The combination of fecal microbiota transplantation (FMT) and an anti-inflammatory diet (AID) successfully induced and sustained remission of ulcerative colitis (UC) more effectively than optimizing medications for the condition did, according to a randomized controlled trial published in the journal Gut.

”Deep remission at 48 weeks was also significantly better in the FMT-AID arm, suggesting that the anti-inflammatory diet could sustain the FMT-AID–induced endoscopic and clinical remission,” wrote Saurabh Kedia, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues. “The adherence to modified diet was maintained until 48 weeks, suggesting the acceptability of this approach to patients.”

The open-label trial involved 66 patients with mild to moderate UC, based on a Simple Clinical Colitis Activity Index (SCCAI) score in the range of 3-9 and a score above 1 on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Their average age was 35, and 34.8% of the participants had pancolitis. Their median SCCAI score was 6 (interquartile range, 5-7), and their median UCEIS score was 4 (IQR, 3-5) at enrollment.

The control group of 31 patients received standard medical therapy, which meant continuing on their baseline medications along with optimization of their therapy. The optimization involved increasing 5-aminosalicylic acid and/or adding topical therapy (topical 5-ASA or topical steroids in those already on topical 5-ASA); steroid dose was increased in patients already on topical steroids and 5-ASA.

The 35 patients randomized to the FMT-AID arm received seven weekly colonoscopic infusions of FMT from multiple donors, drawn from healthy rural adults aged 18-45, and were instructed to follow an anti-inflammatory diet. The anti-inflammatory diet was “rich in dietary constituents that expand T-regulatory cells, promote healthy microbiota, and improve the intestinal barrier, and poor in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier,” the authors wrote. Foods to avoid included gluten-based grains, dairy products, processed and red meat, food additives, and refined sugars. Participants were encouraged to increase their intake of fresh fruit and vegetables, fermented foods, cruciferous vegetables, and polyphenols. The patients received a diet chart to follow, and a dietitian called every 2 weeks during the first 2 months to assess diet compliance.

The patients’ outcomes were assessed at 8 weeks with blood and stool samples and endoscopy, scored by an assignment-blinded physician. The primary outcome consisted of both clinical remission (SCCAI score of 2 or less) and endoscopic remission (UCEIS score of 1 or less), which the investigators considered deep remission. They also looked at those who clinically responded – a decline in SCCAI of at least 3 points – even if they didn’t reach remission. The researchers defined treatment failure as either an increase in SCCAI of at least 3 points with a rectal bleeding score of at least 1, or a need for oral steroids without improvement of at least 3 points in their SCCAI score.

At 8 weeks, patients in the FMT-AID arm were more than three times more likely to achieve remission or clinically respond than those receiving standard medical therapy. Two-thirds of those in the FMT-AID arm (65.7%) clinically responded, compared with 35.5% of those receiving standard therapy (odds ratio, 3.5; 95% confidence interval, 1.3-9.6). Clinical remission occurred in 60% of those in the FMT-AID arm, compared with 32.3% of the standard therapy arm (OR, 3.2; 95% CI, 1.1-8.7). Just over half the FMT-AID arm participants (51.5%) showed endoscopic response, compared with 17.4% of those with standard therapy (OR, 5.0; 95% CI, 1.4-18.1). Endoscopic remission was also greater in the FMT-AID group (36.4%) than the standard therapy group (17.4%) but without statistical significance (P = .15). Finally, about a third of the FMT-AID arm experienced deep remission (36.4%), compared with 8.7% of the standard therapy arm (OR, 6.0; 95% CI, 1.2-30.2). Those in the FMT-AID arm with milder disease or left-sided colitis were significantly more likely to reach clinical remission, and all the patients who hadn’t taken steroids had remission.

Those with clinical response or remission at 8 weeks – 23 people in the FMT-AID arm and 11 in the standard therapy arm – were then followed for the next 40 weeks. During that period, participants in the FMT-AID arm continued their anti-inflammatory diet and medications while the standard medical care group took only their medications.

At 48 weeks, half the original cohort of FMT-AID patients had maintained clinical remission or response, compared with a third of the standard care group, but the difference between the groups didn’t reach significance. However, a quarter of FMT-AID participants (25%) had maintained endoscopic remission, compared with none in the standard therapy arm (P = .007), and the same was true for deep remission (25% vs. 0%; P = .007).

Adverse events were similar in the FMT-AID (74%) and standard care (87%) arms and mild or moderate, mainly abdominal pain, bloating, gas, diarrhea, and worsened disease activity.

A substantial challenge in the trial came from interruptions because of the COVID-19 pandemic. Among the 66 trial participants, 52 were recruited between September 2019 and March 2020, when the pandemic prevented further recruitment. The remaining 14 participants were recruited between August and November 2021.

“The major strength of our study was a unique protocol combining two microbiome manipulation strategies: FMT and diet,” the authors wrote. “While both were used for induction of remission, the effect was maintained only with diet, which adds novelty to the study design.”

Vineet Ahuja, MD, DM, the paper’s senior author and a professor of gastroenterology at the All India Institute of Medical Sciences, said there likely wasn’t any major impact from the pandemic on participants’ ability to follow the diet given that none mentioned it during the dietitian calls.

”There are less possible chances of recall bias since we had a dedicated IBD dietician who would contact patients regularly for recalling the diet,” Dr. Ahuja said in an interview. “We also have created a diet app, IBD Nutricare, in which real-time recording of daily diet can be done by the patient and the input is analyzable at the web end.”

Most in the FMT-AID arm (84.6%) were qualitatively highly adherent to the diet at 8 weeks, with the other 15.4% moderately adherent. The highly adherent rate fell to 66.7% at 48 weeks, with the other third remaining moderately adherent. No patients were poorly or nonadherent during the study. At 8 weeks, 92.3% of patients were avoiding prohibited foods, which fell to 71.4% at 48 weeks.

Ashwin Ananthakrishnan, MBBS, MPH, an associate professor of medicine at Massachusetts General Hospital and director of the MGH Crohn’s and Colitis center in Boston, found the study design “intriguing and practical.”

”Prior studies of FMT in UC examined UC alone – they required fairly high intensity of FMT treatment for the entire duration of the trial – consequently they may not be sustainable in real world practice,” Dr. Ananthakrishnan said in an interview. “This is a more practically applicable study where the dietary intervention could be continued for a longer period of time. So in all, it’s a very promising study and provides a lot of guidance into how to practically position these treatments.”

The authors similarly noted that the two-intervention approach is ”practical for patients as they can practice the modified diet at home and avoid hospital visits for repeat FMTs.” The authors also noted that their study “provides a low-cost, safe alternative for IBD physicians in resource-limited settings.”

That said, Dr. Ananthakrishnan drew attention to the small size of the study as a limitation.

”To what degree the sustained benefit was due to AID vs. FMT cannot be established,” Dr. Ananthakrishnan said. “The optimized standard medical therapy arm had patients with mild disease who had only minor adjustments to their baseline treatment. Whether they would have had similar benefit if they had been treated with a short course of systemic steroids and continued their optimized treatment is unclear.”

The research was funded by a grant from the Indian Council of Medical Research. The authors and Dr. Ananthakrishnan reported no conflicts of interest.

The combination of fecal microbiota transplantation (FMT) and an anti-inflammatory diet (AID) successfully induced and sustained remission of ulcerative colitis (UC) more effectively than optimizing medications for the condition did, according to a randomized controlled trial published in the journal Gut.

”Deep remission at 48 weeks was also significantly better in the FMT-AID arm, suggesting that the anti-inflammatory diet could sustain the FMT-AID–induced endoscopic and clinical remission,” wrote Saurabh Kedia, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues. “The adherence to modified diet was maintained until 48 weeks, suggesting the acceptability of this approach to patients.”

The open-label trial involved 66 patients with mild to moderate UC, based on a Simple Clinical Colitis Activity Index (SCCAI) score in the range of 3-9 and a score above 1 on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Their average age was 35, and 34.8% of the participants had pancolitis. Their median SCCAI score was 6 (interquartile range, 5-7), and their median UCEIS score was 4 (IQR, 3-5) at enrollment.

The control group of 31 patients received standard medical therapy, which meant continuing on their baseline medications along with optimization of their therapy. The optimization involved increasing 5-aminosalicylic acid and/or adding topical therapy (topical 5-ASA or topical steroids in those already on topical 5-ASA); steroid dose was increased in patients already on topical steroids and 5-ASA.

The 35 patients randomized to the FMT-AID arm received seven weekly colonoscopic infusions of FMT from multiple donors, drawn from healthy rural adults aged 18-45, and were instructed to follow an anti-inflammatory diet. The anti-inflammatory diet was “rich in dietary constituents that expand T-regulatory cells, promote healthy microbiota, and improve the intestinal barrier, and poor in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier,” the authors wrote. Foods to avoid included gluten-based grains, dairy products, processed and red meat, food additives, and refined sugars. Participants were encouraged to increase their intake of fresh fruit and vegetables, fermented foods, cruciferous vegetables, and polyphenols. The patients received a diet chart to follow, and a dietitian called every 2 weeks during the first 2 months to assess diet compliance.

The patients’ outcomes were assessed at 8 weeks with blood and stool samples and endoscopy, scored by an assignment-blinded physician. The primary outcome consisted of both clinical remission (SCCAI score of 2 or less) and endoscopic remission (UCEIS score of 1 or less), which the investigators considered deep remission. They also looked at those who clinically responded – a decline in SCCAI of at least 3 points – even if they didn’t reach remission. The researchers defined treatment failure as either an increase in SCCAI of at least 3 points with a rectal bleeding score of at least 1, or a need for oral steroids without improvement of at least 3 points in their SCCAI score.

At 8 weeks, patients in the FMT-AID arm were more than three times more likely to achieve remission or clinically respond than those receiving standard medical therapy. Two-thirds of those in the FMT-AID arm (65.7%) clinically responded, compared with 35.5% of those receiving standard therapy (odds ratio, 3.5; 95% confidence interval, 1.3-9.6). Clinical remission occurred in 60% of those in the FMT-AID arm, compared with 32.3% of the standard therapy arm (OR, 3.2; 95% CI, 1.1-8.7). Just over half the FMT-AID arm participants (51.5%) showed endoscopic response, compared with 17.4% of those with standard therapy (OR, 5.0; 95% CI, 1.4-18.1). Endoscopic remission was also greater in the FMT-AID group (36.4%) than the standard therapy group (17.4%) but without statistical significance (P = .15). Finally, about a third of the FMT-AID arm experienced deep remission (36.4%), compared with 8.7% of the standard therapy arm (OR, 6.0; 95% CI, 1.2-30.2). Those in the FMT-AID arm with milder disease or left-sided colitis were significantly more likely to reach clinical remission, and all the patients who hadn’t taken steroids had remission.

Those with clinical response or remission at 8 weeks – 23 people in the FMT-AID arm and 11 in the standard therapy arm – were then followed for the next 40 weeks. During that period, participants in the FMT-AID arm continued their anti-inflammatory diet and medications while the standard medical care group took only their medications.

At 48 weeks, half the original cohort of FMT-AID patients had maintained clinical remission or response, compared with a third of the standard care group, but the difference between the groups didn’t reach significance. However, a quarter of FMT-AID participants (25%) had maintained endoscopic remission, compared with none in the standard therapy arm (P = .007), and the same was true for deep remission (25% vs. 0%; P = .007).

Adverse events were similar in the FMT-AID (74%) and standard care (87%) arms and mild or moderate, mainly abdominal pain, bloating, gas, diarrhea, and worsened disease activity.

A substantial challenge in the trial came from interruptions because of the COVID-19 pandemic. Among the 66 trial participants, 52 were recruited between September 2019 and March 2020, when the pandemic prevented further recruitment. The remaining 14 participants were recruited between August and November 2021.

“The major strength of our study was a unique protocol combining two microbiome manipulation strategies: FMT and diet,” the authors wrote. “While both were used for induction of remission, the effect was maintained only with diet, which adds novelty to the study design.”

Vineet Ahuja, MD, DM, the paper’s senior author and a professor of gastroenterology at the All India Institute of Medical Sciences, said there likely wasn’t any major impact from the pandemic on participants’ ability to follow the diet given that none mentioned it during the dietitian calls.

”There are less possible chances of recall bias since we had a dedicated IBD dietician who would contact patients regularly for recalling the diet,” Dr. Ahuja said in an interview. “We also have created a diet app, IBD Nutricare, in which real-time recording of daily diet can be done by the patient and the input is analyzable at the web end.”

Most in the FMT-AID arm (84.6%) were qualitatively highly adherent to the diet at 8 weeks, with the other 15.4% moderately adherent. The highly adherent rate fell to 66.7% at 48 weeks, with the other third remaining moderately adherent. No patients were poorly or nonadherent during the study. At 8 weeks, 92.3% of patients were avoiding prohibited foods, which fell to 71.4% at 48 weeks.

Ashwin Ananthakrishnan, MBBS, MPH, an associate professor of medicine at Massachusetts General Hospital and director of the MGH Crohn’s and Colitis center in Boston, found the study design “intriguing and practical.”

”Prior studies of FMT in UC examined UC alone – they required fairly high intensity of FMT treatment for the entire duration of the trial – consequently they may not be sustainable in real world practice,” Dr. Ananthakrishnan said in an interview. “This is a more practically applicable study where the dietary intervention could be continued for a longer period of time. So in all, it’s a very promising study and provides a lot of guidance into how to practically position these treatments.”

The authors similarly noted that the two-intervention approach is ”practical for patients as they can practice the modified diet at home and avoid hospital visits for repeat FMTs.” The authors also noted that their study “provides a low-cost, safe alternative for IBD physicians in resource-limited settings.”

That said, Dr. Ananthakrishnan drew attention to the small size of the study as a limitation.

”To what degree the sustained benefit was due to AID vs. FMT cannot be established,” Dr. Ananthakrishnan said. “The optimized standard medical therapy arm had patients with mild disease who had only minor adjustments to their baseline treatment. Whether they would have had similar benefit if they had been treated with a short course of systemic steroids and continued their optimized treatment is unclear.”

The research was funded by a grant from the Indian Council of Medical Research. The authors and Dr. Ananthakrishnan reported no conflicts of interest.

The combination of fecal microbiota transplantation (FMT) and an anti-inflammatory diet (AID) successfully induced and sustained remission of ulcerative colitis (UC) more effectively than optimizing medications for the condition did, according to a randomized controlled trial published in the journal Gut.

”Deep remission at 48 weeks was also significantly better in the FMT-AID arm, suggesting that the anti-inflammatory diet could sustain the FMT-AID–induced endoscopic and clinical remission,” wrote Saurabh Kedia, MD, of the All India Institute of Medical Sciences in New Delhi, and colleagues. “The adherence to modified diet was maintained until 48 weeks, suggesting the acceptability of this approach to patients.”

The open-label trial involved 66 patients with mild to moderate UC, based on a Simple Clinical Colitis Activity Index (SCCAI) score in the range of 3-9 and a score above 1 on the Ulcerative Colitis Endoscopic Index of Severity (UCEIS). Their average age was 35, and 34.8% of the participants had pancolitis. Their median SCCAI score was 6 (interquartile range, 5-7), and their median UCEIS score was 4 (IQR, 3-5) at enrollment.

The control group of 31 patients received standard medical therapy, which meant continuing on their baseline medications along with optimization of their therapy. The optimization involved increasing 5-aminosalicylic acid and/or adding topical therapy (topical 5-ASA or topical steroids in those already on topical 5-ASA); steroid dose was increased in patients already on topical steroids and 5-ASA.

The 35 patients randomized to the FMT-AID arm received seven weekly colonoscopic infusions of FMT from multiple donors, drawn from healthy rural adults aged 18-45, and were instructed to follow an anti-inflammatory diet. The anti-inflammatory diet was “rich in dietary constituents that expand T-regulatory cells, promote healthy microbiota, and improve the intestinal barrier, and poor in dietary constituents that cause dysbiosis or have negative effect on intestinal barrier,” the authors wrote. Foods to avoid included gluten-based grains, dairy products, processed and red meat, food additives, and refined sugars. Participants were encouraged to increase their intake of fresh fruit and vegetables, fermented foods, cruciferous vegetables, and polyphenols. The patients received a diet chart to follow, and a dietitian called every 2 weeks during the first 2 months to assess diet compliance.

The patients’ outcomes were assessed at 8 weeks with blood and stool samples and endoscopy, scored by an assignment-blinded physician. The primary outcome consisted of both clinical remission (SCCAI score of 2 or less) and endoscopic remission (UCEIS score of 1 or less), which the investigators considered deep remission. They also looked at those who clinically responded – a decline in SCCAI of at least 3 points – even if they didn’t reach remission. The researchers defined treatment failure as either an increase in SCCAI of at least 3 points with a rectal bleeding score of at least 1, or a need for oral steroids without improvement of at least 3 points in their SCCAI score.

At 8 weeks, patients in the FMT-AID arm were more than three times more likely to achieve remission or clinically respond than those receiving standard medical therapy. Two-thirds of those in the FMT-AID arm (65.7%) clinically responded, compared with 35.5% of those receiving standard therapy (odds ratio, 3.5; 95% confidence interval, 1.3-9.6). Clinical remission occurred in 60% of those in the FMT-AID arm, compared with 32.3% of the standard therapy arm (OR, 3.2; 95% CI, 1.1-8.7). Just over half the FMT-AID arm participants (51.5%) showed endoscopic response, compared with 17.4% of those with standard therapy (OR, 5.0; 95% CI, 1.4-18.1). Endoscopic remission was also greater in the FMT-AID group (36.4%) than the standard therapy group (17.4%) but without statistical significance (P = .15). Finally, about a third of the FMT-AID arm experienced deep remission (36.4%), compared with 8.7% of the standard therapy arm (OR, 6.0; 95% CI, 1.2-30.2). Those in the FMT-AID arm with milder disease or left-sided colitis were significantly more likely to reach clinical remission, and all the patients who hadn’t taken steroids had remission.

Those with clinical response or remission at 8 weeks – 23 people in the FMT-AID arm and 11 in the standard therapy arm – were then followed for the next 40 weeks. During that period, participants in the FMT-AID arm continued their anti-inflammatory diet and medications while the standard medical care group took only their medications.

At 48 weeks, half the original cohort of FMT-AID patients had maintained clinical remission or response, compared with a third of the standard care group, but the difference between the groups didn’t reach significance. However, a quarter of FMT-AID participants (25%) had maintained endoscopic remission, compared with none in the standard therapy arm (P = .007), and the same was true for deep remission (25% vs. 0%; P = .007).

Adverse events were similar in the FMT-AID (74%) and standard care (87%) arms and mild or moderate, mainly abdominal pain, bloating, gas, diarrhea, and worsened disease activity.

A substantial challenge in the trial came from interruptions because of the COVID-19 pandemic. Among the 66 trial participants, 52 were recruited between September 2019 and March 2020, when the pandemic prevented further recruitment. The remaining 14 participants were recruited between August and November 2021.

“The major strength of our study was a unique protocol combining two microbiome manipulation strategies: FMT and diet,” the authors wrote. “While both were used for induction of remission, the effect was maintained only with diet, which adds novelty to the study design.”

Vineet Ahuja, MD, DM, the paper’s senior author and a professor of gastroenterology at the All India Institute of Medical Sciences, said there likely wasn’t any major impact from the pandemic on participants’ ability to follow the diet given that none mentioned it during the dietitian calls.

”There are less possible chances of recall bias since we had a dedicated IBD dietician who would contact patients regularly for recalling the diet,” Dr. Ahuja said in an interview. “We also have created a diet app, IBD Nutricare, in which real-time recording of daily diet can be done by the patient and the input is analyzable at the web end.”

Most in the FMT-AID arm (84.6%) were qualitatively highly adherent to the diet at 8 weeks, with the other 15.4% moderately adherent. The highly adherent rate fell to 66.7% at 48 weeks, with the other third remaining moderately adherent. No patients were poorly or nonadherent during the study. At 8 weeks, 92.3% of patients were avoiding prohibited foods, which fell to 71.4% at 48 weeks.

Ashwin Ananthakrishnan, MBBS, MPH, an associate professor of medicine at Massachusetts General Hospital and director of the MGH Crohn’s and Colitis center in Boston, found the study design “intriguing and practical.”

”Prior studies of FMT in UC examined UC alone – they required fairly high intensity of FMT treatment for the entire duration of the trial – consequently they may not be sustainable in real world practice,” Dr. Ananthakrishnan said in an interview. “This is a more practically applicable study where the dietary intervention could be continued for a longer period of time. So in all, it’s a very promising study and provides a lot of guidance into how to practically position these treatments.”

The authors similarly noted that the two-intervention approach is ”practical for patients as they can practice the modified diet at home and avoid hospital visits for repeat FMTs.” The authors also noted that their study “provides a low-cost, safe alternative for IBD physicians in resource-limited settings.”

That said, Dr. Ananthakrishnan drew attention to the small size of the study as a limitation.

”To what degree the sustained benefit was due to AID vs. FMT cannot be established,” Dr. Ananthakrishnan said. “The optimized standard medical therapy arm had patients with mild disease who had only minor adjustments to their baseline treatment. Whether they would have had similar benefit if they had been treated with a short course of systemic steroids and continued their optimized treatment is unclear.”

The research was funded by a grant from the Indian Council of Medical Research. The authors and Dr. Ananthakrishnan reported no conflicts of interest.

A provider-only patient care protocol was safe and efficient for delivery of emergency department care in response to pandemic-related staff shortages, based on data from nearly 3,000 patients.

The COVID-19 pandemic sparked a shortage of health care personnel, according to Tanveer Gaibi, MD, of INOVA Fairfax Hospital, Falls Church, Va., and colleagues. To help manage these challenges, the INOVA emergency department developed a Provider-Only Patients (POP) protocol for patients who required minimal nursing care.

In a study presented at the American College of Emergency Physicians 2022 Scientific Assembly, the researchers reported the outcomes of a cohort of patients with suspected COVID-19 who were treated in the emergency department using the POP protocol between Dec. 1, 2021, and Jan. 15, 2022. The patients ranged in age from 21 to 64, and all presented with COVID-19-related complaints, with an Emergency Severity Index (ESI) of 4 or 5, with 1 being the most urgent and 5 being the least urgent.

Patients were triaged by a physician or nurse to determine POP status. Those deemed POP were seen and discharged directly by a physician or advanced-practice provider (APP). The researchers reviewed data from a total of 640 patients treated via the POP protocol and 2,386 patients who were not POP with ESI of 4 or 5.

Overall, the mean time from when a patient was initially seen by a provider to the discharge disposition was 48 minutes shorter for POP, and the mean time from discharge disposition placement to leaving the ED was 66 minutes shorter. None of the POP-protocol patients were readmitted within 72 hours of discharge. The researchers estimated that the 640 patients in the POP protocol saved approximately 1892.27 hours of nursing and 705.1 provider hours during the study period, and no additional physician hours or advanced-practice provider hours were needed.

The study findings suggest that POP holds up as a safe, efficient, and effective process that can reduce discharge length of stay and provider to disposition times. Although more research is needed, the POP model also may be considered to address staffing challenges unrelated to the pandemic, the researchers concluded.

“This study was conducted at [a] time when our emergency department was experiencing a sudden and disproportionate increase in volume related to the Omicron variant of COVID-19,” Dr. Gaibi told this news organization. “This novel process was developed by brainstorming untested ways of managing this increased demand. The research study was a natural outcome once the process was implemented,” he said.

“Once barriers to implementing this process were overcome, we were not surprised by the results,” Dr. Gaibi said. “Subtracting at the time for nursing process was anticipated to shorten cycle times.”

The clinical implications of POP relate to generalizability outside of the pandemic setting, Dr. Gaibi noted. “We anticipate that POP could be used for patients with minor complaints to greatly shorten their time in the emergency department,” he said.

“Potential barriers to the generalized use of POP relate, in part, to local administrative barriers related to nursing assessments,” Dr. Gaibi explained. “Further, POP patients should be simple and require little or no testing. Keeping to this strict definition of the provider-only patient may be a pitfall in terms of its hard wiring,” he added.

Looking ahead, more research is needed to study POP in ED patients with minor complaints not necessarily related to COVID-19, Dr. Gaibi said.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

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

A provider-only patient care protocol was safe and efficient for delivery of emergency department care in response to pandemic-related staff shortages, based on data from nearly 3,000 patients.

The COVID-19 pandemic sparked a shortage of health care personnel, according to Tanveer Gaibi, MD, of INOVA Fairfax Hospital, Falls Church, Va., and colleagues. To help manage these challenges, the INOVA emergency department developed a Provider-Only Patients (POP) protocol for patients who required minimal nursing care.

In a study presented at the American College of Emergency Physicians 2022 Scientific Assembly, the researchers reported the outcomes of a cohort of patients with suspected COVID-19 who were treated in the emergency department using the POP protocol between Dec. 1, 2021, and Jan. 15, 2022. The patients ranged in age from 21 to 64, and all presented with COVID-19-related complaints, with an Emergency Severity Index (ESI) of 4 or 5, with 1 being the most urgent and 5 being the least urgent.

Patients were triaged by a physician or nurse to determine POP status. Those deemed POP were seen and discharged directly by a physician or advanced-practice provider (APP). The researchers reviewed data from a total of 640 patients treated via the POP protocol and 2,386 patients who were not POP with ESI of 4 or 5.

Overall, the mean time from when a patient was initially seen by a provider to the discharge disposition was 48 minutes shorter for POP, and the mean time from discharge disposition placement to leaving the ED was 66 minutes shorter. None of the POP-protocol patients were readmitted within 72 hours of discharge. The researchers estimated that the 640 patients in the POP protocol saved approximately 1892.27 hours of nursing and 705.1 provider hours during the study period, and no additional physician hours or advanced-practice provider hours were needed.

The study findings suggest that POP holds up as a safe, efficient, and effective process that can reduce discharge length of stay and provider to disposition times. Although more research is needed, the POP model also may be considered to address staffing challenges unrelated to the pandemic, the researchers concluded.

“This study was conducted at [a] time when our emergency department was experiencing a sudden and disproportionate increase in volume related to the Omicron variant of COVID-19,” Dr. Gaibi told this news organization. “This novel process was developed by brainstorming untested ways of managing this increased demand. The research study was a natural outcome once the process was implemented,” he said.

“Once barriers to implementing this process were overcome, we were not surprised by the results,” Dr. Gaibi said. “Subtracting at the time for nursing process was anticipated to shorten cycle times.”

The clinical implications of POP relate to generalizability outside of the pandemic setting, Dr. Gaibi noted. “We anticipate that POP could be used for patients with minor complaints to greatly shorten their time in the emergency department,” he said.

“Potential barriers to the generalized use of POP relate, in part, to local administrative barriers related to nursing assessments,” Dr. Gaibi explained. “Further, POP patients should be simple and require little or no testing. Keeping to this strict definition of the provider-only patient may be a pitfall in terms of its hard wiring,” he added.

Looking ahead, more research is needed to study POP in ED patients with minor complaints not necessarily related to COVID-19, Dr. Gaibi said.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

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

A provider-only patient care protocol was safe and efficient for delivery of emergency department care in response to pandemic-related staff shortages, based on data from nearly 3,000 patients.

The COVID-19 pandemic sparked a shortage of health care personnel, according to Tanveer Gaibi, MD, of INOVA Fairfax Hospital, Falls Church, Va., and colleagues. To help manage these challenges, the INOVA emergency department developed a Provider-Only Patients (POP) protocol for patients who required minimal nursing care.

In a study presented at the American College of Emergency Physicians 2022 Scientific Assembly, the researchers reported the outcomes of a cohort of patients with suspected COVID-19 who were treated in the emergency department using the POP protocol between Dec. 1, 2021, and Jan. 15, 2022. The patients ranged in age from 21 to 64, and all presented with COVID-19-related complaints, with an Emergency Severity Index (ESI) of 4 or 5, with 1 being the most urgent and 5 being the least urgent.

Patients were triaged by a physician or nurse to determine POP status. Those deemed POP were seen and discharged directly by a physician or advanced-practice provider (APP). The researchers reviewed data from a total of 640 patients treated via the POP protocol and 2,386 patients who were not POP with ESI of 4 or 5.

Overall, the mean time from when a patient was initially seen by a provider to the discharge disposition was 48 minutes shorter for POP, and the mean time from discharge disposition placement to leaving the ED was 66 minutes shorter. None of the POP-protocol patients were readmitted within 72 hours of discharge. The researchers estimated that the 640 patients in the POP protocol saved approximately 1892.27 hours of nursing and 705.1 provider hours during the study period, and no additional physician hours or advanced-practice provider hours were needed.

The study findings suggest that POP holds up as a safe, efficient, and effective process that can reduce discharge length of stay and provider to disposition times. Although more research is needed, the POP model also may be considered to address staffing challenges unrelated to the pandemic, the researchers concluded.

“This study was conducted at [a] time when our emergency department was experiencing a sudden and disproportionate increase in volume related to the Omicron variant of COVID-19,” Dr. Gaibi told this news organization. “This novel process was developed by brainstorming untested ways of managing this increased demand. The research study was a natural outcome once the process was implemented,” he said.

“Once barriers to implementing this process were overcome, we were not surprised by the results,” Dr. Gaibi said. “Subtracting at the time for nursing process was anticipated to shorten cycle times.”

The clinical implications of POP relate to generalizability outside of the pandemic setting, Dr. Gaibi noted. “We anticipate that POP could be used for patients with minor complaints to greatly shorten their time in the emergency department,” he said.

“Potential barriers to the generalized use of POP relate, in part, to local administrative barriers related to nursing assessments,” Dr. Gaibi explained. “Further, POP patients should be simple and require little or no testing. Keeping to this strict definition of the provider-only patient may be a pitfall in terms of its hard wiring,” he added.

Looking ahead, more research is needed to study POP in ED patients with minor complaints not necessarily related to COVID-19, Dr. Gaibi said.

The study received no outside funding. The researchers disclosed no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Sepsis is among the most feared conditions for health care providers. These blood infections strike with such rapid intensity that treating them demands a mix of both clinical skill and luck – recognizing symptoms early enough while choosing the right drug to tame the bacterial culprit before the germs have overwhelmed the body’s immune system.

All too often, sepsis wins the race. According to the U.S. Centers for Disease Control and Prevention, at least 1.7 million people in this country develop sepsis annually. About 350,000 die during hospitalization or are discharged to hospice.

But new research, published in Proceedings of the National Academy of Sciences, offers hope that clinicians may one day be able to detect and treat sepsis more quickly.

The researchers broke down whole blood and dried it by heating, resulting in a solid porous structure with the bacterial DNA trapped inside. They then used chemicals – primers and enzymes – to reach inside the porous structure and amplify the target DNA.

The team was able to detect four causes of bloodstream infections – the bacteria methicillin-resistant Staphylococcus aureus (MRSA), methicillin-susceptible Staphylococcus aureus (MSSA), gram-negative Escherichia coli, and the fungal species Candida albicans. They validated their method against clinical laboratory results that used blood cultures and DNA analyses to detect sepsis.

The technique took just 2.5 hours and required roughly 1 mL of blood, according to the researchers.

“This technique can have broad applications in detection of bacterial infection and presence of bacteria in large values of blood,” Rashid Bashir, PhD, dean of the University of Illinois at Urbana-Champaign’s Grainger College of Engineering, and a co-author of the study, told this news organization.

While infection control experts and sepsis prevention advocates said the new study offers no clues about how to treat sepsis once detected, they hope the innovation eventually could save lives.
 

A rapid killer

Sepsis occurs when the body overreacts to an infection. The severe response can lead to tissue damage, organ failure, and death.

Thomas Heymann, MBA, president and CEO of Sepsis Alliance, an advocacy group, said mortality can rise 8% for each hour treatment is delayed.

Infants born prematurely are particularly vulnerable. Dr. Bashir and his colleagues noted that 25% of all infants admitted to the neonatal intensive care unit are diagnosed with sepsis. Of those, as many as 35% may die from infection. Sepsis is the most expensive condition treated in U.S. hospitals, accounting for $23.7 billion in costs annually, they added.

Despite high mortality rates and hospital costs, according to a Sepsis Alliance survey, only 66% of Americans are aware of the term sepsis. Only 19% can name the four primary signs of the condition: Altered body Temperature, an Infection, Mental decline, and feeling Extremely ill, or “TIME.”

Getting the appropriate antibiotics to sepsis patients quickly can greatly improve chances of survival, but Dr. Bashir said the current method of confirming the diagnosis is too slow.
 

Blood cultures too slow

Traditional blood cultures are among the most common methods of determining if a patient has a bloodstream infection. But the process takes about 24 hours for a culture to detect the category of bacteria and an additional day to determine exactly which bacteria is present, according to Cindy Hou, DO, infection control officer and medical director of research at Jefferson Health, Voorhees Township, New Jersey. At 72 hours, Dr. Hou said, a blood culture will finally be able to produce a “sensitivity” result, which tells doctors which antibiotics will be most effective against the pathogen.

By then, patients often are already past the point of saving. The bottom line, according to Dr. Bashir and his colleagues: Blood cultures are “too slow and cumbersome to allow for initial management of patients and thus contribute to high mortality.”

Dr. Hou called the ability to identify the type of infection in just 2.5 hours an “amazing” feat.

“With sepsis, it is helpful to have rapid diagnostics where results come back quickly. Rapid is never rapid enough,” she said. “These researchers are pushing the bar for what rapid means.”

The new detection method is not yet available commercially. Dr. Bashir said he and his colleagues plan to scale their study and hope to find a way to bypass the long culture steps to identify target pathogens directly from a large volume of blood.

Dr. Hou said she believes a blood culture would still be necessary since clinicians would need sensitivity results to guide targeted treatment of infections.

“There is a lot more we need, but this paper is a call to arms for the field of rapid diagnostics to make rapid as fast as it really needs to be, but we still need to find solutions which are affordable,” Dr. Hou said.

Even without a blood culture, Dr. Bashir’s technology could improve care. Mr. Heymann said the technology could help convince clinicians worried about antibiotic resistance to prescribe treatment faster.

“We know we’re overusing antibiotics, and that’s creating a new big problem” when it comes to sepsis treatment, he said. “Getting a diagnostic read earlier is a game changer.”

Combined with a blood culture that can later confirm or help adjust the course of treatment, Dr. Hou said this new method of sepsis detection could improve care, especially in places where rapid diagnostics are not available and particularly if combined with physician education so they understand what treatment is best for various types of infection. 

Mr. Heymann agreed. Sepsis Alliance also operates the Sepsis Innovation Collaborative, a group that supports public-private innovation on sepsis care.

“We’re losing someone every 90 seconds in the United States to sepsis,” Mr. Heymann said. “There is a huge opportunity to do better, and it’s this kind of innovation that is really inspiring.”

Dr. Hou is chief medical officer for Sepsis Alliance, a medical advisor for the Sepsis Innovation Collaborative, an advisor for Janssen, and a key opinion leader for T2 Biosystems. Dr. Bashir and Mr. Heymann report no relevant financial relationships.

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

Monthly injections of dupilumab significantly improved symptoms of moderate to severe atopic dermatitis (AD) in children aged 6 months to under 6 years after 16 weeks, in a study of 162 children at 31 treatment centers in North America and Europe.

Children younger than 6 years with moderate to severe AD have few options if their symptoms are uncontrolled with topical therapies, and persistent itchiness has a negative impact on quality of life for patients and families, Amy S. Paller, MD, professor and chair of dermatology, and professor of pediatrics at Northwestern University, Chicago, and colleagues wrote in the study, published in the Lancet.

The study was the basis of the Food and Drug Administration expanded approval of dupilumab in June 2022, to include children aged 6 months to 5 years with moderate to severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Regulatory submission for this age group is under review by the European Medicines Agency, and by regulatory authorities in other countries, according to the manufacturers.

Dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, was first approved in 2017 for treating adults with moderate to severe AD.

“There has not been a biologic approved before at such a young age, and for such a common disease,” Dr. Paller said in an interview. “This is the drug that has revolutionized care of the most common inflammatory skin disease in children, and this is the pivotal study that brought it to market for the youngest children who suffer from the severe forms.”

The study also sets a precedent for a lower threshold for starting systemic medication in young children for treating moderate to severe disease given the absence of severe side effects and no need for lab monitoring, Dr. Paller noted. However, dupilumab will also be closely watched “for both impact on the developing immune system and the possibility that it will alter the long-term course of the eczema and the development of allergic comorbidities, such as lowering the risk of developing asthma, GI, allergy, and possibly other conditions.”

In the study, the researchers randomized 83 children aged 6 months up to 6 years to treatment with dupilumab, administered subcutaneously, and 79 to placebo every 4 weeks for 16 weeks; both groups also received topical corticosteroids. Dosage of dupilumab was based on body weight; those with a body weight of 5-15 kg received 200 mg, while those with a body weight of 15-30 kg received 300 mg. The primary endpoint was the proportion of patients with clear or almost clear skin at 16 weeks, defined as scores of 0 or 1 on the Investigator’s Global Assessment.

After 16 weeks, 28% of dupilumab patients met the primary endpoint versus 4% of those on placebo (P < .0001). In addition, 53% of dupilumab patients met the key secondary endpoint of a 75% improvement from baseline in Eczema Area and Severity Index, compared with 11% of patients on placebo (P < .0001). Treatment with dupilumab also resulted in significantly greater improvements in pruritus and skin pain, and sleep quality, as well as improved quality of life for patients and their caregivers, the authors reported.

Overall, adverse event rates were slightly lower in the dupilumab-treated patients, compared with patients on placebo (64% vs. 74%); there were no adverse events related to dupilumab that were serious or resulted in treatment discontinuation. Treatment-emergent adverse effects that were reported in 3% or more of patients and affected more of those on dupilumab than those on placebo included molluscum contagiosum (5% vs. 3%), viral gastroenteritis (4% vs. 0), rhinorrhea (5% vs. 1%), dental caries (5% vs. 0), and conjunctivitis (4% vs 0).

The rate of skin infections among the children on dupilumab was 12% vs. 24% among those on placebo.

Severe and treatment-related adverse events also were similar in both subgroups of body weight.

The findings were limited by the small number of patients younger than 2 years and the lack of study sites outside of North America and Europe, the researchers noted. However, the results were strengthened by the randomized, double-blind design and use of background topical therapy to provide a real-world safety and efficacy assessment in a very young population.
 

Overcoming injection issues

The safety profile for dupilumab, which is of the highest importance, “did not surprise me at all,” Dr. Paller said in an interview. “My only surprise is that the placebo injections actually led to more injection site reactions than [with] dupilumab, but numbers were quite low in both groups.” (Rates were 2% among those on dupilumab and 3% among those on placebo.)

The major barrier to the use of dupilumab in clinical practice is the requirement for injection, which, she explained, can be “unbearable for some young children, and thus becomes impossible for parents because of lack of cooperation and their intensified concern about giving the injection,” because of their child’s response.

“We like to administer the first dose in the office, allowing us to teach parents a few tricks related to proper technique,” including audio and visual distraction, tactile stimulation before and during the injection, use of topical anesthetic if helpful, “and making sure that the medication is at room temperature before administration,” she said. Cost is another potential barrier; however, even public insurance has been covering the medication, often after optimized use of topical medications has been unsuccessful.
 

Future research questions

As for additional research, the current study had a relatively small number of patients younger than 2 years, and more data are needed for this age group, said Dr. Paller. “We also need better understanding of the safety of dupilumab administration when live vaccines are administered. Finally, we certainly want to know what additional effects dupilumab may have beyond just the efficacy for treating eczema.”

In particular, these questions include whether dupilumab modifies the long-term course of the disease, possibly reducing the risk of persistence of disease with advancing age, or even cures the disease if started at a young age, she said. In addition, research has yet to show whether dupilumab might reduce the risk of other atopic disorders, such as asthma, food allergy, and allergic rhinitis.

“Ongoing studies and real-life experiences in the next several years will help us to answer these questions,” Dr. Paller said.
 

Data support safety, efficacy, quality of life

AD is associated with immense quality of life impairment, Raj Chovatiya, MD, of Northwestern University, Chicago, said in an interview. Most AD is initially diagnosed in early childhood, but previous treatment options for those with moderate to severe disease have been limited by safety concerns, which adds to the burden on infants and young children, and their parents and caregivers, said Dr. Chovatiya, who was not involved in the study.

“This phase 3 study showed that dupilumab, a fully human monoclonal antibody that selectively inhibits IL-4 and IL-13 mediated type 2 inflammatory signaling, provided both meaningful and statistically significant improvement in AD severity, extent of disease, and itch in patients,” he said. Dupilumab also improved children’s sleep quality and the overall quality of life in both patients and caregivers.

“These findings were quite similar to those described in older children and adults, where dupilumab is already approved for the treatment of moderate-severe AD and has demonstrated real-world safety and efficacy,” said Dr. Chovatiya. However, “the current study was limited to only a short-term analysis of 16 weeks, an ongoing open-label study should further address long-term treatment responses.”

The study was supported by Sanofi and Regeneron Pharmaceuticals. In addition to being an investigator for Regeneron, and several other pharmaceutical companies, Dr. Paller has been a consultant with honorarium for Regeneron, Sanofi, and multiple other companies. Dr. Chovatiya disclosed serving as a consultant and speaker for Regeneron and Sanofi, but was not involved in the current study.

Monthly injections of dupilumab significantly improved symptoms of moderate to severe atopic dermatitis (AD) in children aged 6 months to under 6 years after 16 weeks, in a study of 162 children at 31 treatment centers in North America and Europe.

Children younger than 6 years with moderate to severe AD have few options if their symptoms are uncontrolled with topical therapies, and persistent itchiness has a negative impact on quality of life for patients and families, Amy S. Paller, MD, professor and chair of dermatology, and professor of pediatrics at Northwestern University, Chicago, and colleagues wrote in the study, published in the Lancet.

The study was the basis of the Food and Drug Administration expanded approval of dupilumab in June 2022, to include children aged 6 months to 5 years with moderate to severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Regulatory submission for this age group is under review by the European Medicines Agency, and by regulatory authorities in other countries, according to the manufacturers.

Dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, was first approved in 2017 for treating adults with moderate to severe AD.

“There has not been a biologic approved before at such a young age, and for such a common disease,” Dr. Paller said in an interview. “This is the drug that has revolutionized care of the most common inflammatory skin disease in children, and this is the pivotal study that brought it to market for the youngest children who suffer from the severe forms.”

The study also sets a precedent for a lower threshold for starting systemic medication in young children for treating moderate to severe disease given the absence of severe side effects and no need for lab monitoring, Dr. Paller noted. However, dupilumab will also be closely watched “for both impact on the developing immune system and the possibility that it will alter the long-term course of the eczema and the development of allergic comorbidities, such as lowering the risk of developing asthma, GI, allergy, and possibly other conditions.”

In the study, the researchers randomized 83 children aged 6 months up to 6 years to treatment with dupilumab, administered subcutaneously, and 79 to placebo every 4 weeks for 16 weeks; both groups also received topical corticosteroids. Dosage of dupilumab was based on body weight; those with a body weight of 5-15 kg received 200 mg, while those with a body weight of 15-30 kg received 300 mg. The primary endpoint was the proportion of patients with clear or almost clear skin at 16 weeks, defined as scores of 0 or 1 on the Investigator’s Global Assessment.

After 16 weeks, 28% of dupilumab patients met the primary endpoint versus 4% of those on placebo (P < .0001). In addition, 53% of dupilumab patients met the key secondary endpoint of a 75% improvement from baseline in Eczema Area and Severity Index, compared with 11% of patients on placebo (P < .0001). Treatment with dupilumab also resulted in significantly greater improvements in pruritus and skin pain, and sleep quality, as well as improved quality of life for patients and their caregivers, the authors reported.

Overall, adverse event rates were slightly lower in the dupilumab-treated patients, compared with patients on placebo (64% vs. 74%); there were no adverse events related to dupilumab that were serious or resulted in treatment discontinuation. Treatment-emergent adverse effects that were reported in 3% or more of patients and affected more of those on dupilumab than those on placebo included molluscum contagiosum (5% vs. 3%), viral gastroenteritis (4% vs. 0), rhinorrhea (5% vs. 1%), dental caries (5% vs. 0), and conjunctivitis (4% vs 0).

The rate of skin infections among the children on dupilumab was 12% vs. 24% among those on placebo.

Severe and treatment-related adverse events also were similar in both subgroups of body weight.

The findings were limited by the small number of patients younger than 2 years and the lack of study sites outside of North America and Europe, the researchers noted. However, the results were strengthened by the randomized, double-blind design and use of background topical therapy to provide a real-world safety and efficacy assessment in a very young population.
 

Overcoming injection issues

The safety profile for dupilumab, which is of the highest importance, “did not surprise me at all,” Dr. Paller said in an interview. “My only surprise is that the placebo injections actually led to more injection site reactions than [with] dupilumab, but numbers were quite low in both groups.” (Rates were 2% among those on dupilumab and 3% among those on placebo.)

The major barrier to the use of dupilumab in clinical practice is the requirement for injection, which, she explained, can be “unbearable for some young children, and thus becomes impossible for parents because of lack of cooperation and their intensified concern about giving the injection,” because of their child’s response.

“We like to administer the first dose in the office, allowing us to teach parents a few tricks related to proper technique,” including audio and visual distraction, tactile stimulation before and during the injection, use of topical anesthetic if helpful, “and making sure that the medication is at room temperature before administration,” she said. Cost is another potential barrier; however, even public insurance has been covering the medication, often after optimized use of topical medications has been unsuccessful.
 

Future research questions

As for additional research, the current study had a relatively small number of patients younger than 2 years, and more data are needed for this age group, said Dr. Paller. “We also need better understanding of the safety of dupilumab administration when live vaccines are administered. Finally, we certainly want to know what additional effects dupilumab may have beyond just the efficacy for treating eczema.”

In particular, these questions include whether dupilumab modifies the long-term course of the disease, possibly reducing the risk of persistence of disease with advancing age, or even cures the disease if started at a young age, she said. In addition, research has yet to show whether dupilumab might reduce the risk of other atopic disorders, such as asthma, food allergy, and allergic rhinitis.

“Ongoing studies and real-life experiences in the next several years will help us to answer these questions,” Dr. Paller said.
 

Data support safety, efficacy, quality of life

AD is associated with immense quality of life impairment, Raj Chovatiya, MD, of Northwestern University, Chicago, said in an interview. Most AD is initially diagnosed in early childhood, but previous treatment options for those with moderate to severe disease have been limited by safety concerns, which adds to the burden on infants and young children, and their parents and caregivers, said Dr. Chovatiya, who was not involved in the study.

“This phase 3 study showed that dupilumab, a fully human monoclonal antibody that selectively inhibits IL-4 and IL-13 mediated type 2 inflammatory signaling, provided both meaningful and statistically significant improvement in AD severity, extent of disease, and itch in patients,” he said. Dupilumab also improved children’s sleep quality and the overall quality of life in both patients and caregivers.

“These findings were quite similar to those described in older children and adults, where dupilumab is already approved for the treatment of moderate-severe AD and has demonstrated real-world safety and efficacy,” said Dr. Chovatiya. However, “the current study was limited to only a short-term analysis of 16 weeks, an ongoing open-label study should further address long-term treatment responses.”

The study was supported by Sanofi and Regeneron Pharmaceuticals. In addition to being an investigator for Regeneron, and several other pharmaceutical companies, Dr. Paller has been a consultant with honorarium for Regeneron, Sanofi, and multiple other companies. Dr. Chovatiya disclosed serving as a consultant and speaker for Regeneron and Sanofi, but was not involved in the current study.

Monthly injections of dupilumab significantly improved symptoms of moderate to severe atopic dermatitis (AD) in children aged 6 months to under 6 years after 16 weeks, in a study of 162 children at 31 treatment centers in North America and Europe.

Children younger than 6 years with moderate to severe AD have few options if their symptoms are uncontrolled with topical therapies, and persistent itchiness has a negative impact on quality of life for patients and families, Amy S. Paller, MD, professor and chair of dermatology, and professor of pediatrics at Northwestern University, Chicago, and colleagues wrote in the study, published in the Lancet.

The study was the basis of the Food and Drug Administration expanded approval of dupilumab in June 2022, to include children aged 6 months to 5 years with moderate to severe AD, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Regulatory submission for this age group is under review by the European Medicines Agency, and by regulatory authorities in other countries, according to the manufacturers.

Dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, was first approved in 2017 for treating adults with moderate to severe AD.

“There has not been a biologic approved before at such a young age, and for such a common disease,” Dr. Paller said in an interview. “This is the drug that has revolutionized care of the most common inflammatory skin disease in children, and this is the pivotal study that brought it to market for the youngest children who suffer from the severe forms.”

The study also sets a precedent for a lower threshold for starting systemic medication in young children for treating moderate to severe disease given the absence of severe side effects and no need for lab monitoring, Dr. Paller noted. However, dupilumab will also be closely watched “for both impact on the developing immune system and the possibility that it will alter the long-term course of the eczema and the development of allergic comorbidities, such as lowering the risk of developing asthma, GI, allergy, and possibly other conditions.”

In the study, the researchers randomized 83 children aged 6 months up to 6 years to treatment with dupilumab, administered subcutaneously, and 79 to placebo every 4 weeks for 16 weeks; both groups also received topical corticosteroids. Dosage of dupilumab was based on body weight; those with a body weight of 5-15 kg received 200 mg, while those with a body weight of 15-30 kg received 300 mg. The primary endpoint was the proportion of patients with clear or almost clear skin at 16 weeks, defined as scores of 0 or 1 on the Investigator’s Global Assessment.

After 16 weeks, 28% of dupilumab patients met the primary endpoint versus 4% of those on placebo (P < .0001). In addition, 53% of dupilumab patients met the key secondary endpoint of a 75% improvement from baseline in Eczema Area and Severity Index, compared with 11% of patients on placebo (P < .0001). Treatment with dupilumab also resulted in significantly greater improvements in pruritus and skin pain, and sleep quality, as well as improved quality of life for patients and their caregivers, the authors reported.

Overall, adverse event rates were slightly lower in the dupilumab-treated patients, compared with patients on placebo (64% vs. 74%); there were no adverse events related to dupilumab that were serious or resulted in treatment discontinuation. Treatment-emergent adverse effects that were reported in 3% or more of patients and affected more of those on dupilumab than those on placebo included molluscum contagiosum (5% vs. 3%), viral gastroenteritis (4% vs. 0), rhinorrhea (5% vs. 1%), dental caries (5% vs. 0), and conjunctivitis (4% vs 0).

The rate of skin infections among the children on dupilumab was 12% vs. 24% among those on placebo.

Severe and treatment-related adverse events also were similar in both subgroups of body weight.

The findings were limited by the small number of patients younger than 2 years and the lack of study sites outside of North America and Europe, the researchers noted. However, the results were strengthened by the randomized, double-blind design and use of background topical therapy to provide a real-world safety and efficacy assessment in a very young population.
 

Overcoming injection issues

The safety profile for dupilumab, which is of the highest importance, “did not surprise me at all,” Dr. Paller said in an interview. “My only surprise is that the placebo injections actually led to more injection site reactions than [with] dupilumab, but numbers were quite low in both groups.” (Rates were 2% among those on dupilumab and 3% among those on placebo.)

The major barrier to the use of dupilumab in clinical practice is the requirement for injection, which, she explained, can be “unbearable for some young children, and thus becomes impossible for parents because of lack of cooperation and their intensified concern about giving the injection,” because of their child’s response.

“We like to administer the first dose in the office, allowing us to teach parents a few tricks related to proper technique,” including audio and visual distraction, tactile stimulation before and during the injection, use of topical anesthetic if helpful, “and making sure that the medication is at room temperature before administration,” she said. Cost is another potential barrier; however, even public insurance has been covering the medication, often after optimized use of topical medications has been unsuccessful.
 

Future research questions

As for additional research, the current study had a relatively small number of patients younger than 2 years, and more data are needed for this age group, said Dr. Paller. “We also need better understanding of the safety of dupilumab administration when live vaccines are administered. Finally, we certainly want to know what additional effects dupilumab may have beyond just the efficacy for treating eczema.”

In particular, these questions include whether dupilumab modifies the long-term course of the disease, possibly reducing the risk of persistence of disease with advancing age, or even cures the disease if started at a young age, she said. In addition, research has yet to show whether dupilumab might reduce the risk of other atopic disorders, such as asthma, food allergy, and allergic rhinitis.

“Ongoing studies and real-life experiences in the next several years will help us to answer these questions,” Dr. Paller said.
 

Data support safety, efficacy, quality of life

AD is associated with immense quality of life impairment, Raj Chovatiya, MD, of Northwestern University, Chicago, said in an interview. Most AD is initially diagnosed in early childhood, but previous treatment options for those with moderate to severe disease have been limited by safety concerns, which adds to the burden on infants and young children, and their parents and caregivers, said Dr. Chovatiya, who was not involved in the study.

“This phase 3 study showed that dupilumab, a fully human monoclonal antibody that selectively inhibits IL-4 and IL-13 mediated type 2 inflammatory signaling, provided both meaningful and statistically significant improvement in AD severity, extent of disease, and itch in patients,” he said. Dupilumab also improved children’s sleep quality and the overall quality of life in both patients and caregivers.

“These findings were quite similar to those described in older children and adults, where dupilumab is already approved for the treatment of moderate-severe AD and has demonstrated real-world safety and efficacy,” said Dr. Chovatiya. However, “the current study was limited to only a short-term analysis of 16 weeks, an ongoing open-label study should further address long-term treatment responses.”

The study was supported by Sanofi and Regeneron Pharmaceuticals. In addition to being an investigator for Regeneron, and several other pharmaceutical companies, Dr. Paller has been a consultant with honorarium for Regeneron, Sanofi, and multiple other companies. Dr. Chovatiya disclosed serving as a consultant and speaker for Regeneron and Sanofi, but was not involved in the current study.

Men who have sex with men have an increased prevalence of inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, according to a new report.

In particular, those with high-risk sexual activity, such as engaging in unprotected sex or having multiple sexual partners, were more likely to have IBD diagnoses than were men who have sex with women who also have high-risk sexual activity.

“Underrepresented sex and gender minorities have less access to health care in general for multiple reasons, and when it comes to gastrointestinal issues, such as IBD, there may be a certain level of shame when going to a doctor or clinic,” senior author Fabio Cominelli, MD, PhD, told this news organization. Dr. Cominelli is professor of medicine and pathology at Case Western Reserve University and the chief scientific officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center.

“Our overall goal is to improve access to health care so people can access all of the resources available,” he said. “If we can learn more about the pathogenesis, or cause of the disease, we can help with diagnosis and treatment.”

The study was published online in the BMJ journal Gut.
 

Assessing prevalence

The prevalence and natural history of IBD hasn’t been reported for lesbian, gay, bisexual, transgender, queer, intersex, and asexual populations, the study authors wrote. As of 2022, 7% of Americans identify as LGBTQIA+, up from 5.6% in 2020, according to a Gallup poll from earlier this year highlighting the importance of understanding the epidemiology of IBD for these patients.

Dr. Cominelli and colleagues analyzed data from TriNetX, a large population-based health research network, to evaluate the prevalence of Crohn’s disease and ulcerative colitis in LGBTQIA+ groups between 2002 and 2022. They first identified adult patients based on self-reported sexual orientation, and then further defined those with a diagnostic code of high-risk sexual activity.

Among 11,845 people with high-risk, same-sex sexual activity, 91 (0.77%) were diagnosed with Crohn’s disease and 148 (1.3%) were diagnosed with ulcerative colitis. About 91% were men, and among those who have sex with men, 86 people (0.8%) were diagnosed with Crohn’s disease and 136 people (1.3%) were diagnosed with ulcerative colitis.

Among the 498 women with high-risk, same-sex sexual activity, 5 were diagnosed with Crohn’s disease and 8 were diagnosed with ulcerative colitis. The research team excluded women from the analysis because of a lack of statistical power.

Among the 60,755 men who have sex with women with high-risk sexual activity, 298 (0.49%) had Crohn’s disease and 314 (0.52%) had ulcerative colitis.

Overall, men who have high-risk sex with men were nearly 2.5 times more likely to be diagnosed with ulcerative colitis and 64% more likely to be diagnosed with Crohn’s disease.

“We hope this retrospective study provides a starting point for us and others to do prospective studies where we enroll patients and more closely investigate this idea,” Dr. Cominelli said. “Our goal is to develop personalized precision therapy for patients.”
 

Hypotheses accounting for the higher prevalence

Dr. Cominelli and colleagues have received grants from the National Institutes of Health to confirm the increased prevalence of IBD in men who have sex with men, as well as the association between specific sexual practices and the risk of developing Crohn’s disease or ulcerative colitis.

They’re also investigating the potential role of the gut microbiome, with the aim of developing interventions for patients.

“One hypothesis is that sexual preferences and practices – such as anal sex or oral sex – can predispose people to specific infections,” Dr. Cominelli said. “Some studies, especially among HIV patients, have provided some preliminary evidence that the gut microbiome can be different and may play a role in IBD, which can affect the prevalence of disease.”

For instance, previous studies have shown that men who have sex with men predominantly have a Prevotella-rich enterotype, whereas other groups have a Bacteroides-rich enterotype. Men who have sex with men also have a significantly richer and more diverse fecal microbiome composition, the study authors wrote.

In addition, researchers and clinicians should consider the possibility of sexual transmission of specific fecal organisms between men who have sex with men, they noted. Several studies have found an increased prevalence of invasive infections by Entamoeba histolytica, Shigella, Cryptosporidia, and Campylobacter among men who have sex with men.
 

Future studies needed to address limitations

Even still, additional studies are needed to understand the prevalence rates of IBD among LGBTQIA+ patients and how certain sexual practices may influence the gut microbiome, Adam Ehrlich, MD, associate professor of medicine at Temple University, Philadelphia, told this news organization.

“The challenge here is that using a large database has lots of challenges with bias,” he said. “For example, there are very small numbers of LGBTQIA+ patients with IBD in this analysis, there is no specific definition for ‘high-risk activity’ for either homosexual or heterosexual practices, and racial breakdown includes many of unknown race.”

Dr. Ehrlich, who also serves as co-medical director of Temple University Hospital’s inflammatory bowel disease program, is one of the gender-affirming gastroenterologists at the hospital.

“These database studies are often good to generate hypotheses that can be better analyzed with a cohort of patients that you know more about,” Dr. Ehrlich said. “Are patients who identify as LGBTQIA+ more susceptible to IBD? If so, what would the mechanism be? Further study is needed, as they suggest.”

The study was supported by the Clinical Component of the Administrative Core of the NIH Cleveland Digestive Diseases Research Core Center and administrative supplement from the National Institute of Diabetes and Digestive and Kidney Diseases and Sexual and Gender Minority Research Office. The authors and Dr. Ehrlich report no relevant financial relationships.

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

Men who have sex with men have an increased prevalence of inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, according to a new report.

In particular, those with high-risk sexual activity, such as engaging in unprotected sex or having multiple sexual partners, were more likely to have IBD diagnoses than were men who have sex with women who also have high-risk sexual activity.

“Underrepresented sex and gender minorities have less access to health care in general for multiple reasons, and when it comes to gastrointestinal issues, such as IBD, there may be a certain level of shame when going to a doctor or clinic,” senior author Fabio Cominelli, MD, PhD, told this news organization. Dr. Cominelli is professor of medicine and pathology at Case Western Reserve University and the chief scientific officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center.

“Our overall goal is to improve access to health care so people can access all of the resources available,” he said. “If we can learn more about the pathogenesis, or cause of the disease, we can help with diagnosis and treatment.”

The study was published online in the BMJ journal Gut.
 

Assessing prevalence

The prevalence and natural history of IBD hasn’t been reported for lesbian, gay, bisexual, transgender, queer, intersex, and asexual populations, the study authors wrote. As of 2022, 7% of Americans identify as LGBTQIA+, up from 5.6% in 2020, according to a Gallup poll from earlier this year highlighting the importance of understanding the epidemiology of IBD for these patients.

Dr. Cominelli and colleagues analyzed data from TriNetX, a large population-based health research network, to evaluate the prevalence of Crohn’s disease and ulcerative colitis in LGBTQIA+ groups between 2002 and 2022. They first identified adult patients based on self-reported sexual orientation, and then further defined those with a diagnostic code of high-risk sexual activity.

Among 11,845 people with high-risk, same-sex sexual activity, 91 (0.77%) were diagnosed with Crohn’s disease and 148 (1.3%) were diagnosed with ulcerative colitis. About 91% were men, and among those who have sex with men, 86 people (0.8%) were diagnosed with Crohn’s disease and 136 people (1.3%) were diagnosed with ulcerative colitis.

Among the 498 women with high-risk, same-sex sexual activity, 5 were diagnosed with Crohn’s disease and 8 were diagnosed with ulcerative colitis. The research team excluded women from the analysis because of a lack of statistical power.

Among the 60,755 men who have sex with women with high-risk sexual activity, 298 (0.49%) had Crohn’s disease and 314 (0.52%) had ulcerative colitis.

Overall, men who have high-risk sex with men were nearly 2.5 times more likely to be diagnosed with ulcerative colitis and 64% more likely to be diagnosed with Crohn’s disease.

“We hope this retrospective study provides a starting point for us and others to do prospective studies where we enroll patients and more closely investigate this idea,” Dr. Cominelli said. “Our goal is to develop personalized precision therapy for patients.”
 

Hypotheses accounting for the higher prevalence

Dr. Cominelli and colleagues have received grants from the National Institutes of Health to confirm the increased prevalence of IBD in men who have sex with men, as well as the association between specific sexual practices and the risk of developing Crohn’s disease or ulcerative colitis.

They’re also investigating the potential role of the gut microbiome, with the aim of developing interventions for patients.

“One hypothesis is that sexual preferences and practices – such as anal sex or oral sex – can predispose people to specific infections,” Dr. Cominelli said. “Some studies, especially among HIV patients, have provided some preliminary evidence that the gut microbiome can be different and may play a role in IBD, which can affect the prevalence of disease.”

For instance, previous studies have shown that men who have sex with men predominantly have a Prevotella-rich enterotype, whereas other groups have a Bacteroides-rich enterotype. Men who have sex with men also have a significantly richer and more diverse fecal microbiome composition, the study authors wrote.

In addition, researchers and clinicians should consider the possibility of sexual transmission of specific fecal organisms between men who have sex with men, they noted. Several studies have found an increased prevalence of invasive infections by Entamoeba histolytica, Shigella, Cryptosporidia, and Campylobacter among men who have sex with men.
 

Future studies needed to address limitations

Even still, additional studies are needed to understand the prevalence rates of IBD among LGBTQIA+ patients and how certain sexual practices may influence the gut microbiome, Adam Ehrlich, MD, associate professor of medicine at Temple University, Philadelphia, told this news organization.

“The challenge here is that using a large database has lots of challenges with bias,” he said. “For example, there are very small numbers of LGBTQIA+ patients with IBD in this analysis, there is no specific definition for ‘high-risk activity’ for either homosexual or heterosexual practices, and racial breakdown includes many of unknown race.”

Dr. Ehrlich, who also serves as co-medical director of Temple University Hospital’s inflammatory bowel disease program, is one of the gender-affirming gastroenterologists at the hospital.

“These database studies are often good to generate hypotheses that can be better analyzed with a cohort of patients that you know more about,” Dr. Ehrlich said. “Are patients who identify as LGBTQIA+ more susceptible to IBD? If so, what would the mechanism be? Further study is needed, as they suggest.”

The study was supported by the Clinical Component of the Administrative Core of the NIH Cleveland Digestive Diseases Research Core Center and administrative supplement from the National Institute of Diabetes and Digestive and Kidney Diseases and Sexual and Gender Minority Research Office. The authors and Dr. Ehrlich report no relevant financial relationships.

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

Men who have sex with men have an increased prevalence of inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, according to a new report.

In particular, those with high-risk sexual activity, such as engaging in unprotected sex or having multiple sexual partners, were more likely to have IBD diagnoses than were men who have sex with women who also have high-risk sexual activity.

“Underrepresented sex and gender minorities have less access to health care in general for multiple reasons, and when it comes to gastrointestinal issues, such as IBD, there may be a certain level of shame when going to a doctor or clinic,” senior author Fabio Cominelli, MD, PhD, told this news organization. Dr. Cominelli is professor of medicine and pathology at Case Western Reserve University and the chief scientific officer of the Digestive Health Institute at University Hospitals Cleveland Medical Center.

“Our overall goal is to improve access to health care so people can access all of the resources available,” he said. “If we can learn more about the pathogenesis, or cause of the disease, we can help with diagnosis and treatment.”

The study was published online in the BMJ journal Gut.
 

Assessing prevalence

The prevalence and natural history of IBD hasn’t been reported for lesbian, gay, bisexual, transgender, queer, intersex, and asexual populations, the study authors wrote. As of 2022, 7% of Americans identify as LGBTQIA+, up from 5.6% in 2020, according to a Gallup poll from earlier this year highlighting the importance of understanding the epidemiology of IBD for these patients.

Dr. Cominelli and colleagues analyzed data from TriNetX, a large population-based health research network, to evaluate the prevalence of Crohn’s disease and ulcerative colitis in LGBTQIA+ groups between 2002 and 2022. They first identified adult patients based on self-reported sexual orientation, and then further defined those with a diagnostic code of high-risk sexual activity.

Among 11,845 people with high-risk, same-sex sexual activity, 91 (0.77%) were diagnosed with Crohn’s disease and 148 (1.3%) were diagnosed with ulcerative colitis. About 91% were men, and among those who have sex with men, 86 people (0.8%) were diagnosed with Crohn’s disease and 136 people (1.3%) were diagnosed with ulcerative colitis.

Among the 498 women with high-risk, same-sex sexual activity, 5 were diagnosed with Crohn’s disease and 8 were diagnosed with ulcerative colitis. The research team excluded women from the analysis because of a lack of statistical power.

Among the 60,755 men who have sex with women with high-risk sexual activity, 298 (0.49%) had Crohn’s disease and 314 (0.52%) had ulcerative colitis.

Overall, men who have high-risk sex with men were nearly 2.5 times more likely to be diagnosed with ulcerative colitis and 64% more likely to be diagnosed with Crohn’s disease.

“We hope this retrospective study provides a starting point for us and others to do prospective studies where we enroll patients and more closely investigate this idea,” Dr. Cominelli said. “Our goal is to develop personalized precision therapy for patients.”
 

Hypotheses accounting for the higher prevalence

Dr. Cominelli and colleagues have received grants from the National Institutes of Health to confirm the increased prevalence of IBD in men who have sex with men, as well as the association between specific sexual practices and the risk of developing Crohn’s disease or ulcerative colitis.

They’re also investigating the potential role of the gut microbiome, with the aim of developing interventions for patients.

“One hypothesis is that sexual preferences and practices – such as anal sex or oral sex – can predispose people to specific infections,” Dr. Cominelli said. “Some studies, especially among HIV patients, have provided some preliminary evidence that the gut microbiome can be different and may play a role in IBD, which can affect the prevalence of disease.”

For instance, previous studies have shown that men who have sex with men predominantly have a Prevotella-rich enterotype, whereas other groups have a Bacteroides-rich enterotype. Men who have sex with men also have a significantly richer and more diverse fecal microbiome composition, the study authors wrote.

In addition, researchers and clinicians should consider the possibility of sexual transmission of specific fecal organisms between men who have sex with men, they noted. Several studies have found an increased prevalence of invasive infections by Entamoeba histolytica, Shigella, Cryptosporidia, and Campylobacter among men who have sex with men.
 

Future studies needed to address limitations

Even still, additional studies are needed to understand the prevalence rates of IBD among LGBTQIA+ patients and how certain sexual practices may influence the gut microbiome, Adam Ehrlich, MD, associate professor of medicine at Temple University, Philadelphia, told this news organization.

“The challenge here is that using a large database has lots of challenges with bias,” he said. “For example, there are very small numbers of LGBTQIA+ patients with IBD in this analysis, there is no specific definition for ‘high-risk activity’ for either homosexual or heterosexual practices, and racial breakdown includes many of unknown race.”

Dr. Ehrlich, who also serves as co-medical director of Temple University Hospital’s inflammatory bowel disease program, is one of the gender-affirming gastroenterologists at the hospital.

“These database studies are often good to generate hypotheses that can be better analyzed with a cohort of patients that you know more about,” Dr. Ehrlich said. “Are patients who identify as LGBTQIA+ more susceptible to IBD? If so, what would the mechanism be? Further study is needed, as they suggest.”

The study was supported by the Clinical Component of the Administrative Core of the NIH Cleveland Digestive Diseases Research Core Center and administrative supplement from the National Institute of Diabetes and Digestive and Kidney Diseases and Sexual and Gender Minority Research Office. The authors and Dr. Ehrlich report no relevant financial relationships.

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

Researchers have developed a scaffold using 3-D bioprinting that slowly releases antibiotics, offering the hope of revolutionizing treatment of diabetic foot ulcers.

Diabetes is among the top 10 causes of deaths worldwide, and in the United Kingdom more than 4.9 million people have diabetes, according to Diabetes UK, who said that “if nothing changes, we predict that 5.5 million people will have diabetes in the UK by 2030.” 

Diabetic foot ulcers affect approximately one in four diabetic patients. Standard therapies, such as pressure offloading and infection management, are often unsuccessful alone and require the introduction of advanced therapies, such as hydrogel wound dressings, which further increases treatment costs and requires hospitalization, highlighted the authors of the study, 3D bioprinted scaffolds for diabetic wound-healing applications.

By the time diabetic foot ulcers are identified, “over 50% are already infected and over 70% of cases result in lower limb amputation,” they said.
 

Drug-loaded scaffold

In their study, published in the journal Drug Delivery and Translational Research, and being presented at the Controlled Release Society Workshop, Italy, this week, researchers from Queen’s University Belfast explained that the treatment strategy required for the effective healing of diabetic foot ulcers is a “complex process” requiring several combined therapeutic approaches. As a result, there is a “significant clinical and economic burden” associated with treating diabetic foot ulcers, they said, and these treatments are often unsuccessful, commonly resulting in lower-limb amputation.

Diabetes UK pointed out that diabetes leads to almost 9,600 leg, toe, or foot amputations every year – “That’s 185 a week,” the charity emphasized. 

Recent research has focused on drug-loaded scaffolds to treat diabetic foot ulcers. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound healing, explained the authors.

Dimitrios Lamprou, PhD, professor of biofabrication and advanced manufacturing, Queen’s School of Pharmacy, and corresponding author, explained: “These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke infection and delay the healing process.”
 

Low-cost treatment alternative

For their proof-of-concept investigation, the researchers made 3-D–bioprinted scaffolds with different designs – honeycomb, square, parallel, triangular, double-parallel – to be used for the sustained release of levofloxacin to the diabetic foot ulcer.

“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound,” explained Dr. Lamprou.

The authors highlighted that square and parallel designs were created to improve flexibility, and that the repeating unit nature of this scaffold would also allow the scaffold to be easily cut to the required size in order to reduce clinical wastage. The triangular and double-parallel designs were created to decrease the available surface area, and the double-parallel design was composed by repeating units to also meet the same clinical benefits.

“This proof of concept study demonstrates the innovative potential of bioprinting technologies in fabrication of antibiotic scaffolds for the treatment of diabetic foot ulcers,” said the authors. The chosen scaffold design provided sustained release of antibiotic over 4 weeks to infected diabetic foot ulcers, demonstrated suitable mechanical properties for tissue engineering purposes, and can be easily modified to the size of the wound, they said.

Katie Glover, PhD, Queen’s School of Pharmacy, lead author, said: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound.”

She added that this provides a “low-cost alternative” to current treatments for diabetic foot ulcers, which could “revolutionize” their treatment. Moreover, it could improve patient outcomes while reducing the economic burden on health services, she said.

A version of this article first appeared on Medscape UK.

Researchers have developed a scaffold using 3-D bioprinting that slowly releases antibiotics, offering the hope of revolutionizing treatment of diabetic foot ulcers.

Diabetes is among the top 10 causes of deaths worldwide, and in the United Kingdom more than 4.9 million people have diabetes, according to Diabetes UK, who said that “if nothing changes, we predict that 5.5 million people will have diabetes in the UK by 2030.” 

Diabetic foot ulcers affect approximately one in four diabetic patients. Standard therapies, such as pressure offloading and infection management, are often unsuccessful alone and require the introduction of advanced therapies, such as hydrogel wound dressings, which further increases treatment costs and requires hospitalization, highlighted the authors of the study, 3D bioprinted scaffolds for diabetic wound-healing applications.

By the time diabetic foot ulcers are identified, “over 50% are already infected and over 70% of cases result in lower limb amputation,” they said.
 

Drug-loaded scaffold

In their study, published in the journal Drug Delivery and Translational Research, and being presented at the Controlled Release Society Workshop, Italy, this week, researchers from Queen’s University Belfast explained that the treatment strategy required for the effective healing of diabetic foot ulcers is a “complex process” requiring several combined therapeutic approaches. As a result, there is a “significant clinical and economic burden” associated with treating diabetic foot ulcers, they said, and these treatments are often unsuccessful, commonly resulting in lower-limb amputation.

Diabetes UK pointed out that diabetes leads to almost 9,600 leg, toe, or foot amputations every year – “That’s 185 a week,” the charity emphasized. 

Recent research has focused on drug-loaded scaffolds to treat diabetic foot ulcers. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound healing, explained the authors.

Dimitrios Lamprou, PhD, professor of biofabrication and advanced manufacturing, Queen’s School of Pharmacy, and corresponding author, explained: “These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke infection and delay the healing process.”
 

Low-cost treatment alternative

For their proof-of-concept investigation, the researchers made 3-D–bioprinted scaffolds with different designs – honeycomb, square, parallel, triangular, double-parallel – to be used for the sustained release of levofloxacin to the diabetic foot ulcer.

“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound,” explained Dr. Lamprou.

The authors highlighted that square and parallel designs were created to improve flexibility, and that the repeating unit nature of this scaffold would also allow the scaffold to be easily cut to the required size in order to reduce clinical wastage. The triangular and double-parallel designs were created to decrease the available surface area, and the double-parallel design was composed by repeating units to also meet the same clinical benefits.

“This proof of concept study demonstrates the innovative potential of bioprinting technologies in fabrication of antibiotic scaffolds for the treatment of diabetic foot ulcers,” said the authors. The chosen scaffold design provided sustained release of antibiotic over 4 weeks to infected diabetic foot ulcers, demonstrated suitable mechanical properties for tissue engineering purposes, and can be easily modified to the size of the wound, they said.

Katie Glover, PhD, Queen’s School of Pharmacy, lead author, said: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound.”

She added that this provides a “low-cost alternative” to current treatments for diabetic foot ulcers, which could “revolutionize” their treatment. Moreover, it could improve patient outcomes while reducing the economic burden on health services, she said.

A version of this article first appeared on Medscape UK.

Researchers have developed a scaffold using 3-D bioprinting that slowly releases antibiotics, offering the hope of revolutionizing treatment of diabetic foot ulcers.

Diabetes is among the top 10 causes of deaths worldwide, and in the United Kingdom more than 4.9 million people have diabetes, according to Diabetes UK, who said that “if nothing changes, we predict that 5.5 million people will have diabetes in the UK by 2030.” 

Diabetic foot ulcers affect approximately one in four diabetic patients. Standard therapies, such as pressure offloading and infection management, are often unsuccessful alone and require the introduction of advanced therapies, such as hydrogel wound dressings, which further increases treatment costs and requires hospitalization, highlighted the authors of the study, 3D bioprinted scaffolds for diabetic wound-healing applications.

By the time diabetic foot ulcers are identified, “over 50% are already infected and over 70% of cases result in lower limb amputation,” they said.
 

Drug-loaded scaffold

In their study, published in the journal Drug Delivery and Translational Research, and being presented at the Controlled Release Society Workshop, Italy, this week, researchers from Queen’s University Belfast explained that the treatment strategy required for the effective healing of diabetic foot ulcers is a “complex process” requiring several combined therapeutic approaches. As a result, there is a “significant clinical and economic burden” associated with treating diabetic foot ulcers, they said, and these treatments are often unsuccessful, commonly resulting in lower-limb amputation.

Diabetes UK pointed out that diabetes leads to almost 9,600 leg, toe, or foot amputations every year – “That’s 185 a week,” the charity emphasized. 

Recent research has focused on drug-loaded scaffolds to treat diabetic foot ulcers. The scaffold structure is a novel carrier for cell and drug delivery that enhances wound healing, explained the authors.

Dimitrios Lamprou, PhD, professor of biofabrication and advanced manufacturing, Queen’s School of Pharmacy, and corresponding author, explained: “These scaffolds are like windows that enable doctors to monitor the healing constantly. This avoids needing to remove them constantly, which can provoke infection and delay the healing process.”
 

Low-cost treatment alternative

For their proof-of-concept investigation, the researchers made 3-D–bioprinted scaffolds with different designs – honeycomb, square, parallel, triangular, double-parallel – to be used for the sustained release of levofloxacin to the diabetic foot ulcer.

“The ‘frame’ has an antibiotic that helps to ‘kill’ the bacteria infection, and the ‘glass’ that can be prepared by collagen/sodium alginate can contain a growth factor to encourage cell growth. The scaffold has two molecular layers that both play an important role in healing the wound,” explained Dr. Lamprou.

The authors highlighted that square and parallel designs were created to improve flexibility, and that the repeating unit nature of this scaffold would also allow the scaffold to be easily cut to the required size in order to reduce clinical wastage. The triangular and double-parallel designs were created to decrease the available surface area, and the double-parallel design was composed by repeating units to also meet the same clinical benefits.

“This proof of concept study demonstrates the innovative potential of bioprinting technologies in fabrication of antibiotic scaffolds for the treatment of diabetic foot ulcers,” said the authors. The chosen scaffold design provided sustained release of antibiotic over 4 weeks to infected diabetic foot ulcers, demonstrated suitable mechanical properties for tissue engineering purposes, and can be easily modified to the size of the wound, they said.

Katie Glover, PhD, Queen’s School of Pharmacy, lead author, said: “Using bioprinting technology, we have developed a scaffold with suitable mechanical properties to treat the wound, which can be easily modified to the size of the wound.”

She added that this provides a “low-cost alternative” to current treatments for diabetic foot ulcers, which could “revolutionize” their treatment. Moreover, it could improve patient outcomes while reducing the economic burden on health services, she said.

A version of this article first appeared on Medscape UK.

A chain of primary care clinics in Minneapolis is likely the first of its kind to be staffed entirely by nurse practitioners (NPs). The Good Clinic offers patients 40-minute exams, as opposed to the 10- to 15-minute appointments typically allotted for physician-staffed clinics, as well as a 1-day wait time instead of 2 weeks.

The chain of six primary care clinics, owned by health care holding company Mitesco, seeks to address the shortage of doctors, particularly among primary care physicians, which results in longer wait times, delayed care, and shorter patient visits.

“As the nation seeks solutions to the challenges of health care access and the rising incidence of chronic disease, it is no surprise that NPs are increasingly the provider of choice for patients,” said April Kapu, DNP, APRN, president of the American Association of Nurse Practitioners.

NPs are in a prime position to address health care disparities and ensure quality and equitable health care access for millions of people in the United States, she said.

According to 2021 data from the U.S. Bureau of Labor Statistics, a 40% increase in the number of NPs is expected over the next 10 years.

Currently, 26 states and Washington, have given full-practice authority (FPA) to NPs, according to the AANP. FPA, as defined by the organization, gives NPs the authority to evaluate, diagnose, and treat patients, as well as order and interpret diagnostic tests under the state board of nursing. This eliminates the need of a collaborative practice agreement between an NP and a physician to provide care.

NPs in Minnesota have FPA, which allows them to see patients and prescribe without doctor oversight.

In a report released last year by the Association of American Medical Colleges, it is projected that there will be a shortage of between 37,800 and 124,000 physicians within 12 years.

Not only is there a dearth of qualified providers, but also there is a significant lack of primary care providers, said Kishlay Anand, MD, founder of Apricus Health in Arizona, which manages health systems. With more physicians choosing to specialize, there are not going to be enough primary care providers, he said. “We have definitely compensated specialty care, but we have not paid adequate compensation for primary prevention,” Dr. Anand told this news organization.

The pandemic has accelerated this shortage by causing physician burnout, said Peter Hahn, MD, CEO of the University of Michigan Health–West. Health care systems, especially in rural areas, are already experiencing this severe shortage, he said. It results in delayed patient care, and as a result, more significant health care needs that trickle down.

It’s what makes primary care, with an emphasis on health promotion and prevention, a great niche for NP-led clinics to address the physician shortage, Dr. Hahn told this news organization. NPs can optimize patient outcomes with fewer resources compared to a physician, he said.
 

Growth of NP field

Improving patient experience and making health care less transactional were priorities for The Good Clinic founder and chief nurse practitioner officer Kevin Lee Smith, DNP.

“The bottom line is we truly wanted to take that nursing perspective where you look at the bio-psycho-social-spiritual being. What is unique [about NPs] is the patient education focus, experience, and holistic care. And NPs are more inclined to take that time because that’s part of our education,” he said.

Nurse practitioner Teal Foster owns Refine Wellness, an independent practice in Stillwater, Minn., which is not affiliated with Mitesco clinics. One reason she started her company was that she was seeing that patients couldn’t get an appointment to see their provider, sometimes for weeks to months. Ms. Foster said she sets her own appointment times, spends more time with patients, and has a greater opportunity to take a more holistic approach to care.

“As nurse practitioners, our education is largely based on prevention and chronic disease management. With that being the focus, it’s seeing the big picture, rather than individual parts of the patient,” Ms. Foster said in an interview.
 

Doctors see need for NPs – with caution

“Nursing education is focused more on health promotion and prevention – tenets that prevent ED costs specifically in underserved populations,” said Dr. Hahn. “In these rural areas or medically underserved communities, NP-led clinics support positive patient experience scores, a sense of security, feelings of trust and respect, and have been shown to help patients gain insights into their own health.”

With the physician shortage, advanced practice providers are a crucial part of the solution for patients, as well as health care systems, Dr. Hahn said. But one challenge to NP-led clinics is the variability in practice regulations from state to state. “Standardization should be considered a high priority to utilize these advanced practice providers effectively and to enable them to consistently practice at the top of their license,” said Dr. Hahn.

The concern of many physicians is that not having physician supervision for early-career NPs can lead to problems, Dr. Anand said. Physicians train much longer than NPs, and it’s what lends to their credibility and their qualification to deliver quality care, he explained. “Patients in rural communities can be very complex and have multiple comorbidities. Sometimes that quick training is not able to do justice to that.”

It’s why Dr. Anand said meeting qualifications and having physician mentorship opportunities would bring a “much-needed safeguard” and regulatory aspects to delivering care in those settings. Even experienced physicians can improve their skills if they have a good coach and mentor, he said.
 

Continuing to collaborate

At The Good Clinic, collaboration operates similarly to at an MD-led clinic, Dr. Smith said. Computer messaging between the six clinics puts NPs in touch with each other instantly.

“Curbside consults” are common. “For example, we’ll have someone who has 20 years of women’s health experience, and the person who has 5 years as an NP might run into a case where they need that person. We’ll do a lot of consulting internally,” explained Dr. Smith.

A partnership with a nearby radiology group lends radiologists who are happy to consult with an NP over the phone about what type of x-ray would be most beneficial, he said. For cases that require a higher level of care, The Good Clinic maintains an extensive referral list.

“We are here to advocate for our patients,” said Dr. Smith. “We have best-practice guidelines in-house, and there’s also that professional accountability and ethics, that you’re not going to go into the territory of managing something that you’re not comfortable with. It takes a village to provide the appropriate care for an individual.”

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

A chain of primary care clinics in Minneapolis is likely the first of its kind to be staffed entirely by nurse practitioners (NPs). The Good Clinic offers patients 40-minute exams, as opposed to the 10- to 15-minute appointments typically allotted for physician-staffed clinics, as well as a 1-day wait time instead of 2 weeks.

The chain of six primary care clinics, owned by health care holding company Mitesco, seeks to address the shortage of doctors, particularly among primary care physicians, which results in longer wait times, delayed care, and shorter patient visits.

“As the nation seeks solutions to the challenges of health care access and the rising incidence of chronic disease, it is no surprise that NPs are increasingly the provider of choice for patients,” said April Kapu, DNP, APRN, president of the American Association of Nurse Practitioners.

NPs are in a prime position to address health care disparities and ensure quality and equitable health care access for millions of people in the United States, she said.

According to 2021 data from the U.S. Bureau of Labor Statistics, a 40% increase in the number of NPs is expected over the next 10 years.

Currently, 26 states and Washington, have given full-practice authority (FPA) to NPs, according to the AANP. FPA, as defined by the organization, gives NPs the authority to evaluate, diagnose, and treat patients, as well as order and interpret diagnostic tests under the state board of nursing. This eliminates the need of a collaborative practice agreement between an NP and a physician to provide care.

NPs in Minnesota have FPA, which allows them to see patients and prescribe without doctor oversight.

In a report released last year by the Association of American Medical Colleges, it is projected that there will be a shortage of between 37,800 and 124,000 physicians within 12 years.

Not only is there a dearth of qualified providers, but also there is a significant lack of primary care providers, said Kishlay Anand, MD, founder of Apricus Health in Arizona, which manages health systems. With more physicians choosing to specialize, there are not going to be enough primary care providers, he said. “We have definitely compensated specialty care, but we have not paid adequate compensation for primary prevention,” Dr. Anand told this news organization.

The pandemic has accelerated this shortage by causing physician burnout, said Peter Hahn, MD, CEO of the University of Michigan Health–West. Health care systems, especially in rural areas, are already experiencing this severe shortage, he said. It results in delayed patient care, and as a result, more significant health care needs that trickle down.

It’s what makes primary care, with an emphasis on health promotion and prevention, a great niche for NP-led clinics to address the physician shortage, Dr. Hahn told this news organization. NPs can optimize patient outcomes with fewer resources compared to a physician, he said.
 

Growth of NP field

Improving patient experience and making health care less transactional were priorities for The Good Clinic founder and chief nurse practitioner officer Kevin Lee Smith, DNP.

“The bottom line is we truly wanted to take that nursing perspective where you look at the bio-psycho-social-spiritual being. What is unique [about NPs] is the patient education focus, experience, and holistic care. And NPs are more inclined to take that time because that’s part of our education,” he said.

Nurse practitioner Teal Foster owns Refine Wellness, an independent practice in Stillwater, Minn., which is not affiliated with Mitesco clinics. One reason she started her company was that she was seeing that patients couldn’t get an appointment to see their provider, sometimes for weeks to months. Ms. Foster said she sets her own appointment times, spends more time with patients, and has a greater opportunity to take a more holistic approach to care.

“As nurse practitioners, our education is largely based on prevention and chronic disease management. With that being the focus, it’s seeing the big picture, rather than individual parts of the patient,” Ms. Foster said in an interview.
 

Doctors see need for NPs – with caution

“Nursing education is focused more on health promotion and prevention – tenets that prevent ED costs specifically in underserved populations,” said Dr. Hahn. “In these rural areas or medically underserved communities, NP-led clinics support positive patient experience scores, a sense of security, feelings of trust and respect, and have been shown to help patients gain insights into their own health.”

With the physician shortage, advanced practice providers are a crucial part of the solution for patients, as well as health care systems, Dr. Hahn said. But one challenge to NP-led clinics is the variability in practice regulations from state to state. “Standardization should be considered a high priority to utilize these advanced practice providers effectively and to enable them to consistently practice at the top of their license,” said Dr. Hahn.

The concern of many physicians is that not having physician supervision for early-career NPs can lead to problems, Dr. Anand said. Physicians train much longer than NPs, and it’s what lends to their credibility and their qualification to deliver quality care, he explained. “Patients in rural communities can be very complex and have multiple comorbidities. Sometimes that quick training is not able to do justice to that.”

It’s why Dr. Anand said meeting qualifications and having physician mentorship opportunities would bring a “much-needed safeguard” and regulatory aspects to delivering care in those settings. Even experienced physicians can improve their skills if they have a good coach and mentor, he said.
 

Continuing to collaborate

At The Good Clinic, collaboration operates similarly to at an MD-led clinic, Dr. Smith said. Computer messaging between the six clinics puts NPs in touch with each other instantly.

“Curbside consults” are common. “For example, we’ll have someone who has 20 years of women’s health experience, and the person who has 5 years as an NP might run into a case where they need that person. We’ll do a lot of consulting internally,” explained Dr. Smith.

A partnership with a nearby radiology group lends radiologists who are happy to consult with an NP over the phone about what type of x-ray would be most beneficial, he said. For cases that require a higher level of care, The Good Clinic maintains an extensive referral list.

“We are here to advocate for our patients,” said Dr. Smith. “We have best-practice guidelines in-house, and there’s also that professional accountability and ethics, that you’re not going to go into the territory of managing something that you’re not comfortable with. It takes a village to provide the appropriate care for an individual.”

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

A chain of primary care clinics in Minneapolis is likely the first of its kind to be staffed entirely by nurse practitioners (NPs). The Good Clinic offers patients 40-minute exams, as opposed to the 10- to 15-minute appointments typically allotted for physician-staffed clinics, as well as a 1-day wait time instead of 2 weeks.

The chain of six primary care clinics, owned by health care holding company Mitesco, seeks to address the shortage of doctors, particularly among primary care physicians, which results in longer wait times, delayed care, and shorter patient visits.

“As the nation seeks solutions to the challenges of health care access and the rising incidence of chronic disease, it is no surprise that NPs are increasingly the provider of choice for patients,” said April Kapu, DNP, APRN, president of the American Association of Nurse Practitioners.

NPs are in a prime position to address health care disparities and ensure quality and equitable health care access for millions of people in the United States, she said.

According to 2021 data from the U.S. Bureau of Labor Statistics, a 40% increase in the number of NPs is expected over the next 10 years.

Currently, 26 states and Washington, have given full-practice authority (FPA) to NPs, according to the AANP. FPA, as defined by the organization, gives NPs the authority to evaluate, diagnose, and treat patients, as well as order and interpret diagnostic tests under the state board of nursing. This eliminates the need of a collaborative practice agreement between an NP and a physician to provide care.

NPs in Minnesota have FPA, which allows them to see patients and prescribe without doctor oversight.

In a report released last year by the Association of American Medical Colleges, it is projected that there will be a shortage of between 37,800 and 124,000 physicians within 12 years.

Not only is there a dearth of qualified providers, but also there is a significant lack of primary care providers, said Kishlay Anand, MD, founder of Apricus Health in Arizona, which manages health systems. With more physicians choosing to specialize, there are not going to be enough primary care providers, he said. “We have definitely compensated specialty care, but we have not paid adequate compensation for primary prevention,” Dr. Anand told this news organization.

The pandemic has accelerated this shortage by causing physician burnout, said Peter Hahn, MD, CEO of the University of Michigan Health–West. Health care systems, especially in rural areas, are already experiencing this severe shortage, he said. It results in delayed patient care, and as a result, more significant health care needs that trickle down.

It’s what makes primary care, with an emphasis on health promotion and prevention, a great niche for NP-led clinics to address the physician shortage, Dr. Hahn told this news organization. NPs can optimize patient outcomes with fewer resources compared to a physician, he said.
 

Growth of NP field

Improving patient experience and making health care less transactional were priorities for The Good Clinic founder and chief nurse practitioner officer Kevin Lee Smith, DNP.

“The bottom line is we truly wanted to take that nursing perspective where you look at the bio-psycho-social-spiritual being. What is unique [about NPs] is the patient education focus, experience, and holistic care. And NPs are more inclined to take that time because that’s part of our education,” he said.

Nurse practitioner Teal Foster owns Refine Wellness, an independent practice in Stillwater, Minn., which is not affiliated with Mitesco clinics. One reason she started her company was that she was seeing that patients couldn’t get an appointment to see their provider, sometimes for weeks to months. Ms. Foster said she sets her own appointment times, spends more time with patients, and has a greater opportunity to take a more holistic approach to care.

“As nurse practitioners, our education is largely based on prevention and chronic disease management. With that being the focus, it’s seeing the big picture, rather than individual parts of the patient,” Ms. Foster said in an interview.
 

Doctors see need for NPs – with caution

“Nursing education is focused more on health promotion and prevention – tenets that prevent ED costs specifically in underserved populations,” said Dr. Hahn. “In these rural areas or medically underserved communities, NP-led clinics support positive patient experience scores, a sense of security, feelings of trust and respect, and have been shown to help patients gain insights into their own health.”

With the physician shortage, advanced practice providers are a crucial part of the solution for patients, as well as health care systems, Dr. Hahn said. But one challenge to NP-led clinics is the variability in practice regulations from state to state. “Standardization should be considered a high priority to utilize these advanced practice providers effectively and to enable them to consistently practice at the top of their license,” said Dr. Hahn.

The concern of many physicians is that not having physician supervision for early-career NPs can lead to problems, Dr. Anand said. Physicians train much longer than NPs, and it’s what lends to their credibility and their qualification to deliver quality care, he explained. “Patients in rural communities can be very complex and have multiple comorbidities. Sometimes that quick training is not able to do justice to that.”

It’s why Dr. Anand said meeting qualifications and having physician mentorship opportunities would bring a “much-needed safeguard” and regulatory aspects to delivering care in those settings. Even experienced physicians can improve their skills if they have a good coach and mentor, he said.
 

Continuing to collaborate

At The Good Clinic, collaboration operates similarly to at an MD-led clinic, Dr. Smith said. Computer messaging between the six clinics puts NPs in touch with each other instantly.

“Curbside consults” are common. “For example, we’ll have someone who has 20 years of women’s health experience, and the person who has 5 years as an NP might run into a case where they need that person. We’ll do a lot of consulting internally,” explained Dr. Smith.

A partnership with a nearby radiology group lends radiologists who are happy to consult with an NP over the phone about what type of x-ray would be most beneficial, he said. For cases that require a higher level of care, The Good Clinic maintains an extensive referral list.

“We are here to advocate for our patients,” said Dr. Smith. “We have best-practice guidelines in-house, and there’s also that professional accountability and ethics, that you’re not going to go into the territory of managing something that you’re not comfortable with. It takes a village to provide the appropriate care for an individual.”

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

Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.

Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.

That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.

Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.

“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.

“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. I fear we will lose these frontline medical professionals unless action is taken to increase accountability and add protections for staff.” Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
 

A paralyzed ED

Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.

While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.

“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.

“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
 

Legislative solutions proposed

Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.

The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”

This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.

A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.

A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
 

Violence’s vicious cycle

“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.

“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”

The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”

Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”

What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.

But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.

In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.

ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.

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

Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.

Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.

That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.

Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.

“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.

“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. I fear we will lose these frontline medical professionals unless action is taken to increase accountability and add protections for staff.” Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
 

A paralyzed ED

Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.

While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.

“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.

“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
 

Legislative solutions proposed

Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.

The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”

This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.

A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.

A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
 

Violence’s vicious cycle

“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.

“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”

The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”

Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”

What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.

But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.

In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.

ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.

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

Acts of violence targeting the professionals who staff America’s emergency departments have gotten significantly worse since the COVID pandemic’s onset – with serious implications for the future provision of emergency medicine. Those are among the conclusions from a new poll conducted for the American College of Emergency Physicians and reported Sept. 22 in a virtual press briefing.

Among 2,712 physicians responding to the ACEP poll conducted from July 25 to Aug. 1, 45% said that violence in the ED has increased greatly and 40% said it has increased somewhat over the past 5 years, while 89% said they believe this violence has harmed patient care. And 55% reported that they personally had been assaulted in the ED – some of them on a weekly or more frequent basis.

That number is up from 49% in a similar poll conducted for ACEP in 2018. One-third (33%) of respondents said they were injured on the job from a workplace assault, up from 27% in 2018. Reported incidents include verbal assaults with the threat of violence as well as being hit, slapped, spit on, punched, kicked, scratched or bit, sexual assaults, and assaults with a weapon like a knife or gun.

Doctors often describe personal encounters that illustrate the survey results. Alex Skog, MD, an emergency physician in Oregon City and president-elect of ACEP’s Oregon state chapter, said that when he was asked to speak at the press briefing, he started reviewing past violent incidents from his own career. But in the weeks leading up to the briefing, two more horrific incidents occurred, highlighting how dire the situation has become for emergency personnel.

“Few memories are more painful to me than an evening about a month ago when an intoxicated patient started roaming down the halls, out of sight of nursing staff due to overcrowding,” Dr. Skog related at the press briefing. “I heard a scream. I was the second person into the room next door. I saw the male patient on the ground straddling a nurse I work with and repeatedly punching her in the head. I wrestled him off and was quickly joined by other staff,” he said.

“I consider the staff I work with not just colleagues but close friends. ... Emergency medicine is hemorrhaging doctors, nurses, and techs who can no longer accept the violence they experience daily. I fear we will lose these frontline medical professionals unless action is taken to increase accountability and add protections for staff.” Violent incidents like these contribute to increased rates of burnout, turnover, and mental health issues for ED professionals.
 

A paralyzed ED

Dr. Skog described another very recent incident where an agitated patient, brought in by ambulance after an intervention involving multiple police and restraints to prevent him from attacking the paramedics transporting him, charged an ED technician, tearing his shirt and wrestling him to the ground.

While the physical trauma that results from events like this is unacceptable, other effects may be less obvious, Dr. Skog said. His department was essentially paralyzed by the turmoil in its ability to care for other emergency patients and had to go on ambulance diversion for several hours, causing delays in the treatment of other critically ill patients.

“The average emergency department clinician is well aware that violence today is completely different than it was 5 years ago, and this survey quantifies that,” Dr. Skog said. Clinicians need to understand how important it is to share their stories and get the word out. ED professionals often fail to report violent incidents because of the belief that nothing will be done about it.

“But without us making it known to everyone, it will be harder to call stakeholders to account to address the problem.” Those stakeholders include hospital administrators, law enforcement, and legislators, Dr. Skog added. “We need to find appropriate venues for holding the people who knowingly assault health care workers accountable.”
 

Legislative solutions proposed

Two bills now in Congress are designed to address the problem of ED violence. While it is late in the legislative season of an election year, ACEP is encouraging legislators to include ED violence as a component of any larger conversation about mental health, patients, and physicians.

The Workplace Violence Prevention Act for Health Care and Social Service Workers, H.R. 1195, which passed the House in 2021 and was introduced in the Senate by Sen. Tammy Baldwin (D-Wisc.), was highlighted in a press conference on the Senate lawn in May, cosponsored by ACEP and the Emergency Nurses Association (ED nurses may have even higher rates of violence on the job). It calls on the Occupational Safety and Health Administration to require employers in health care and social services to establish workplace violence prevention plans in accordance with OSHA’s 2016 “Guidelines for Preventing Workplace Violence for Healthcare and Social Service Workers.”

This bill is supported by the American Public Health Association, although the American Hospital Association opposes it based on increased costs for hospitals. AHA has stated that hospitals already strive to prevent violence in the workplace, although ACEP’s new study reinforces how this is not sufficient.

A recent article in Security suggests that hospitals could start implementing the features of H.R. 1195 even before it becomes law, given its important implications for hospital bottom lines, absenteeism, turnover, and morale.

A second bill, the Safety from Violence for Healthcare Employees Act, H.R. 7961, introduced in June by Rep. Madeleine Dean (D-Pa.) and Rep. Larry Bucshon, MD, (R-Ind.), would create federal penalties for violence against health care workers, similar to protections now in place for airport and airline personnel.
 

Violence’s vicious cycle

“This type of legislation is urgently needed to ensure the safety of all health care providers,” said Robert Glatter, MD, an emergency physician at Lenox Hill Hospital, New York.

“ED violence creates a vicious cycle affecting not only the long-term mental and physical health, but overall well-being and security of health care workers,” Dr. Glatter said in an interview. “It ultimately impacts their ability to perform their jobs in a confident and competent manner. The bottom line is that much more needs to be done to ensure that every member of the team in the ED can make patient care a priority, as opposed to worry and concerns about their own safety.”

The pandemic seriously eroded trust between patients and providers, Dr. Glatter said. This loss of trust is harmful not only to patient care, but to the long-term health and compliance of patients overall. It makes addressing the epidemic of ED violence crucial to all stakeholders, healthcare providers and patients alike.”

Experienced clinicians have a sense of what triggers patients to an act of violence, although that understanding may not help in a fast-moving crisis, Dr. Skog said. In addition to the lack of trust between patients and clinicians, frustrations over delays in treatment, obvious agitation, intoxication, and drug-seeking behavior may be warning signs. “I can see patients’ past violent behavior red-flagged in their chart, but they are still assaulting us.”

What else could help? More use of metal detectors and the 24-hour presence of security personnel able to rapidly respond to escalating situations can be great tools in specific situations, he said. But EDs vary widely in size and setting. Another tool is an emergency device that can alert the entire department in a crisis.

But for Dr. Skog, one of the most important responses is to actually hold patients accountable for their acts of violence – to report them to the police and the criminal justice system. According to the new poll, hospital security departments pressed charges for such incidents a mere 2% of the time.

In Oregon, it now is merely a misdemeanor to assault a hospital worker, he said. A bill proposing to change that just died in the state legislature.

ACEP engaged Marketing General Incorporated to replicate a brief polling survey originally conducted in 2018. Dr. Skog and Dr. Glatter disclosed no relevant financial relationships.

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

Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.

Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.

“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.

“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.

“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.

“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.

For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
 

EVUSHELD was well tolerated

After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.

All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:

• Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
• Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
• Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
• One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.

Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.

“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.

“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.

“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.  
 

Evusheld not always easy to obtain

Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.

Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.

“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.

“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.

Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.

Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.

“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.

“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.

“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”

Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.

 

FDA: Evusheld may not neutralize certain SARS-CoV-2 variants

“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.

In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.

There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.

Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.

Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.

“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.

“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.

“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.

“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.

For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
 

EVUSHELD was well tolerated

After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.

All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:

• Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
• Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
• Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
• One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.

Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.

“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.

“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.

“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.  
 

Evusheld not always easy to obtain

Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.

Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.

“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.

“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.

Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.

Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.

“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.

“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.

“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”

Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.

 

FDA: Evusheld may not neutralize certain SARS-CoV-2 variants

“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.

In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.

There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.

Tixagevimab copackaged with cilgavimab (Evusheld) is a safe and effective preexposure prophylaxis (PrEP) in patients undergoing B-cell-depleting therapies who have poor immune response to COVID-19 vaccination and are at high risk for serious COVID-19 illness, a small, single-site study suggests.

Evusheld, the only COVID-19 PrEP option available, has Emergency Use Authorization (EUA) from the Food and Drug Administration for treatment of immunocompromised patients who may not respond sufficiently to COVID-19 vaccination and patients who’ve had a severe adverse reaction to COVID-19 vaccination.

“We report the largest real-world experience of Evusheld in this population, and our findings are encouraging,” lead study author Cassandra Calabrese, DO, rheumatologist and infectious disease specialist at Cleveland Clinic, said in an interview.

“Of 412 patients who received Evusheld, 12 [2.9%] developed breakthrough COVID-19, with 11 having mild courses and 1 who required hospitalization but recovered,” she added.

“Our data suggest that Evusheld PrEP, in combination with aggressive outpatient treatment of COVID-19, is likely effective in lowering risk of severe COVID in this vulnerable group.

“Practitioners who care for patients with immune-mediated inflammatory diseases should triage high-risk patients for Evusheld as well as rapid diagnosis and aggressive outpatient therapy if infected,” Dr. Calabrese advised.

For the study, Dr. Calabrese and colleagues at Cleveland Clinic searched the health care system pharmacy records for patients with immune‐mediated inflammatory diseases (IMIDs) or inborn errors of humoral immunity (IEI) who met the criteria to receive Evusheld. The researchers included patients on B-cell-depleting therapies or with humoral IEI who had received at least one dose of Evusheld and were later diagnosed with COVID-19, and they excluded those treated with B-cell-depleting therapies for cancer.
 

EVUSHELD was well tolerated

After extracting data on COVID-19 infection, vaccination status, and outcomes, they found that, between Jan. 18 and May 28, 2022, 412 patients with IMIDs or humoral IEI received Evusheld. No deaths occurred among these patients and, overall, they tolerated the medication well.

All 12 patients who experienced breakthrough COVID-19 infection were treated with B-cell-depleting therapies. Among the 12 patients:

• Six patients developed infection 13-84 (median 19) days after receiving 150 mg/150 mg tixagevimab/cilgavimab.
• Six patients developed infection 19-72 (median of 38.5) days after either a single dose of 300 mg/300 mg or a second dose of 150 mg/150 mg.
• Eleven patients had mild illness and recovered at home; one patient was hospitalized and treated with high-flow oxygen. All cases had been vaccinated against COVID-19 (five received two vaccinations, six received three, and one received four).
• One possible serious adverse event involved a patient with COVID-19 and immune-mediated thrombocytopenia (ITP) who was hospitalized soon after receiving Evusheld with ITP flare that resolved with intravenous immunoglobulin.

Dr. Calabrese acknowledged limitations to the study, including few patients, lack of a comparator group, and the study period falling during the Omicron wave.

“Also, nine of the breakthrough cases received additional COVID-19 therapy (oral antiviral or monoclonal antibody), which falls within standard of care for this high-risk group but prevents ascribing effectiveness to individual components of the regimen,” she added.

“Evusheld is authorized for PrEP against COVID-19 in patients at high risk for severe COVID due to suboptimal vaccine responses. This includes patients receiving B-cell-depleting drugs like rituximab, and patients with inborn errors of humoral immunity,” Dr. Calabrese explained.

“It is well known that this group of patients is at very high risk for severe COVID and death, even when fully vaccinated, and it has become clear that more strategies are needed to protect this vulnerable group, including use of Evusheld as well as aggressive treatment if infected,” she added.  
 

Evusheld not always easy to obtain

Although the medication has been available in the United States since January 2022, Dr. Calabrese said, patients may not receive it because of barriers including lack of both awareness and access.

Davey Smith, MD, professor of medicine and head of infectious diseases and global public health at the University of California San Diego, in La Jolla, said in an interview that he was not surprised by the results, but added that the study was conducted in too few patients to draw any strong conclusions or affect patient care.

“This small study that showed that breakthrough infections occurred but were generally mild, provides a small glimpse of real-world use of tixagevimab/cilgavimab as PrEP for immunocompromised persons,” said Dr. Smith, who was not involved in the study.

“In the setting of Omicron and vaccination, I would expect the same outcomes reported even without the treatment,” he added.

Dr. Smith recommends larger related randomized, controlled trials to provide clinicians with sufficient data to guide them in their patient care.

Graham Snyder, MD, associate professor in the division of infectious diseases at the University of Pittsburgh and medical director of infection prevention and hospital epidemiology at the University of Pittsburgh Medical Center, noted that the study “adds to a quickly growing literature on the real-world benefits of tixagevimab/cilgavimab to protect vulnerable individuals with weakened immune systems from the complications of COVID-19.

“This study provides a modest addition to our understanding of the role and benefit of Evusheld,” Dr. Snyder said in an interview. “By characterizing only patients who have received Evusheld without an untreated comparison group, we can’t draw any inference about the extent of benefit the agent provided to these patients.

“Substantial data already show that this agent is effective in preventing complications of COVID-19 infection in immunocompromised individuals,” added Dr. Snyder, who was not involved in the study.

“ ‘Immunocompromised’ represents a very diverse set of clinical conditions,” he said. “The research agenda should therefore focus on a more refined description of the effect in specific populations and a continued understanding of the effect of Evusheld in the context of updated vaccination strategies and changing virus ecology.”

Dr. Calabrese and her colleagues wrote that larger, controlled trials are underway.

 

FDA: Evusheld may not neutralize certain SARS-CoV-2 variants

“The biggest unanswered question is how Evusheld will hold up against new variants,” Dr. Calabrese said.

In an Oct. 3, 2022, update, the Food and Drug Administration released a statement about the risk of developing COVID-19 from SARS-CoV-2 variants that are not neutralized by Evusheld. The statement mentions an updated fact sheet that describes reduced protection from Evusheld against the Omicron subvariant BA.4.6, which accounted for nearly 13% of all new COVID-19 cases in the United States in the week ending Oct. 1.

There was no outside funding for the study. Dr. Smith reported no relevant financial conflicts of interest. Dr. Snyder said he is an unpaid adviser to an AstraZeneca observational study that’s assessing the real-world effectiveness of Evusheld.

Could taking vitamin C help reduce the chances of developing gout? A new study sheds light on this possibility.

Gout is a form of inflammatory arthritis that has been on the rise in the United States in recent decades. Considered a lifestyle disease, some research has shown that instances of the condition have more than doubled in recent years as rates of obesity have skyrocketed. It’s caused by uric acid in the blood that builds up and crystallizes in the joints. Flare-ups are so intense that the joints can turn a cherry red and vibrate with intense – and sometimes seemingly intolerable – pain.

Dmytro Panchenko/iStockphoto

While there are effective treatments, many people fail to take their medications when they’re not in pain, and if the condition goes unchecked, it can get much worse and cause permanent damage to the joints.

“Gout can cause flare-ups that vary in frequency and severity; but sometimes when people aren’t experiencing them, they’re less likely to stay on top of their medications,” said Stephen Juraschek, MD, an assistant professor of medicine at Harvard Medical School, Boston.

That’s why lifestyle interventions are seen as particularly relevant to a disease like gout. Vitamin C, for example, has few side effects, and for those with higher levels of uric acid in the blood, it could reduce the likelihood of getting the condition. A recent study published in The American Journal of Clinical Nutrition found that people who were given 500 mg of vitamin C versus a placebo had a 12% reduced risk of getting gout. The study of over 14,000 male doctors showed that men who weren’t overweight had the most significant reduction in the risk of getting the condition. (Excess weight has been shown to increase the risk of gout.)

As part of the study, participants responded to a questionnaire that asked whether they had ever been diagnosed with gout. Other studies have shown that vitamin C reduced the levels of urate in people without gout and broke down uric crystals in the blood, but this study took it a step further to show that the supplement actually reduced the risk of getting the condition.

“In addition to lowering levels of uric acid in the body, it’s thought that vitamin C may also minimize the inflammatory response to urate crystals,” said Dr. Juraschek. That’s because when flare-ups develop in joints throughout the body, much of the painful irritation is caused by the immune system’s response as it fights to break down the crystals.

Dr. Juraschek said this likely wouldn’t change recommendations for patients with serious gout, but it could still have an impact.

“For individuals who were told that they have gout but have had fewer flare-ups, they might be more open to taking vitamin C,” he said.

Will Settle, 42, of Hilton Head, S.C., was not involved in the study, but he said he would be inclined to try most any safe preventive method. Gout runs in his family. His father and grandfather had it, and now, so does he. His flare-ups have slowed in recent years, which he said has a lot to do with his diet and lifestyle. He stopped eating seafood, started drinking more water, and stopped drinking as much alcohol – all of which he thinks has had a huge impact on the severity of his condition. (Both seafood and beer contain high levels of purines, which have been shown to increase the buildup of uric acid in the blood.) Mr. Settle said that other simple lifestyle changes like vitamin C would be an easy addition to his routine with few downsides. Plus, he hates having to take colchicine, a medication that’s meant to relieve pain but causes him intense diarrhea when he takes it.

“Anything to reduce my flare-ups without having to take colchicine,” he said.

But the jury is still out as to whether vitamin C will have any real benefits. Study coauthor Robert H. Shmerling, MD, is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center, New York. He said the study shows that the effect of vitamin C in those undiagnosed with gout was rather modest. Also, vitamin C did not show a reduction in gout flare-ups in those who were already diagnosed with the condition. Not to mention that the study lacked diversity, as the people in it were all male and mostly white. Still, there’s little downside risk to taking vitamin C, and it might end up being worthwhile.

“Maybe it will turn out to be an effective treatment in those who are at high risk, but we’re not there yet,” he said.

Robert Terkeltaub, MD, chief of rheumatology at the Veterans Administration Medical Center in San Diego and a professor of medicine at the University of California, San Diego, said there’s an unmet need when it comes to tools for gout prevention.

“The disease impacts some 10 million Americans, and we need to better identify these individuals so we can intervene earlier,” he said.

While vitamin C had a small but significant association with fewer new cases of gout, it did not lower it in those who already had the disease, said Dr. Terkeltaub. What’s more, researchers didn’t measure the levels of uric acid in the blood, which would have painted a more accurate picture of whether vitamin C actually reduced it in the body.

“There remains no clarity on the potential role of vitamin C in either prevention or treatment of gout. That said, future research would be of interest,” he said.

Still, gout patients like Mr. Settle aren’t ruling it out. Anything to avoid the pain that, at times, makes it difficult for him to get out of bed. He’s seen the benefit that simple lifestyle changes can make, and he’s willing to try just about anything to live a normal, arthritis-free life.

“I’m always looking for simple ways to keep my flare-ups at bay,” he said.

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

Could taking vitamin C help reduce the chances of developing gout? A new study sheds light on this possibility.

Gout is a form of inflammatory arthritis that has been on the rise in the United States in recent decades. Considered a lifestyle disease, some research has shown that instances of the condition have more than doubled in recent years as rates of obesity have skyrocketed. It’s caused by uric acid in the blood that builds up and crystallizes in the joints. Flare-ups are so intense that the joints can turn a cherry red and vibrate with intense – and sometimes seemingly intolerable – pain.

Dmytro Panchenko/iStockphoto

While there are effective treatments, many people fail to take their medications when they’re not in pain, and if the condition goes unchecked, it can get much worse and cause permanent damage to the joints.

“Gout can cause flare-ups that vary in frequency and severity; but sometimes when people aren’t experiencing them, they’re less likely to stay on top of their medications,” said Stephen Juraschek, MD, an assistant professor of medicine at Harvard Medical School, Boston.

That’s why lifestyle interventions are seen as particularly relevant to a disease like gout. Vitamin C, for example, has few side effects, and for those with higher levels of uric acid in the blood, it could reduce the likelihood of getting the condition. A recent study published in The American Journal of Clinical Nutrition found that people who were given 500 mg of vitamin C versus a placebo had a 12% reduced risk of getting gout. The study of over 14,000 male doctors showed that men who weren’t overweight had the most significant reduction in the risk of getting the condition. (Excess weight has been shown to increase the risk of gout.)

As part of the study, participants responded to a questionnaire that asked whether they had ever been diagnosed with gout. Other studies have shown that vitamin C reduced the levels of urate in people without gout and broke down uric crystals in the blood, but this study took it a step further to show that the supplement actually reduced the risk of getting the condition.

“In addition to lowering levels of uric acid in the body, it’s thought that vitamin C may also minimize the inflammatory response to urate crystals,” said Dr. Juraschek. That’s because when flare-ups develop in joints throughout the body, much of the painful irritation is caused by the immune system’s response as it fights to break down the crystals.

Dr. Juraschek said this likely wouldn’t change recommendations for patients with serious gout, but it could still have an impact.

“For individuals who were told that they have gout but have had fewer flare-ups, they might be more open to taking vitamin C,” he said.

Will Settle, 42, of Hilton Head, S.C., was not involved in the study, but he said he would be inclined to try most any safe preventive method. Gout runs in his family. His father and grandfather had it, and now, so does he. His flare-ups have slowed in recent years, which he said has a lot to do with his diet and lifestyle. He stopped eating seafood, started drinking more water, and stopped drinking as much alcohol – all of which he thinks has had a huge impact on the severity of his condition. (Both seafood and beer contain high levels of purines, which have been shown to increase the buildup of uric acid in the blood.) Mr. Settle said that other simple lifestyle changes like vitamin C would be an easy addition to his routine with few downsides. Plus, he hates having to take colchicine, a medication that’s meant to relieve pain but causes him intense diarrhea when he takes it.

“Anything to reduce my flare-ups without having to take colchicine,” he said.

But the jury is still out as to whether vitamin C will have any real benefits. Study coauthor Robert H. Shmerling, MD, is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center, New York. He said the study shows that the effect of vitamin C in those undiagnosed with gout was rather modest. Also, vitamin C did not show a reduction in gout flare-ups in those who were already diagnosed with the condition. Not to mention that the study lacked diversity, as the people in it were all male and mostly white. Still, there’s little downside risk to taking vitamin C, and it might end up being worthwhile.

“Maybe it will turn out to be an effective treatment in those who are at high risk, but we’re not there yet,” he said.

Robert Terkeltaub, MD, chief of rheumatology at the Veterans Administration Medical Center in San Diego and a professor of medicine at the University of California, San Diego, said there’s an unmet need when it comes to tools for gout prevention.

“The disease impacts some 10 million Americans, and we need to better identify these individuals so we can intervene earlier,” he said.

While vitamin C had a small but significant association with fewer new cases of gout, it did not lower it in those who already had the disease, said Dr. Terkeltaub. What’s more, researchers didn’t measure the levels of uric acid in the blood, which would have painted a more accurate picture of whether vitamin C actually reduced it in the body.

“There remains no clarity on the potential role of vitamin C in either prevention or treatment of gout. That said, future research would be of interest,” he said.

Still, gout patients like Mr. Settle aren’t ruling it out. Anything to avoid the pain that, at times, makes it difficult for him to get out of bed. He’s seen the benefit that simple lifestyle changes can make, and he’s willing to try just about anything to live a normal, arthritis-free life.

“I’m always looking for simple ways to keep my flare-ups at bay,” he said.

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

Could taking vitamin C help reduce the chances of developing gout? A new study sheds light on this possibility.

Gout is a form of inflammatory arthritis that has been on the rise in the United States in recent decades. Considered a lifestyle disease, some research has shown that instances of the condition have more than doubled in recent years as rates of obesity have skyrocketed. It’s caused by uric acid in the blood that builds up and crystallizes in the joints. Flare-ups are so intense that the joints can turn a cherry red and vibrate with intense – and sometimes seemingly intolerable – pain.

Dmytro Panchenko/iStockphoto

While there are effective treatments, many people fail to take their medications when they’re not in pain, and if the condition goes unchecked, it can get much worse and cause permanent damage to the joints.

“Gout can cause flare-ups that vary in frequency and severity; but sometimes when people aren’t experiencing them, they’re less likely to stay on top of their medications,” said Stephen Juraschek, MD, an assistant professor of medicine at Harvard Medical School, Boston.

That’s why lifestyle interventions are seen as particularly relevant to a disease like gout. Vitamin C, for example, has few side effects, and for those with higher levels of uric acid in the blood, it could reduce the likelihood of getting the condition. A recent study published in The American Journal of Clinical Nutrition found that people who were given 500 mg of vitamin C versus a placebo had a 12% reduced risk of getting gout. The study of over 14,000 male doctors showed that men who weren’t overweight had the most significant reduction in the risk of getting the condition. (Excess weight has been shown to increase the risk of gout.)

As part of the study, participants responded to a questionnaire that asked whether they had ever been diagnosed with gout. Other studies have shown that vitamin C reduced the levels of urate in people without gout and broke down uric crystals in the blood, but this study took it a step further to show that the supplement actually reduced the risk of getting the condition.

“In addition to lowering levels of uric acid in the body, it’s thought that vitamin C may also minimize the inflammatory response to urate crystals,” said Dr. Juraschek. That’s because when flare-ups develop in joints throughout the body, much of the painful irritation is caused by the immune system’s response as it fights to break down the crystals.

Dr. Juraschek said this likely wouldn’t change recommendations for patients with serious gout, but it could still have an impact.

“For individuals who were told that they have gout but have had fewer flare-ups, they might be more open to taking vitamin C,” he said.

Will Settle, 42, of Hilton Head, S.C., was not involved in the study, but he said he would be inclined to try most any safe preventive method. Gout runs in his family. His father and grandfather had it, and now, so does he. His flare-ups have slowed in recent years, which he said has a lot to do with his diet and lifestyle. He stopped eating seafood, started drinking more water, and stopped drinking as much alcohol – all of which he thinks has had a huge impact on the severity of his condition. (Both seafood and beer contain high levels of purines, which have been shown to increase the buildup of uric acid in the blood.) Mr. Settle said that other simple lifestyle changes like vitamin C would be an easy addition to his routine with few downsides. Plus, he hates having to take colchicine, a medication that’s meant to relieve pain but causes him intense diarrhea when he takes it.

“Anything to reduce my flare-ups without having to take colchicine,” he said.

But the jury is still out as to whether vitamin C will have any real benefits. Study coauthor Robert H. Shmerling, MD, is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center, New York. He said the study shows that the effect of vitamin C in those undiagnosed with gout was rather modest. Also, vitamin C did not show a reduction in gout flare-ups in those who were already diagnosed with the condition. Not to mention that the study lacked diversity, as the people in it were all male and mostly white. Still, there’s little downside risk to taking vitamin C, and it might end up being worthwhile.

“Maybe it will turn out to be an effective treatment in those who are at high risk, but we’re not there yet,” he said.

Robert Terkeltaub, MD, chief of rheumatology at the Veterans Administration Medical Center in San Diego and a professor of medicine at the University of California, San Diego, said there’s an unmet need when it comes to tools for gout prevention.

“The disease impacts some 10 million Americans, and we need to better identify these individuals so we can intervene earlier,” he said.

While vitamin C had a small but significant association with fewer new cases of gout, it did not lower it in those who already had the disease, said Dr. Terkeltaub. What’s more, researchers didn’t measure the levels of uric acid in the blood, which would have painted a more accurate picture of whether vitamin C actually reduced it in the body.

“There remains no clarity on the potential role of vitamin C in either prevention or treatment of gout. That said, future research would be of interest,” he said.

Still, gout patients like Mr. Settle aren’t ruling it out. Anything to avoid the pain that, at times, makes it difficult for him to get out of bed. He’s seen the benefit that simple lifestyle changes can make, and he’s willing to try just about anything to live a normal, arthritis-free life.

“I’m always looking for simple ways to keep my flare-ups at bay,” he said.

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