage in former and current users who come to him when they discover their sperm count is low. "How long that damage lasts is another matter," Dr. Jayasena, who was not involved in the study, said in an interview.   

In search of a reliable measure  

Low testosterone levels have been shown to be associated with AAS use in some studies, but not in others. That inconsistency led the researchers in search of a more reliable measure. "Serum testosterone is not a stable marker but can fluctuate considerably within minutes to hours, whereas serum insulinlike factor 3 [levels] do not," said Dr. Rasmussen.  
INSL3 appears to be involved in bone metabolism regulation as well as spermatogenesis.  

Dr. Rasmussen agreed that INSL3 levels could be clinically useful for tracking Leydig cell function, especially in combination with other hormone markers like serum testosterone and gonadotropins. The group is now considering a clinical trial for treatment of hypogonadal men following illicit use of anabolic steroids, which will include INSL3 serum levels as a planned endpoint.  

The researchers conducted a cross-sectional study of men aged 18-50 years who had participated in recreational strength training. Cohort 1 included 37 AAS users, 33 former users, and 30 never users. Cohort 2 included 9 current users, 9 former users, and 14 never users. They assigned participant AAS use status based on self-reporting, along with measurement of biomedical parameters including gonadotropins, sexual hormone-binding globulin (SHBG), and hematocrit.  
Compared with never users' median value of 0.59 mcg/L, INSL3 serum levels were lower among current AAS (median, 0.04 mcg/L; P < .001) and former AAS (0.39 mcg/L; P = .005) users. A linear multivariate regression that adjusted for luteinizing hormone, SHBG, age, body-fat percentage, smoking status, use of other illicit drugs found lower levels among former users, compared with never users (mean difference, -0.16 mcg/L; P = .011). 

An analysis of elapsed duration since AAS cessation found longer duration of AAS use was associated with reduced INSL3 levels (mean difference, -0.08; P = .022). 

Although serum inhibin B levels reached the levels of never users after about 21 months, and luteinizing hormone levels recovered in about 12 months, neither serum testosterone nor INSL3 levels recovered in former users. 

The study authors received funding from Anti Doping Denmark. Dr. Jayasena has no relevant financial disclosures. 

*Dr. Rasmussen's affiliation has been corrected.

Levels of insulinlike factor 3 (INSL3) drop noticeably in men who have abused anabolic androgenic steroids (AAS), even well after stoppage. The results suggest that the effects of AAS use on testosterone-producing Leydig cells may be long-lasting, as some clinicians have suspected. Although there is some variation of INSL3 levels among AAS users, the metric is more accurate than testosterone levels and could be a key element of future diagnostic tests.

Those are the conclusions of a new study, led by Jon Jarløv Rasmussen, MD, PhD, of the department of endocrinology at Rigshospitalet in Copenhagen*, published March 9, 2021, in the Journal of Clinical Endocrinology & Metabolism.  

Results mirror clinical experience  

The drop in levels, both among current and past users, is in keeping with clinical experience of endocrinologists, according to Channa Jayasena, MD, PhD, a reproductive endocrinologist at Imperial College London. He suspects lasting damage in former and current users who come to him when they discover their sperm count is low. "How long that damage lasts is another matter," Dr. Jayasena, who was not involved in the study, said in an interview.   

In search of a reliable measure  

Low testosterone levels have been shown to be associated with AAS use in some studies, but not in others. That inconsistency led the researchers in search of a more reliable measure. "Serum testosterone is not a stable marker but can fluctuate considerably within minutes to hours, whereas serum insulinlike factor 3 [levels] do not," said Dr. Rasmussen.  
INSL3 appears to be involved in bone metabolism regulation as well as spermatogenesis.  

Dr. Rasmussen agreed that INSL3 levels could be clinically useful for tracking Leydig cell function, especially in combination with other hormone markers like serum testosterone and gonadotropins. The group is now considering a clinical trial for treatment of hypogonadal men following illicit use of anabolic steroids, which will include INSL3 serum levels as a planned endpoint.  

The researchers conducted a cross-sectional study of men aged 18-50 years who had participated in recreational strength training. Cohort 1 included 37 AAS users, 33 former users, and 30 never users. Cohort 2 included 9 current users, 9 former users, and 14 never users. They assigned participant AAS use status based on self-reporting, along with measurement of biomedical parameters including gonadotropins, sexual hormone-binding globulin (SHBG), and hematocrit.  
Compared with never users' median value of 0.59 mcg/L, INSL3 serum levels were lower among current AAS (median, 0.04 mcg/L; P < .001) and former AAS (0.39 mcg/L; P = .005) users. A linear multivariate regression that adjusted for luteinizing hormone, SHBG, age, body-fat percentage, smoking status, use of other illicit drugs found lower levels among former users, compared with never users (mean difference, -0.16 mcg/L; P = .011). 

An analysis of elapsed duration since AAS cessation found longer duration of AAS use was associated with reduced INSL3 levels (mean difference, -0.08; P = .022). 

Although serum inhibin B levels reached the levels of never users after about 21 months, and luteinizing hormone levels recovered in about 12 months, neither serum testosterone nor INSL3 levels recovered in former users. 

The study authors received funding from Anti Doping Denmark. Dr. Jayasena has no relevant financial disclosures. 

*Dr. Rasmussen's affiliation has been corrected.

Cigarette smoking may be associated with a higher probability of developing colorectal neoplasia (CRN) among patients with inflammatory bowel disease (IBD), a finding that if confirmed could help to refine colorectal cancer surveillance guidelines. IBD patients undergo surveillance at specific time points of their disease with the aim to detect and potentially treat early CRN.

Terroa/iStock/Getty Images

But these procedures are costly and burdensome to patients, and some previous studies have revealed a relatively low utility for patients, according to Kimberley van der Sloot, MD, a PhD candidate at the University Medical Center Groningen (the Netherlands). She presented the research at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. The study was also published in Clinical Gastroenterology and Hepatology.

“We aimed to explore the role of cigarette exposure in colorectal neoplasia risk in patients with IBD, and we aimed to improve the CRN risk stratification model that we are currently using for these surveillance guidelines,” Dr. van der Sloot said during her talk.

Commenters during the Q&A period noted that the population database used in the study did not include measures of inflammation, which is a known risk for CRN. One review found that smoking worsens inflammation in Crohn’s disease but improves it in ulcerative colitis.

“It certainly raises the issue that we’ve always said, which is that people should quit smoking for other health reasons, but it doesn’t necessarily answer the question definitively,” said David Rubin, MD, who moderated the session and is professor of medicine at the University of Chicago and chair of the congress’s organizing committee. He added that the association between smoking and CRN risk may nevertheless inform future management surveillance guidelines if it is confirmed.

The researchers analyzed data from the 1000IBD cohort, which is prospectively following IBD patients in the Netherlands. The study included 1,386 patients who had at least one colorectal biopsy. Compared to a general population CRN incidence of 2.4%, Crohn’s disease patients who were never smokers had an incidence of 4.7% versus 10.3% among former or current smokers. In ulcerative colitis, the incidence was 12.5% among never smokers and 17.9% among former or current smokers.

In Crohn’s disease, previous or current smokers had about a twofold increased risk (hazard ratio, 2.04; P = .044). Compared to never smokers, former smokers trended toward an increased risk (HR, 2.16; P = .051), and active smokers had a significantly increased risk (HR, 2.20; P = .044). Passive smoke exposure was also associated with greater risk, both in childhood (HR, 4.79; P = .003) and current (HR, 1.87; P = .024).

In ulcerative colitis, the only statistically significant association between smoke exposure and CRN risk was among former smokers (HR, 1.73; P = .032).

The researchers also looked at patients with a disease duration longer than 8 years and stratified patients according to low risk (left-side ulcerative colitis, <50% of colon affected in Crohn’s disease; n = 425), medium risk (postinflammatory polyposis present or extensive colitis; n = 467), and high risk (concordant primary sclerosing cholangitis or having a first-degree relative with colorectal cancer; n = 143). In Crohn’s disease, current smoking was associated with greater CRN incidence (P = .046), and former smoking trended in that direction but was nonsignificant (P = .068). Former smoking also trended toward a risk in ulcerative colitis (P = .068), but there was no sign of an association for current smoking (P = .883).

In Crohn’s disease, after adjustment for risk stratification, greater CRN risk was associated with passive smoke exposure both during childhood (P = .001) and at present (P = .003).

“We believe this is the first study to describe the important role of cigarette smoking in development of colorectal neoplasia in IBD patients in a large, prospective, cohort, and I think [it] has shown the importance of lifestyle and smoking particularly in IBD. This is one more example. Alongside that, we’ve shown that adding this risk factor can improve the current risk stratification that is used for surveillance guidelines, and might be of benefit in the development of future guidelines,” said Dr. van der Sloot.

Dr. van der Sloot and Dr. Rubin had no relevant financial disclosures.

This article was updated Mar. 11, 2021.

Cigarette smoking may be associated with a higher probability of developing colorectal neoplasia (CRN) among patients with inflammatory bowel disease (IBD), a finding that if confirmed could help to refine colorectal cancer surveillance guidelines. IBD patients undergo surveillance at specific time points of their disease with the aim to detect and potentially treat early CRN.

Terroa/iStock/Getty Images

But these procedures are costly and burdensome to patients, and some previous studies have revealed a relatively low utility for patients, according to Kimberley van der Sloot, MD, a PhD candidate at the University Medical Center Groningen (the Netherlands). She presented the research at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. The study was also published in Clinical Gastroenterology and Hepatology.

“We aimed to explore the role of cigarette exposure in colorectal neoplasia risk in patients with IBD, and we aimed to improve the CRN risk stratification model that we are currently using for these surveillance guidelines,” Dr. van der Sloot said during her talk.

Commenters during the Q&A period noted that the population database used in the study did not include measures of inflammation, which is a known risk for CRN. One review found that smoking worsens inflammation in Crohn’s disease but improves it in ulcerative colitis.

“It certainly raises the issue that we’ve always said, which is that people should quit smoking for other health reasons, but it doesn’t necessarily answer the question definitively,” said David Rubin, MD, who moderated the session and is professor of medicine at the University of Chicago and chair of the congress’s organizing committee. He added that the association between smoking and CRN risk may nevertheless inform future management surveillance guidelines if it is confirmed.

The researchers analyzed data from the 1000IBD cohort, which is prospectively following IBD patients in the Netherlands. The study included 1,386 patients who had at least one colorectal biopsy. Compared to a general population CRN incidence of 2.4%, Crohn’s disease patients who were never smokers had an incidence of 4.7% versus 10.3% among former or current smokers. In ulcerative colitis, the incidence was 12.5% among never smokers and 17.9% among former or current smokers.

In Crohn’s disease, previous or current smokers had about a twofold increased risk (hazard ratio, 2.04; P = .044). Compared to never smokers, former smokers trended toward an increased risk (HR, 2.16; P = .051), and active smokers had a significantly increased risk (HR, 2.20; P = .044). Passive smoke exposure was also associated with greater risk, both in childhood (HR, 4.79; P = .003) and current (HR, 1.87; P = .024).

In ulcerative colitis, the only statistically significant association between smoke exposure and CRN risk was among former smokers (HR, 1.73; P = .032).

The researchers also looked at patients with a disease duration longer than 8 years and stratified patients according to low risk (left-side ulcerative colitis, <50% of colon affected in Crohn’s disease; n = 425), medium risk (postinflammatory polyposis present or extensive colitis; n = 467), and high risk (concordant primary sclerosing cholangitis or having a first-degree relative with colorectal cancer; n = 143). In Crohn’s disease, current smoking was associated with greater CRN incidence (P = .046), and former smoking trended in that direction but was nonsignificant (P = .068). Former smoking also trended toward a risk in ulcerative colitis (P = .068), but there was no sign of an association for current smoking (P = .883).

In Crohn’s disease, after adjustment for risk stratification, greater CRN risk was associated with passive smoke exposure both during childhood (P = .001) and at present (P = .003).

“We believe this is the first study to describe the important role of cigarette smoking in development of colorectal neoplasia in IBD patients in a large, prospective, cohort, and I think [it] has shown the importance of lifestyle and smoking particularly in IBD. This is one more example. Alongside that, we’ve shown that adding this risk factor can improve the current risk stratification that is used for surveillance guidelines, and might be of benefit in the development of future guidelines,” said Dr. van der Sloot.

Dr. van der Sloot and Dr. Rubin had no relevant financial disclosures.

This article was updated Mar. 11, 2021.

Cigarette smoking may be associated with a higher probability of developing colorectal neoplasia (CRN) among patients with inflammatory bowel disease (IBD), a finding that if confirmed could help to refine colorectal cancer surveillance guidelines. IBD patients undergo surveillance at specific time points of their disease with the aim to detect and potentially treat early CRN.

Terroa/iStock/Getty Images

But these procedures are costly and burdensome to patients, and some previous studies have revealed a relatively low utility for patients, according to Kimberley van der Sloot, MD, a PhD candidate at the University Medical Center Groningen (the Netherlands). She presented the research at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. The study was also published in Clinical Gastroenterology and Hepatology.

“We aimed to explore the role of cigarette exposure in colorectal neoplasia risk in patients with IBD, and we aimed to improve the CRN risk stratification model that we are currently using for these surveillance guidelines,” Dr. van der Sloot said during her talk.

Commenters during the Q&A period noted that the population database used in the study did not include measures of inflammation, which is a known risk for CRN. One review found that smoking worsens inflammation in Crohn’s disease but improves it in ulcerative colitis.

“It certainly raises the issue that we’ve always said, which is that people should quit smoking for other health reasons, but it doesn’t necessarily answer the question definitively,” said David Rubin, MD, who moderated the session and is professor of medicine at the University of Chicago and chair of the congress’s organizing committee. He added that the association between smoking and CRN risk may nevertheless inform future management surveillance guidelines if it is confirmed.

The researchers analyzed data from the 1000IBD cohort, which is prospectively following IBD patients in the Netherlands. The study included 1,386 patients who had at least one colorectal biopsy. Compared to a general population CRN incidence of 2.4%, Crohn’s disease patients who were never smokers had an incidence of 4.7% versus 10.3% among former or current smokers. In ulcerative colitis, the incidence was 12.5% among never smokers and 17.9% among former or current smokers.

In Crohn’s disease, previous or current smokers had about a twofold increased risk (hazard ratio, 2.04; P = .044). Compared to never smokers, former smokers trended toward an increased risk (HR, 2.16; P = .051), and active smokers had a significantly increased risk (HR, 2.20; P = .044). Passive smoke exposure was also associated with greater risk, both in childhood (HR, 4.79; P = .003) and current (HR, 1.87; P = .024).

In ulcerative colitis, the only statistically significant association between smoke exposure and CRN risk was among former smokers (HR, 1.73; P = .032).

The researchers also looked at patients with a disease duration longer than 8 years and stratified patients according to low risk (left-side ulcerative colitis, <50% of colon affected in Crohn’s disease; n = 425), medium risk (postinflammatory polyposis present or extensive colitis; n = 467), and high risk (concordant primary sclerosing cholangitis or having a first-degree relative with colorectal cancer; n = 143). In Crohn’s disease, current smoking was associated with greater CRN incidence (P = .046), and former smoking trended in that direction but was nonsignificant (P = .068). Former smoking also trended toward a risk in ulcerative colitis (P = .068), but there was no sign of an association for current smoking (P = .883).

In Crohn’s disease, after adjustment for risk stratification, greater CRN risk was associated with passive smoke exposure both during childhood (P = .001) and at present (P = .003).

“We believe this is the first study to describe the important role of cigarette smoking in development of colorectal neoplasia in IBD patients in a large, prospective, cohort, and I think [it] has shown the importance of lifestyle and smoking particularly in IBD. This is one more example. Alongside that, we’ve shown that adding this risk factor can improve the current risk stratification that is used for surveillance guidelines, and might be of benefit in the development of future guidelines,” said Dr. van der Sloot.

Dr. van der Sloot and Dr. Rubin had no relevant financial disclosures.

This article was updated Mar. 11, 2021.

A new analysis of 11 phase 3/4 cardiovascular clinical trials conducted by the Thrombolysis in Myocardial Infarction (TIMI) group shows that women are more likely than men to discontinue study medications, and to withdraw from trials. The differences could not be explained by different frequencies of reporting adverse events, or by baseline differences.

©BananaStock/thinkstockphotos.com

The findings are significant, since cardiovascular drugs are routinely prescribed to women based on clinical trials that are populated largely by men, according to lead study author Emily Lau, MD, who is an advanced cardiology fellow at Massachusetts General Hospital, Boston. “It highlights an important disparity in clinical research in cardiology, because if women are already not represented well in clinical trials, and if once in clinical trials they don’t complete the study, it’s very hard to extrapolate the clinical trial findings to our female population in an accurate way,” Dr. Lau said in an interview. She also noted that sex-specific and reproductive factors are increasingly recognized as being important in the development and progression of cardiovascular disease.

A new analysis of 11 phase 3/4 cardiovascular clinical trials conducted by the Thrombolysis in Myocardial Infarction (TIMI) group shows that women are more likely than men to discontinue study medications, and to withdraw from trials. The differences could not be explained by different frequencies of reporting adverse events, or by baseline differences.

©BananaStock/thinkstockphotos.com

The findings are significant, since cardiovascular drugs are routinely prescribed to women based on clinical trials that are populated largely by men, according to lead study author Emily Lau, MD, who is an advanced cardiology fellow at Massachusetts General Hospital, Boston. “It highlights an important disparity in clinical research in cardiology, because if women are already not represented well in clinical trials, and if once in clinical trials they don’t complete the study, it’s very hard to extrapolate the clinical trial findings to our female population in an accurate way,” Dr. Lau said in an interview. She also noted that sex-specific and reproductive factors are increasingly recognized as being important in the development and progression of cardiovascular disease.

A new analysis of 11 phase 3/4 cardiovascular clinical trials conducted by the Thrombolysis in Myocardial Infarction (TIMI) group shows that women are more likely than men to discontinue study medications, and to withdraw from trials. The differences could not be explained by different frequencies of reporting adverse events, or by baseline differences.

©BananaStock/thinkstockphotos.com

The findings are significant, since cardiovascular drugs are routinely prescribed to women based on clinical trials that are populated largely by men, according to lead study author Emily Lau, MD, who is an advanced cardiology fellow at Massachusetts General Hospital, Boston. “It highlights an important disparity in clinical research in cardiology, because if women are already not represented well in clinical trials, and if once in clinical trials they don’t complete the study, it’s very hard to extrapolate the clinical trial findings to our female population in an accurate way,” Dr. Lau said in an interview. She also noted that sex-specific and reproductive factors are increasingly recognized as being important in the development and progression of cardiovascular disease.

Patients with cluster headache face a double whammy: Physicians too often fail to recognize it, and their condition is among the most severe and debilitating among headache types. In fact, a new survey of patients with cluster headache shows that they rank the pain as worse than most other painful experiences in life, including childbirth, passing of kidney stones, and pancreatitis, among others.

The study’s comparison of cluster headaches to other common painful experiences can help nonsufferers relate to the experience, said Larry Schor, PhD, a coauthor of the paper. “Headache is a terrible word. Bee stings sting, burns burn. [A cluster headache] doesn’t ache. It’s a piercing intensity like you just can’t believe,” said Dr. Schor, professor of psychology at the University of West Georgia, Carrollton, and a cluster headache patient since he first experienced an attack at the age of 21.

The study was published in the January 2021 issue of Headache.

Ranking cluster headaches as worse than experiences such as childbirth or kidney stones is “kind of eye opening, and helps to describe the experience in terms that more people can relate to. I think it helps to share the experience of cluster headache more broadly, because we’re in a situation where cluster headache remains underfunded, and we don’t have enough treatments for it. I think one way to overcome that is to spread awareness of what this problem is, and the impact it has on human life,” said Rashmi Halker Singh, MD, associate professor of neurology at the Mayo Clinic in Scottsdale, Ariz., and deputy editor of Headache. She was not involved in the study.

Dr. Schor called for physicians to consider cluster headache an emergency, because of the severity of pain and also the potential for suicidality. Treatments remain comparatively sparse, but high-flow oxygen can help some patients, and intranasal or intravenous triptans can treat acute pain. In 2018, the Food and Drug Administration approved galcanezumab (Eli Lilly) for prevention of episodic cluster headaches.

But cluster headaches are often misdiagnosed. For many patients, it takes more than a year or even as long as 5 years to get an accurate diagnosis, according to Dr. Schor. Women may be particularly vulnerable to misdiagnosis, because migraines are more common in women. It doesn’t help that many neurologists are taught that cluster headache is primarily a male disease. “Because that idea is so ingrained, I think a lot of women who have cluster headache are probably missed and told they have migraine instead. There are a lot of women who have cluster headache, and that gender difference might not be as big a difference as we were initially taught. We need to do a better job of recognizing cluster headache to better understand what the true prevalence is,” said Dr. Halker Singh.

She noted that patients with side-locked headache should be evaluated for cluster headache, and asked how long the pain lasts in the absence of medication. “Also ask about the presence of cranial autonomic symptoms, and if they occur in the context of headache pain, and if they are side-locked to the side of the headache. Those are important questions that can tease out cluster headache from other conditions,” said Dr. Halker Singh.

For the survey, the researchers asked 1,604 patients with cluster headache patients to rate pain on a scale of 1 to 10. Cluster headache ranked highest at 9.7, then labor pain (7.2), pancreatitis (7.0), and nephrolithiasis (6.9). Cluster headache pain was ranked at 10.0 by 72.1% of respondents. Those reporting maximal pain or were more likely to have cranial autonomic features in comparison with patients who reported less pain, including conjunctival injection or lacrimation (91% versus 85%), eyelid edema (77% versus 66%), forehead/facial sweating (60% versus 49%), fullness in the ear (47% versus 35%), and miosis or ptosis (85% versus 75%). They had more frequent attacks (4.0 versus 3.5 per day), higher Hopelessness Depression Symptom Questionnaire scores (24.5 versus 21.1), and reduced effectiveness of calcium channel blockers (2.2 versus 2.5 on a 5-point Likert scale). They were more often female (34% versus 24%). (P < .001 for all).

The study received funding from Autonomic Technologies and Cluster Busters. Dr. Schor and Dr. Halker Singh had no relevant financial disclosures.

Patients with cluster headache face a double whammy: Physicians too often fail to recognize it, and their condition is among the most severe and debilitating among headache types. In fact, a new survey of patients with cluster headache shows that they rank the pain as worse than most other painful experiences in life, including childbirth, passing of kidney stones, and pancreatitis, among others.

The study’s comparison of cluster headaches to other common painful experiences can help nonsufferers relate to the experience, said Larry Schor, PhD, a coauthor of the paper. “Headache is a terrible word. Bee stings sting, burns burn. [A cluster headache] doesn’t ache. It’s a piercing intensity like you just can’t believe,” said Dr. Schor, professor of psychology at the University of West Georgia, Carrollton, and a cluster headache patient since he first experienced an attack at the age of 21.

The study was published in the January 2021 issue of Headache.

Ranking cluster headaches as worse than experiences such as childbirth or kidney stones is “kind of eye opening, and helps to describe the experience in terms that more people can relate to. I think it helps to share the experience of cluster headache more broadly, because we’re in a situation where cluster headache remains underfunded, and we don’t have enough treatments for it. I think one way to overcome that is to spread awareness of what this problem is, and the impact it has on human life,” said Rashmi Halker Singh, MD, associate professor of neurology at the Mayo Clinic in Scottsdale, Ariz., and deputy editor of Headache. She was not involved in the study.

Dr. Schor called for physicians to consider cluster headache an emergency, because of the severity of pain and also the potential for suicidality. Treatments remain comparatively sparse, but high-flow oxygen can help some patients, and intranasal or intravenous triptans can treat acute pain. In 2018, the Food and Drug Administration approved galcanezumab (Eli Lilly) for prevention of episodic cluster headaches.

But cluster headaches are often misdiagnosed. For many patients, it takes more than a year or even as long as 5 years to get an accurate diagnosis, according to Dr. Schor. Women may be particularly vulnerable to misdiagnosis, because migraines are more common in women. It doesn’t help that many neurologists are taught that cluster headache is primarily a male disease. “Because that idea is so ingrained, I think a lot of women who have cluster headache are probably missed and told they have migraine instead. There are a lot of women who have cluster headache, and that gender difference might not be as big a difference as we were initially taught. We need to do a better job of recognizing cluster headache to better understand what the true prevalence is,” said Dr. Halker Singh.

She noted that patients with side-locked headache should be evaluated for cluster headache, and asked how long the pain lasts in the absence of medication. “Also ask about the presence of cranial autonomic symptoms, and if they occur in the context of headache pain, and if they are side-locked to the side of the headache. Those are important questions that can tease out cluster headache from other conditions,” said Dr. Halker Singh.

For the survey, the researchers asked 1,604 patients with cluster headache patients to rate pain on a scale of 1 to 10. Cluster headache ranked highest at 9.7, then labor pain (7.2), pancreatitis (7.0), and nephrolithiasis (6.9). Cluster headache pain was ranked at 10.0 by 72.1% of respondents. Those reporting maximal pain or were more likely to have cranial autonomic features in comparison with patients who reported less pain, including conjunctival injection or lacrimation (91% versus 85%), eyelid edema (77% versus 66%), forehead/facial sweating (60% versus 49%), fullness in the ear (47% versus 35%), and miosis or ptosis (85% versus 75%). They had more frequent attacks (4.0 versus 3.5 per day), higher Hopelessness Depression Symptom Questionnaire scores (24.5 versus 21.1), and reduced effectiveness of calcium channel blockers (2.2 versus 2.5 on a 5-point Likert scale). They were more often female (34% versus 24%). (P < .001 for all).

The study received funding from Autonomic Technologies and Cluster Busters. Dr. Schor and Dr. Halker Singh had no relevant financial disclosures.

Patients with cluster headache face a double whammy: Physicians too often fail to recognize it, and their condition is among the most severe and debilitating among headache types. In fact, a new survey of patients with cluster headache shows that they rank the pain as worse than most other painful experiences in life, including childbirth, passing of kidney stones, and pancreatitis, among others.

The study’s comparison of cluster headaches to other common painful experiences can help nonsufferers relate to the experience, said Larry Schor, PhD, a coauthor of the paper. “Headache is a terrible word. Bee stings sting, burns burn. [A cluster headache] doesn’t ache. It’s a piercing intensity like you just can’t believe,” said Dr. Schor, professor of psychology at the University of West Georgia, Carrollton, and a cluster headache patient since he first experienced an attack at the age of 21.

The study was published in the January 2021 issue of Headache.

Ranking cluster headaches as worse than experiences such as childbirth or kidney stones is “kind of eye opening, and helps to describe the experience in terms that more people can relate to. I think it helps to share the experience of cluster headache more broadly, because we’re in a situation where cluster headache remains underfunded, and we don’t have enough treatments for it. I think one way to overcome that is to spread awareness of what this problem is, and the impact it has on human life,” said Rashmi Halker Singh, MD, associate professor of neurology at the Mayo Clinic in Scottsdale, Ariz., and deputy editor of Headache. She was not involved in the study.

Dr. Schor called for physicians to consider cluster headache an emergency, because of the severity of pain and also the potential for suicidality. Treatments remain comparatively sparse, but high-flow oxygen can help some patients, and intranasal or intravenous triptans can treat acute pain. In 2018, the Food and Drug Administration approved galcanezumab (Eli Lilly) for prevention of episodic cluster headaches.

But cluster headaches are often misdiagnosed. For many patients, it takes more than a year or even as long as 5 years to get an accurate diagnosis, according to Dr. Schor. Women may be particularly vulnerable to misdiagnosis, because migraines are more common in women. It doesn’t help that many neurologists are taught that cluster headache is primarily a male disease. “Because that idea is so ingrained, I think a lot of women who have cluster headache are probably missed and told they have migraine instead. There are a lot of women who have cluster headache, and that gender difference might not be as big a difference as we were initially taught. We need to do a better job of recognizing cluster headache to better understand what the true prevalence is,” said Dr. Halker Singh.

She noted that patients with side-locked headache should be evaluated for cluster headache, and asked how long the pain lasts in the absence of medication. “Also ask about the presence of cranial autonomic symptoms, and if they occur in the context of headache pain, and if they are side-locked to the side of the headache. Those are important questions that can tease out cluster headache from other conditions,” said Dr. Halker Singh.

For the survey, the researchers asked 1,604 patients with cluster headache patients to rate pain on a scale of 1 to 10. Cluster headache ranked highest at 9.7, then labor pain (7.2), pancreatitis (7.0), and nephrolithiasis (6.9). Cluster headache pain was ranked at 10.0 by 72.1% of respondents. Those reporting maximal pain or were more likely to have cranial autonomic features in comparison with patients who reported less pain, including conjunctival injection or lacrimation (91% versus 85%), eyelid edema (77% versus 66%), forehead/facial sweating (60% versus 49%), fullness in the ear (47% versus 35%), and miosis or ptosis (85% versus 75%). They had more frequent attacks (4.0 versus 3.5 per day), higher Hopelessness Depression Symptom Questionnaire scores (24.5 versus 21.1), and reduced effectiveness of calcium channel blockers (2.2 versus 2.5 on a 5-point Likert scale). They were more often female (34% versus 24%). (P < .001 for all).

The study received funding from Autonomic Technologies and Cluster Busters. Dr. Schor and Dr. Halker Singh had no relevant financial disclosures.

A large analysis of Medicare data from all 50 states suggests that vedolizumab may be just as effective as anti–tumor necrosis factor (anti-TNF) agents in controlling inflammatory bowel disease (IBD) in patients aged over 65 years, with fewer infectious disease hospitalizations.

The study was prompted by the fact that older adults are greatly underrepresented in clinical trials of approved IBD medications. There is a second peak in IBD diagnosis among people in their 50s and 60s, and IBD patients are living longer with more effective medications. So although a significant number of IBD patients are aged 65 years or older, that group encompasses less than 1% of adults in clinical trials, Bharati Kochar, MD, reported at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“Therefore, we don’t know how well these medications work and how safe they are specifically in older adults,” said Dr. Kochar, a gastroenterologist at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, both in Boston.

The data largely support what had been known mechanistically about vedolizumab. “It suggests that both drugs work well enough to prevent [IBD-related] hospitalizations, but clearly there was a benefit toward the safer medication, Entyvio [vedolizumab], in the infection-related hospitalizations. That’s not the only readout in infections, but it is an important readout because infections that get hospitalized are the ones that predict mortality and disability,” said Matthew Ciorba, MD, who attended the session. Dr. Ciorba is director of the IBD Center at Washington University in St. Louis and was not involved in the study.

“I think this study is reassuring to clinicians. It provides important clinical data that support what we know about the mechanisms of vedolizumab. The safety data we predicted is borne out in this large and well-done study,” said Dr. Ciorba.

A large analysis of Medicare data from all 50 states suggests that vedolizumab may be just as effective as anti–tumor necrosis factor (anti-TNF) agents in controlling inflammatory bowel disease (IBD) in patients aged over 65 years, with fewer infectious disease hospitalizations.

The study was prompted by the fact that older adults are greatly underrepresented in clinical trials of approved IBD medications. There is a second peak in IBD diagnosis among people in their 50s and 60s, and IBD patients are living longer with more effective medications. So although a significant number of IBD patients are aged 65 years or older, that group encompasses less than 1% of adults in clinical trials, Bharati Kochar, MD, reported at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“Therefore, we don’t know how well these medications work and how safe they are specifically in older adults,” said Dr. Kochar, a gastroenterologist at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, both in Boston.

The data largely support what had been known mechanistically about vedolizumab. “It suggests that both drugs work well enough to prevent [IBD-related] hospitalizations, but clearly there was a benefit toward the safer medication, Entyvio [vedolizumab], in the infection-related hospitalizations. That’s not the only readout in infections, but it is an important readout because infections that get hospitalized are the ones that predict mortality and disability,” said Matthew Ciorba, MD, who attended the session. Dr. Ciorba is director of the IBD Center at Washington University in St. Louis and was not involved in the study.

“I think this study is reassuring to clinicians. It provides important clinical data that support what we know about the mechanisms of vedolizumab. The safety data we predicted is borne out in this large and well-done study,” said Dr. Ciorba.

A large analysis of Medicare data from all 50 states suggests that vedolizumab may be just as effective as anti–tumor necrosis factor (anti-TNF) agents in controlling inflammatory bowel disease (IBD) in patients aged over 65 years, with fewer infectious disease hospitalizations.

The study was prompted by the fact that older adults are greatly underrepresented in clinical trials of approved IBD medications. There is a second peak in IBD diagnosis among people in their 50s and 60s, and IBD patients are living longer with more effective medications. So although a significant number of IBD patients are aged 65 years or older, that group encompasses less than 1% of adults in clinical trials, Bharati Kochar, MD, reported at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“Therefore, we don’t know how well these medications work and how safe they are specifically in older adults,” said Dr. Kochar, a gastroenterologist at Massachusetts General Hospital and assistant professor of medicine at Harvard Medical School, both in Boston.

The data largely support what had been known mechanistically about vedolizumab. “It suggests that both drugs work well enough to prevent [IBD-related] hospitalizations, but clearly there was a benefit toward the safer medication, Entyvio [vedolizumab], in the infection-related hospitalizations. That’s not the only readout in infections, but it is an important readout because infections that get hospitalized are the ones that predict mortality and disability,” said Matthew Ciorba, MD, who attended the session. Dr. Ciorba is director of the IBD Center at Washington University in St. Louis and was not involved in the study.

“I think this study is reassuring to clinicians. It provides important clinical data that support what we know about the mechanisms of vedolizumab. The safety data we predicted is borne out in this large and well-done study,” said Dr. Ciorba.

Physicians treating patients with IBD typically focus on disease and symptom management along with quality of life measures, but the latter are not the final word on patient well-being. Social well-being is another outcome that can more accurately portray a patient’s satisfaction with their treatment.

That was the message delivered by Laurie Keefer, PhD, at a session on diet, stress, health literacy, and disparities in IBD treatment at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “When we talk about disease management, we’re talking about these outcomes of mucosal healing, remission, and lack of hospitalizations, but we don’t always talk about wellness,” said Dr. Keefer, director of psychobehavioral research in the department of gastroenterology at Icahn School of Medicine at Mount Sinai, New York.

Dr. Keefer advocated for incorporating measures that focus on the patient’s ability to feel fulfilled, pursue happiness, and contribute to the community. “Wellness is defined as a state of complete physical, mental, and social well-being. It’s a holistic definition, not merely the absence of those things,” she said during her talk.

Social determinants of health, such as income, inequality, health literacy, numeracy, financial stress, social connections, community, place of resonance, and housing coresidents, play important roles.

“Subjective well-being is a state in which an individual feels they are able to do work productively and creatively, have relationships, and contribute to their community. We want them to thrive. We want them to live well. We want them to reach their potential. There’s no reason you cannot reach your potential even though you’re living with IBD,” said Dr. Keefer.

Subjective well-being doesn’t replace quality of life assessment. “Absolutely, quality of life is an important metric, [but I want to] make a plug that maybe we should start to add subjective well-being into these outcome measures,” said Dr. Keefer.

The approach does away with specific measures of health, employment, financial security, or even living situation. “It takes away all of those things we just assume are part of being well. It measures it differently. It measures what makes us happy, divided by the degree of happiness we obtain,” said Dr. Keefer. She presented examples from a study her group is conducting that showed patients’ responses to what made them want to be well. “Some people want to be well to take care of their children or families or a parent, some people want to be well so they can go adventure skydiving, other people just want to be able to exercise and take care of their health. That’s what the target needs to be for wellness. In that sense, wellness is an achievement of best health possible in all domains, not just one. It’s a lifelong pursuit. It forces us to ask not just ‘Are my patient’s symptoms gone? Are they in clinical remission? Are they in histological remission? Are they in deep remission?’ but ‘Is my patient thriving? Are they meeting their potential? Are they getting what they want out of treatment? Are they happy?’ ”

Quality of life measures can provide some insight, but they are limited because they are anchored in physical symptoms, and they focus on a narrow, recent window, usually the past week. “You can imagine that as symptoms improve, those metrics kind of improve, and it looks like quality of life is great. But that’s not always the case, and we’re really missing an opportunity to go deeper. It’s also less sensitive when somebody is in remission, so it’s also very difficult to continue that proactive [approach] of thriving and living well when you’re already coming up positive on quality of life indices,” said Dr. Keefer.

Subjective well-being measures ignore physical symptoms, and focus instead on questions like the patient’s ability to work, socialize, and maintain relationships with family, and whether the patient feels able to contribute meaningfully to society. The measure is insensitive to factors such as inflammation, trauma, or changes to medication. As a result, measures can be used much less frequently – every 6 months, or even once a year.

Subjective well-being can also rely on the patient to define well-being, and that makes it more culturally sensitive. “It can allow for people to be well in whatever way they think they want to be well,” said Dr. Keefer.

There are various resources for measuring subjective well-being. The Organization for Economic Cooperation and Development has guidelines for measuring subjective well-being. The National Institutes of Health PROMIS includes useful measures of psychological well-being, positive affect, and general life satisfaction; they are available for free and include 6-8 items. Other useful measures include the Satisfaction with Life scale, the Positive and Negative Affect scale, and the Harmony in Life scale. “All of those have been well validated and used internationally as measures of well-being,” said Dr. Keefer.

Physicians can also address patients directly, asking them about how satisfied they are with their life. “You’re opening up that discussion to ask them not just, ‘How is your IBD and how is your IBD affecting your work?’ but ‘How is your life going?’ You’re proactively trying to help your patients thrive,” said Dr. Keefer.

Session moderators praised Dr. Keefer’s presentation as an appropriate wrap-up to talks that looked at stress, diet, economic disparities, health literacy, and numeracy.

“We capped it all with a discussion around what is well-being. We often talk about biologics or medicines or surgery when it comes to Crohn’s disease and ulcerative colitis, but what about holistic wellness? It’s all of this. It’s the medication piece, but it’s all of these other pillars involved in the process as well. I think looking at this from many different angles is very important so that patients can achieve the best quality of life possible,” said comoderator Tina Aswani Omprakash, a patient advocate who is pursuing a master’s degree in public health at Mount Sinai’s Icahn School of Medicine.

Physicians treating patients with IBD typically focus on disease and symptom management along with quality of life measures, but the latter are not the final word on patient well-being. Social well-being is another outcome that can more accurately portray a patient’s satisfaction with their treatment.

That was the message delivered by Laurie Keefer, PhD, at a session on diet, stress, health literacy, and disparities in IBD treatment at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “When we talk about disease management, we’re talking about these outcomes of mucosal healing, remission, and lack of hospitalizations, but we don’t always talk about wellness,” said Dr. Keefer, director of psychobehavioral research in the department of gastroenterology at Icahn School of Medicine at Mount Sinai, New York.

Dr. Keefer advocated for incorporating measures that focus on the patient’s ability to feel fulfilled, pursue happiness, and contribute to the community. “Wellness is defined as a state of complete physical, mental, and social well-being. It’s a holistic definition, not merely the absence of those things,” she said during her talk.

Social determinants of health, such as income, inequality, health literacy, numeracy, financial stress, social connections, community, place of resonance, and housing coresidents, play important roles.

“Subjective well-being is a state in which an individual feels they are able to do work productively and creatively, have relationships, and contribute to their community. We want them to thrive. We want them to live well. We want them to reach their potential. There’s no reason you cannot reach your potential even though you’re living with IBD,” said Dr. Keefer.

Subjective well-being doesn’t replace quality of life assessment. “Absolutely, quality of life is an important metric, [but I want to] make a plug that maybe we should start to add subjective well-being into these outcome measures,” said Dr. Keefer.

The approach does away with specific measures of health, employment, financial security, or even living situation. “It takes away all of those things we just assume are part of being well. It measures it differently. It measures what makes us happy, divided by the degree of happiness we obtain,” said Dr. Keefer. She presented examples from a study her group is conducting that showed patients’ responses to what made them want to be well. “Some people want to be well to take care of their children or families or a parent, some people want to be well so they can go adventure skydiving, other people just want to be able to exercise and take care of their health. That’s what the target needs to be for wellness. In that sense, wellness is an achievement of best health possible in all domains, not just one. It’s a lifelong pursuit. It forces us to ask not just ‘Are my patient’s symptoms gone? Are they in clinical remission? Are they in histological remission? Are they in deep remission?’ but ‘Is my patient thriving? Are they meeting their potential? Are they getting what they want out of treatment? Are they happy?’ ”

Quality of life measures can provide some insight, but they are limited because they are anchored in physical symptoms, and they focus on a narrow, recent window, usually the past week. “You can imagine that as symptoms improve, those metrics kind of improve, and it looks like quality of life is great. But that’s not always the case, and we’re really missing an opportunity to go deeper. It’s also less sensitive when somebody is in remission, so it’s also very difficult to continue that proactive [approach] of thriving and living well when you’re already coming up positive on quality of life indices,” said Dr. Keefer.

Subjective well-being measures ignore physical symptoms, and focus instead on questions like the patient’s ability to work, socialize, and maintain relationships with family, and whether the patient feels able to contribute meaningfully to society. The measure is insensitive to factors such as inflammation, trauma, or changes to medication. As a result, measures can be used much less frequently – every 6 months, or even once a year.

Subjective well-being can also rely on the patient to define well-being, and that makes it more culturally sensitive. “It can allow for people to be well in whatever way they think they want to be well,” said Dr. Keefer.

There are various resources for measuring subjective well-being. The Organization for Economic Cooperation and Development has guidelines for measuring subjective well-being. The National Institutes of Health PROMIS includes useful measures of psychological well-being, positive affect, and general life satisfaction; they are available for free and include 6-8 items. Other useful measures include the Satisfaction with Life scale, the Positive and Negative Affect scale, and the Harmony in Life scale. “All of those have been well validated and used internationally as measures of well-being,” said Dr. Keefer.

Physicians can also address patients directly, asking them about how satisfied they are with their life. “You’re opening up that discussion to ask them not just, ‘How is your IBD and how is your IBD affecting your work?’ but ‘How is your life going?’ You’re proactively trying to help your patients thrive,” said Dr. Keefer.

Session moderators praised Dr. Keefer’s presentation as an appropriate wrap-up to talks that looked at stress, diet, economic disparities, health literacy, and numeracy.

“We capped it all with a discussion around what is well-being. We often talk about biologics or medicines or surgery when it comes to Crohn’s disease and ulcerative colitis, but what about holistic wellness? It’s all of this. It’s the medication piece, but it’s all of these other pillars involved in the process as well. I think looking at this from many different angles is very important so that patients can achieve the best quality of life possible,” said comoderator Tina Aswani Omprakash, a patient advocate who is pursuing a master’s degree in public health at Mount Sinai’s Icahn School of Medicine.

Physicians treating patients with IBD typically focus on disease and symptom management along with quality of life measures, but the latter are not the final word on patient well-being. Social well-being is another outcome that can more accurately portray a patient’s satisfaction with their treatment.

That was the message delivered by Laurie Keefer, PhD, at a session on diet, stress, health literacy, and disparities in IBD treatment at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “When we talk about disease management, we’re talking about these outcomes of mucosal healing, remission, and lack of hospitalizations, but we don’t always talk about wellness,” said Dr. Keefer, director of psychobehavioral research in the department of gastroenterology at Icahn School of Medicine at Mount Sinai, New York.

Dr. Keefer advocated for incorporating measures that focus on the patient’s ability to feel fulfilled, pursue happiness, and contribute to the community. “Wellness is defined as a state of complete physical, mental, and social well-being. It’s a holistic definition, not merely the absence of those things,” she said during her talk.

Social determinants of health, such as income, inequality, health literacy, numeracy, financial stress, social connections, community, place of resonance, and housing coresidents, play important roles.

“Subjective well-being is a state in which an individual feels they are able to do work productively and creatively, have relationships, and contribute to their community. We want them to thrive. We want them to live well. We want them to reach their potential. There’s no reason you cannot reach your potential even though you’re living with IBD,” said Dr. Keefer.

Subjective well-being doesn’t replace quality of life assessment. “Absolutely, quality of life is an important metric, [but I want to] make a plug that maybe we should start to add subjective well-being into these outcome measures,” said Dr. Keefer.

The approach does away with specific measures of health, employment, financial security, or even living situation. “It takes away all of those things we just assume are part of being well. It measures it differently. It measures what makes us happy, divided by the degree of happiness we obtain,” said Dr. Keefer. She presented examples from a study her group is conducting that showed patients’ responses to what made them want to be well. “Some people want to be well to take care of their children or families or a parent, some people want to be well so they can go adventure skydiving, other people just want to be able to exercise and take care of their health. That’s what the target needs to be for wellness. In that sense, wellness is an achievement of best health possible in all domains, not just one. It’s a lifelong pursuit. It forces us to ask not just ‘Are my patient’s symptoms gone? Are they in clinical remission? Are they in histological remission? Are they in deep remission?’ but ‘Is my patient thriving? Are they meeting their potential? Are they getting what they want out of treatment? Are they happy?’ ”

Quality of life measures can provide some insight, but they are limited because they are anchored in physical symptoms, and they focus on a narrow, recent window, usually the past week. “You can imagine that as symptoms improve, those metrics kind of improve, and it looks like quality of life is great. But that’s not always the case, and we’re really missing an opportunity to go deeper. It’s also less sensitive when somebody is in remission, so it’s also very difficult to continue that proactive [approach] of thriving and living well when you’re already coming up positive on quality of life indices,” said Dr. Keefer.

Subjective well-being measures ignore physical symptoms, and focus instead on questions like the patient’s ability to work, socialize, and maintain relationships with family, and whether the patient feels able to contribute meaningfully to society. The measure is insensitive to factors such as inflammation, trauma, or changes to medication. As a result, measures can be used much less frequently – every 6 months, or even once a year.

Subjective well-being can also rely on the patient to define well-being, and that makes it more culturally sensitive. “It can allow for people to be well in whatever way they think they want to be well,” said Dr. Keefer.

There are various resources for measuring subjective well-being. The Organization for Economic Cooperation and Development has guidelines for measuring subjective well-being. The National Institutes of Health PROMIS includes useful measures of psychological well-being, positive affect, and general life satisfaction; they are available for free and include 6-8 items. Other useful measures include the Satisfaction with Life scale, the Positive and Negative Affect scale, and the Harmony in Life scale. “All of those have been well validated and used internationally as measures of well-being,” said Dr. Keefer.

Physicians can also address patients directly, asking them about how satisfied they are with their life. “You’re opening up that discussion to ask them not just, ‘How is your IBD and how is your IBD affecting your work?’ but ‘How is your life going?’ You’re proactively trying to help your patients thrive,” said Dr. Keefer.

Session moderators praised Dr. Keefer’s presentation as an appropriate wrap-up to talks that looked at stress, diet, economic disparities, health literacy, and numeracy.

“We capped it all with a discussion around what is well-being. We often talk about biologics or medicines or surgery when it comes to Crohn’s disease and ulcerative colitis, but what about holistic wellness? It’s all of this. It’s the medication piece, but it’s all of these other pillars involved in the process as well. I think looking at this from many different angles is very important so that patients can achieve the best quality of life possible,” said comoderator Tina Aswani Omprakash, a patient advocate who is pursuing a master’s degree in public health at Mount Sinai’s Icahn School of Medicine.

Nonalcoholic fatty liver disease (NAFLD) in patients with inflammatory bowel disease (IBD) is associated with worse outcomes, and that relationship may be influenced by nonmetabolic factors. That is the conclusion of a new nationwide database analysis. NAFLD is common in IBD, with an estimated prevalence of 27%-32%.

Previous, smaller studies showed possible links between NAFLD and a history of IBD surgery, IBD disease activity, and metabolic factors, “but none of the studies looked at it on the scale that we did, and our study was more focused on outcomes than simply examining factors associated with both NAFLD and IBD,” Shaya Noorian, MD, of UCLA Medical Center in Los Angeles, said in an interview. Dr. Noorian presented the research at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Dr. Noorian and colleagues found higher rates of hospital readmission, longer hospitalization, and higher costs, but not higher rates of death among patients with both Crohn’s disease or ulcerative colitis and NAFLD. The researchers analyzed data from patients in the Nationwide Readmissions Database (2016-2017), using ICD-10 codes to identify patients with IBD and NAFLD, along with propensity-matched controls. The study included 3,655 with Crohn’s disease and NAFLD and 7,482 without, and there were 2,026 with ulcerative colitis and NAFLD 4,094 without.

IBD hospital readmission rates were higher with comorbid NAFLD in Crohn’s disease (hazard ratio, 1.98; 95% confidence interval, 1.8-2.17; P < .001) and ulcerative colitis (HR, 1.97; 95% CI, 1.67-2.32; P < .001). Comorbid NAFLD was associated with additional length of stay Crohn’s disease (0.74 days; 95% CI, 0.29-1.18; P < .01) and ulcerative colitis (0.84 days; 0.32-1.35, respectively; P < .01), and there was additional cost of care with both Crohn’s disease ($7,766; 95% CI, $2,693-$12,839; P < .01) and ulcerative colitis ($11,496; 95% CI, $4,361-$18,631; P < .01).

Kaplan Meier curves for IBD readmission-free survival versus days since discharge showed clear separation in both Crohn’s disease and ulcerative colitis among patients with versus those without NAFLD.

Although evidence points to nonmetabolic factors being involved, metabolic factors such as obesity and diabetes are likely important as well. “We still do recognize that it’s very likely that these metabolic factors play a role in developing NAFLD in IBD. I think the fact that there are worse outcomes in patients with NAFLD supports the fact that we should do our best to control the metabolic factors like diabetes, obesity, et cetera. We don’t want to minimize that aspect of it. But I think the fact that there were still worse outcomes after adjusting for metabolic factors emphasizes the importance of researching these factors further to see which ones are the main contributors. If we can find the main contributor, whether that’s medication, IBD disease burden, or history of surgery, perhaps we can use that information to prevent development or progression of NAFLD,” said Dr. Noorian.

“Historical reports have examined the relationship between Crohn’s disease and NAFLD. The currently study included both Crohn’s and ulcerative colitis, thus impressively demonstrating the importance of this interaction across IBD,” said Matthew Ciorba, MD, director of the IBD Center at Washington University in St. Louis, who attended the session.

Nonalcoholic fatty liver disease (NAFLD) in patients with inflammatory bowel disease (IBD) is associated with worse outcomes, and that relationship may be influenced by nonmetabolic factors. That is the conclusion of a new nationwide database analysis. NAFLD is common in IBD, with an estimated prevalence of 27%-32%.

Previous, smaller studies showed possible links between NAFLD and a history of IBD surgery, IBD disease activity, and metabolic factors, “but none of the studies looked at it on the scale that we did, and our study was more focused on outcomes than simply examining factors associated with both NAFLD and IBD,” Shaya Noorian, MD, of UCLA Medical Center in Los Angeles, said in an interview. Dr. Noorian presented the research at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Dr. Noorian and colleagues found higher rates of hospital readmission, longer hospitalization, and higher costs, but not higher rates of death among patients with both Crohn’s disease or ulcerative colitis and NAFLD. The researchers analyzed data from patients in the Nationwide Readmissions Database (2016-2017), using ICD-10 codes to identify patients with IBD and NAFLD, along with propensity-matched controls. The study included 3,655 with Crohn’s disease and NAFLD and 7,482 without, and there were 2,026 with ulcerative colitis and NAFLD 4,094 without.

IBD hospital readmission rates were higher with comorbid NAFLD in Crohn’s disease (hazard ratio, 1.98; 95% confidence interval, 1.8-2.17; P < .001) and ulcerative colitis (HR, 1.97; 95% CI, 1.67-2.32; P < .001). Comorbid NAFLD was associated with additional length of stay Crohn’s disease (0.74 days; 95% CI, 0.29-1.18; P < .01) and ulcerative colitis (0.84 days; 0.32-1.35, respectively; P < .01), and there was additional cost of care with both Crohn’s disease ($7,766; 95% CI, $2,693-$12,839; P < .01) and ulcerative colitis ($11,496; 95% CI, $4,361-$18,631; P < .01).

Kaplan Meier curves for IBD readmission-free survival versus days since discharge showed clear separation in both Crohn’s disease and ulcerative colitis among patients with versus those without NAFLD.

Although evidence points to nonmetabolic factors being involved, metabolic factors such as obesity and diabetes are likely important as well. “We still do recognize that it’s very likely that these metabolic factors play a role in developing NAFLD in IBD. I think the fact that there are worse outcomes in patients with NAFLD supports the fact that we should do our best to control the metabolic factors like diabetes, obesity, et cetera. We don’t want to minimize that aspect of it. But I think the fact that there were still worse outcomes after adjusting for metabolic factors emphasizes the importance of researching these factors further to see which ones are the main contributors. If we can find the main contributor, whether that’s medication, IBD disease burden, or history of surgery, perhaps we can use that information to prevent development or progression of NAFLD,” said Dr. Noorian.

“Historical reports have examined the relationship between Crohn’s disease and NAFLD. The currently study included both Crohn’s and ulcerative colitis, thus impressively demonstrating the importance of this interaction across IBD,” said Matthew Ciorba, MD, director of the IBD Center at Washington University in St. Louis, who attended the session.

Nonalcoholic fatty liver disease (NAFLD) in patients with inflammatory bowel disease (IBD) is associated with worse outcomes, and that relationship may be influenced by nonmetabolic factors. That is the conclusion of a new nationwide database analysis. NAFLD is common in IBD, with an estimated prevalence of 27%-32%.

Previous, smaller studies showed possible links between NAFLD and a history of IBD surgery, IBD disease activity, and metabolic factors, “but none of the studies looked at it on the scale that we did, and our study was more focused on outcomes than simply examining factors associated with both NAFLD and IBD,” Shaya Noorian, MD, of UCLA Medical Center in Los Angeles, said in an interview. Dr. Noorian presented the research at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Dr. Noorian and colleagues found higher rates of hospital readmission, longer hospitalization, and higher costs, but not higher rates of death among patients with both Crohn’s disease or ulcerative colitis and NAFLD. The researchers analyzed data from patients in the Nationwide Readmissions Database (2016-2017), using ICD-10 codes to identify patients with IBD and NAFLD, along with propensity-matched controls. The study included 3,655 with Crohn’s disease and NAFLD and 7,482 without, and there were 2,026 with ulcerative colitis and NAFLD 4,094 without.

IBD hospital readmission rates were higher with comorbid NAFLD in Crohn’s disease (hazard ratio, 1.98; 95% confidence interval, 1.8-2.17; P < .001) and ulcerative colitis (HR, 1.97; 95% CI, 1.67-2.32; P < .001). Comorbid NAFLD was associated with additional length of stay Crohn’s disease (0.74 days; 95% CI, 0.29-1.18; P < .01) and ulcerative colitis (0.84 days; 0.32-1.35, respectively; P < .01), and there was additional cost of care with both Crohn’s disease ($7,766; 95% CI, $2,693-$12,839; P < .01) and ulcerative colitis ($11,496; 95% CI, $4,361-$18,631; P < .01).

Kaplan Meier curves for IBD readmission-free survival versus days since discharge showed clear separation in both Crohn’s disease and ulcerative colitis among patients with versus those without NAFLD.

Although evidence points to nonmetabolic factors being involved, metabolic factors such as obesity and diabetes are likely important as well. “We still do recognize that it’s very likely that these metabolic factors play a role in developing NAFLD in IBD. I think the fact that there are worse outcomes in patients with NAFLD supports the fact that we should do our best to control the metabolic factors like diabetes, obesity, et cetera. We don’t want to minimize that aspect of it. But I think the fact that there were still worse outcomes after adjusting for metabolic factors emphasizes the importance of researching these factors further to see which ones are the main contributors. If we can find the main contributor, whether that’s medication, IBD disease burden, or history of surgery, perhaps we can use that information to prevent development or progression of NAFLD,” said Dr. Noorian.

“Historical reports have examined the relationship between Crohn’s disease and NAFLD. The currently study included both Crohn’s and ulcerative colitis, thus impressively demonstrating the importance of this interaction across IBD,” said Matthew Ciorba, MD, director of the IBD Center at Washington University in St. Louis, who attended the session.

Although inflammatory bowel disease (IBD) affects primarily White patients, about one-quarter of cases are found in non-White racial and ethnic groups. Various factors have combined to lead to disparities in treatment and outcomes for non-Whites with IBD.

Ethnic and racial disparities, along with socioeconomic factors, were the subject of a presentation by Ruby Greywoode, MD, at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“Historical and present-day realities of racial inequity and factors that contribute to socioeconomic status [include] educational and housing policies, employment practices, and generational wealth. Addressing health disparities requires acknowledging these systemic factors,” said Dr. Greywoode, who is with Montefiore Medical Center in New York.

An important concept in discussing health disparity is social determinants of health, which refers to nonbiological factors that affect health and health outcomes. These are “the conditions in which people live, work, learn, and play that affect their health and their quality of life,” said Dr. Greywoode. 

Dr. Greywoode shared examples of social determinants that affect economic stability and financial worry. One study found that one in six IBD patients reported not taking their medications because of cost considerations. A survey of about 900 adults showed that 1 in 4 delayed medical care – half of those because of cost; patients who delayed care were 2.5 times more likely to report an IBD flare in the previous year.

Another important issue is food insecurity. Other presenters at the session emphasized the importance of high-quality nutrition in IBD, and Dr. Greywoode presented one survey showing that only 9% of patients who had both food security and social support reported cost-related medication nonadherence. Among those that had either food insecurity or poor social support, 12% reported cost-related medication nonadherence, but the proportion jumped to 57% among patients who had both food insecurity and lack of social support.

Session comoderator Kelly Issokson noted that socioeconomic factors often interfere with adoption of healthy diets. Whole foods and plant-based foods are expensive, and the financial pressures of the COVID-19 epidemic have made that worse. “Millions of people are slipping into poverty and food insecurity. This is one of the things she highlighted as factors in medication nonadherence,” said Ms. Issokson, who is the clinical nutritional coordinator at the digestive disease clinic at Cedars-Sinai Medical Center in Los Angeles.

Dr. Greywoode also described studies that looked at race, socioeconomic status, and IBD outcomes. A review from 2013 showed disparities among Whites, African Americans, and Hispanics with respect to undergoing ulcerative colitis–related colectomy and Crohn’s disease–related bowel resection. Ulcerative colitis patients on Medicaid had 230% greater in-patient mortality, compared with patients with private insurance, even after adjustment for multiple confounders.

But inequities are not static. “Since this publication, we have numerous other studies drawing conclusions that sometimes agree with and sometimes conflict with it. My belief is that health disparities in IBD will continue to be an active area of research. We know that it takes vigilance to identify, track, and address any disparities when they do arise,” said Dr. Greywoode.

Dr. Greywoode also noted that phenotypic differences based on race and ethnicity influence disparities. She showed results from a meta-analysis that found a difference in the frequency of perianal Crohn’s disease by race and ethnicity; the highest frequency occurred in Black patients (31%), followed by Asians (22%), Whites (14%), and Hispanics (13%). Another study showed that African American patients with Crohn’s disease were more likely to develop a new abscess (adjusted odds ratio, 2.27; 95% confidence interval, 1.31-3.93) or anal fissure (aOR, 1.76; 95% CI, 1.01-3.07), and were also more likely to be initiated on an anti–tumor necrosis factor drug (aOR, 1.85; 95% CI, 1.09-3.14).

Those differences underscore the need to recognize that IBD is not just a disease for White patients. “As we move forward in IBD research, we recognize that individuals of European ancestry are not the only ones who have IBD. There is a growing diverse racial and ethnic population with IBD,” said Dr. Greywoode.

She noted that, in the United States, it is estimated that about one in four adult patients are non-Hispanic African American, Hispanic, Asians, or other ethnicities. Nevertheless, Whites are overrepresented among participants in IBD clinical trials. Some trials are composed of as much as 95% White patients, and sometimes race isn’t even listed. “It’s unclear if [race/ethnicity data are] not collected or not deemed important, but we know that what is not collected is not measured, and what is not measured can’t be evaluated, either to praise or constructively criticize,” said Dr. Greywoode.

Fortunately, there are efforts in place to improve representation in clinical trials. There has been a mandate for almost 3 decades that federally funded research must include racial and ethnic minorities who have been traditionally underrepresented. The Food and Drug Administration has also provided guidance to industry to improve diversity in clinical trial participation, and industry groups have developed strategies, including improved representation among investigators and related early-career development programs. At the community and independent health care practice levels, clinical trial networks encourage patient participation with regulatory and data management support to bolster practices with insufficient resources.

Underrepresentation in clinical trials resonated with comoderator Tina Aswani Omprakash, who is a patient advocate and a master’s in public health student at the Icahn School of Medicine at Mount Sinai, New York. She called for greater awareness among physicians that IBD can occur among people of all backgrounds. “[Providers] would look at me and [say]: ‘There’s no way that, as a South Asian woman, you have that kind of disease.’ There’s that lack of believability,” said Ms. Aswani Omprakash.

Greater recognition of the diversity of patients, as well as the phenotypic differences found among ethnicities, could also inform clinical trial participation and, ultimately, more personalized medicine. “We have to look at these things, observe how they’re affecting populations differently, so that we can have proper medication solutions,” said Ms. Aswani Omprakash.

Dr. Greywoode and Ms. Issokson have no relevant financial disclosures. Ms. Aswani Omprakash has consulted for Genentech, AbbVie, Janssen, and Arena.

The AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. The AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

Updated Feb. 17, 2021.
 

Although inflammatory bowel disease (IBD) affects primarily White patients, about one-quarter of cases are found in non-White racial and ethnic groups. Various factors have combined to lead to disparities in treatment and outcomes for non-Whites with IBD.

Ethnic and racial disparities, along with socioeconomic factors, were the subject of a presentation by Ruby Greywoode, MD, at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“Historical and present-day realities of racial inequity and factors that contribute to socioeconomic status [include] educational and housing policies, employment practices, and generational wealth. Addressing health disparities requires acknowledging these systemic factors,” said Dr. Greywoode, who is with Montefiore Medical Center in New York.

An important concept in discussing health disparity is social determinants of health, which refers to nonbiological factors that affect health and health outcomes. These are “the conditions in which people live, work, learn, and play that affect their health and their quality of life,” said Dr. Greywoode. 

Dr. Greywoode shared examples of social determinants that affect economic stability and financial worry. One study found that one in six IBD patients reported not taking their medications because of cost considerations. A survey of about 900 adults showed that 1 in 4 delayed medical care – half of those because of cost; patients who delayed care were 2.5 times more likely to report an IBD flare in the previous year.

Another important issue is food insecurity. Other presenters at the session emphasized the importance of high-quality nutrition in IBD, and Dr. Greywoode presented one survey showing that only 9% of patients who had both food security and social support reported cost-related medication nonadherence. Among those that had either food insecurity or poor social support, 12% reported cost-related medication nonadherence, but the proportion jumped to 57% among patients who had both food insecurity and lack of social support.

Session comoderator Kelly Issokson noted that socioeconomic factors often interfere with adoption of healthy diets. Whole foods and plant-based foods are expensive, and the financial pressures of the COVID-19 epidemic have made that worse. “Millions of people are slipping into poverty and food insecurity. This is one of the things she highlighted as factors in medication nonadherence,” said Ms. Issokson, who is the clinical nutritional coordinator at the digestive disease clinic at Cedars-Sinai Medical Center in Los Angeles.

Dr. Greywoode also described studies that looked at race, socioeconomic status, and IBD outcomes. A review from 2013 showed disparities among Whites, African Americans, and Hispanics with respect to undergoing ulcerative colitis–related colectomy and Crohn’s disease–related bowel resection. Ulcerative colitis patients on Medicaid had 230% greater in-patient mortality, compared with patients with private insurance, even after adjustment for multiple confounders.

But inequities are not static. “Since this publication, we have numerous other studies drawing conclusions that sometimes agree with and sometimes conflict with it. My belief is that health disparities in IBD will continue to be an active area of research. We know that it takes vigilance to identify, track, and address any disparities when they do arise,” said Dr. Greywoode.

Dr. Greywoode also noted that phenotypic differences based on race and ethnicity influence disparities. She showed results from a meta-analysis that found a difference in the frequency of perianal Crohn’s disease by race and ethnicity; the highest frequency occurred in Black patients (31%), followed by Asians (22%), Whites (14%), and Hispanics (13%). Another study showed that African American patients with Crohn’s disease were more likely to develop a new abscess (adjusted odds ratio, 2.27; 95% confidence interval, 1.31-3.93) or anal fissure (aOR, 1.76; 95% CI, 1.01-3.07), and were also more likely to be initiated on an anti–tumor necrosis factor drug (aOR, 1.85; 95% CI, 1.09-3.14).

Those differences underscore the need to recognize that IBD is not just a disease for White patients. “As we move forward in IBD research, we recognize that individuals of European ancestry are not the only ones who have IBD. There is a growing diverse racial and ethnic population with IBD,” said Dr. Greywoode.

She noted that, in the United States, it is estimated that about one in four adult patients are non-Hispanic African American, Hispanic, Asians, or other ethnicities. Nevertheless, Whites are overrepresented among participants in IBD clinical trials. Some trials are composed of as much as 95% White patients, and sometimes race isn’t even listed. “It’s unclear if [race/ethnicity data are] not collected or not deemed important, but we know that what is not collected is not measured, and what is not measured can’t be evaluated, either to praise or constructively criticize,” said Dr. Greywoode.

Fortunately, there are efforts in place to improve representation in clinical trials. There has been a mandate for almost 3 decades that federally funded research must include racial and ethnic minorities who have been traditionally underrepresented. The Food and Drug Administration has also provided guidance to industry to improve diversity in clinical trial participation, and industry groups have developed strategies, including improved representation among investigators and related early-career development programs. At the community and independent health care practice levels, clinical trial networks encourage patient participation with regulatory and data management support to bolster practices with insufficient resources.

Underrepresentation in clinical trials resonated with comoderator Tina Aswani Omprakash, who is a patient advocate and a master’s in public health student at the Icahn School of Medicine at Mount Sinai, New York. She called for greater awareness among physicians that IBD can occur among people of all backgrounds. “[Providers] would look at me and [say]: ‘There’s no way that, as a South Asian woman, you have that kind of disease.’ There’s that lack of believability,” said Ms. Aswani Omprakash.

Greater recognition of the diversity of patients, as well as the phenotypic differences found among ethnicities, could also inform clinical trial participation and, ultimately, more personalized medicine. “We have to look at these things, observe how they’re affecting populations differently, so that we can have proper medication solutions,” said Ms. Aswani Omprakash.

Dr. Greywoode and Ms. Issokson have no relevant financial disclosures. Ms. Aswani Omprakash has consulted for Genentech, AbbVie, Janssen, and Arena.

The AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. The AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

Updated Feb. 17, 2021.
 

Although inflammatory bowel disease (IBD) affects primarily White patients, about one-quarter of cases are found in non-White racial and ethnic groups. Various factors have combined to lead to disparities in treatment and outcomes for non-Whites with IBD.

Ethnic and racial disparities, along with socioeconomic factors, were the subject of a presentation by Ruby Greywoode, MD, at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

“Historical and present-day realities of racial inequity and factors that contribute to socioeconomic status [include] educational and housing policies, employment practices, and generational wealth. Addressing health disparities requires acknowledging these systemic factors,” said Dr. Greywoode, who is with Montefiore Medical Center in New York.

An important concept in discussing health disparity is social determinants of health, which refers to nonbiological factors that affect health and health outcomes. These are “the conditions in which people live, work, learn, and play that affect their health and their quality of life,” said Dr. Greywoode. 

Dr. Greywoode shared examples of social determinants that affect economic stability and financial worry. One study found that one in six IBD patients reported not taking their medications because of cost considerations. A survey of about 900 adults showed that 1 in 4 delayed medical care – half of those because of cost; patients who delayed care were 2.5 times more likely to report an IBD flare in the previous year.

Another important issue is food insecurity. Other presenters at the session emphasized the importance of high-quality nutrition in IBD, and Dr. Greywoode presented one survey showing that only 9% of patients who had both food security and social support reported cost-related medication nonadherence. Among those that had either food insecurity or poor social support, 12% reported cost-related medication nonadherence, but the proportion jumped to 57% among patients who had both food insecurity and lack of social support.

Session comoderator Kelly Issokson noted that socioeconomic factors often interfere with adoption of healthy diets. Whole foods and plant-based foods are expensive, and the financial pressures of the COVID-19 epidemic have made that worse. “Millions of people are slipping into poverty and food insecurity. This is one of the things she highlighted as factors in medication nonadherence,” said Ms. Issokson, who is the clinical nutritional coordinator at the digestive disease clinic at Cedars-Sinai Medical Center in Los Angeles.

Dr. Greywoode also described studies that looked at race, socioeconomic status, and IBD outcomes. A review from 2013 showed disparities among Whites, African Americans, and Hispanics with respect to undergoing ulcerative colitis–related colectomy and Crohn’s disease–related bowel resection. Ulcerative colitis patients on Medicaid had 230% greater in-patient mortality, compared with patients with private insurance, even after adjustment for multiple confounders.

But inequities are not static. “Since this publication, we have numerous other studies drawing conclusions that sometimes agree with and sometimes conflict with it. My belief is that health disparities in IBD will continue to be an active area of research. We know that it takes vigilance to identify, track, and address any disparities when they do arise,” said Dr. Greywoode.

Dr. Greywoode also noted that phenotypic differences based on race and ethnicity influence disparities. She showed results from a meta-analysis that found a difference in the frequency of perianal Crohn’s disease by race and ethnicity; the highest frequency occurred in Black patients (31%), followed by Asians (22%), Whites (14%), and Hispanics (13%). Another study showed that African American patients with Crohn’s disease were more likely to develop a new abscess (adjusted odds ratio, 2.27; 95% confidence interval, 1.31-3.93) or anal fissure (aOR, 1.76; 95% CI, 1.01-3.07), and were also more likely to be initiated on an anti–tumor necrosis factor drug (aOR, 1.85; 95% CI, 1.09-3.14).

Those differences underscore the need to recognize that IBD is not just a disease for White patients. “As we move forward in IBD research, we recognize that individuals of European ancestry are not the only ones who have IBD. There is a growing diverse racial and ethnic population with IBD,” said Dr. Greywoode.

She noted that, in the United States, it is estimated that about one in four adult patients are non-Hispanic African American, Hispanic, Asians, or other ethnicities. Nevertheless, Whites are overrepresented among participants in IBD clinical trials. Some trials are composed of as much as 95% White patients, and sometimes race isn’t even listed. “It’s unclear if [race/ethnicity data are] not collected or not deemed important, but we know that what is not collected is not measured, and what is not measured can’t be evaluated, either to praise or constructively criticize,” said Dr. Greywoode.

Fortunately, there are efforts in place to improve representation in clinical trials. There has been a mandate for almost 3 decades that federally funded research must include racial and ethnic minorities who have been traditionally underrepresented. The Food and Drug Administration has also provided guidance to industry to improve diversity in clinical trial participation, and industry groups have developed strategies, including improved representation among investigators and related early-career development programs. At the community and independent health care practice levels, clinical trial networks encourage patient participation with regulatory and data management support to bolster practices with insufficient resources.

Underrepresentation in clinical trials resonated with comoderator Tina Aswani Omprakash, who is a patient advocate and a master’s in public health student at the Icahn School of Medicine at Mount Sinai, New York. She called for greater awareness among physicians that IBD can occur among people of all backgrounds. “[Providers] would look at me and [say]: ‘There’s no way that, as a South Asian woman, you have that kind of disease.’ There’s that lack of believability,” said Ms. Aswani Omprakash.

Greater recognition of the diversity of patients, as well as the phenotypic differences found among ethnicities, could also inform clinical trial participation and, ultimately, more personalized medicine. “We have to look at these things, observe how they’re affecting populations differently, so that we can have proper medication solutions,” said Ms. Aswani Omprakash.

Dr. Greywoode and Ms. Issokson have no relevant financial disclosures. Ms. Aswani Omprakash has consulted for Genentech, AbbVie, Janssen, and Arena.

The AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. The AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

Updated Feb. 17, 2021.