A large, multicenter, sham-controlled trial in heart failure showed no benefit at all from stem cell delivery on the primary outcome of recurrent nonfatal decompensated HF events, but the results were still promising, according to the DREAM-HF study’s principal investigator.

When added to guideline-directed medical therapy in patients with HF, a single dose of mesenchymal progenitor cells (MPC) significantly reduced major adverse cardiovascular events (MACE) – a composite of cardiac death, nonfatal MI, and nonfatal stroke – and all-cause death in New York Heart Association (NYHA) class II (but not class III patients), reported Emerson C. Perin, MD, PhD, at the American Heart Association scientific sessions.

The problem is that none of these outcomes were included in the primary endpoint, which was recurrent events because of nonfatal decompensated heart failure. On this endpoint, the hazard ratio for events by the end of follow-up was nonsignificantly but slightly increased among those randomized to MPCs rather than sham control (HR, 1.2; P = .406).

“We learned a lot in this trial,” said Dr. Perin, who is medical director of the Texas Heart Institute in Houston, acknowledging that the expectation of benefit on the primary endpoint now appears to have been misplaced, but the positive result on other outcomes opens a new research direction.

With a negative result on the primary endpoint, a benefit on secondary endpoints is considered hypothesis generating. But Dr. Perin defended his sense of overall optimism about the results, because all of the endpoints on which benefit was demonstrated were prespecified. The positive findings “are not from a post hoc analyses,” he emphasized.
 

DREAM-HF

In the trial, 537 patients with chronic ischemic or nonischemic heart failure with NYHA class II or III symptoms and a left ventricular ejection fraction of 40% or lower were randomized at 51 sites in the United States and Canada. Patients were required to have elevated N-terminal of the prohormone brain natriuretic peptide levels, at least one prior hospitalization for heart failure, and have been on positive inotropic therapy for more than 1 month (but less than 9 months).

The intracardiac administration of MPCs, which are derived from adult human bone marrow, were delivered by injection guided with the NOGA left ventricular electromechanical mapping system. Multiple transendocardial injections were delivered, all in a single session.

There were no differences in baseline characteristics between those receiving MPCs and those who underwent a sham procedure. In both groups, more than half of patients had a previous MI and a coronary revascularization. Nearly 85% had an implanted defibrillator. Roughly two-thirds were in NYHA class III HF and the remaining were in class II.

Over the follow-up, the lines on a graph documenting nonfatal decompensated heart failure events were largely superimposed for the MPC-treated and sham-treated patients, with no significant differences seen over time.

However, the differences on the secondary events were sizable. For the composite outcome of nonfatal MI and nonfatal stroke over a mean follow-up of about 30 months, the rate of events was less than half as great in those randomized to MPCs (4.6% vs. 13.0%). This translated into about 65% reduction in risk (HR, 0.346; P = .001) overall, and the reduction was about the same in class II or III patients.

For a composite endpoint of MACE, events in the group treated with MPCs were about one-third lower than in the sham procedure group (20.3% vs. 30.1%), a difference that also reached significance (HR, 0.667; P = .021).

For this MACE endpoint, response was evaluated by systemic inflammation. For those with a high-sensitivity C-reactive protein (hsCRP) level of less than 2 mg/L, the risk reduction was small and not significant (HR, 0.843; P = .519). Conversely, there was a large risk reduction in those with hsCRP of at least 2 mg/L that did reach statistical significance (HR, 0.551; P = .012).

Inflammation was also found to be a discriminator for time to cardiac death among the patients with NYHA class II HF. Again, there was no benefit among those with hsCRP below 2 mg/L (HR, 1.355; P = .672), but an 80% risk reduction for those with hsCRP of at least 2 mg/L (HR, 0.204; P = .005).

In class II patients with hsCRP at least 2 mg/L, there was also a 60% reduction in all-cause death (HR, 0.401; P = .027). Neither the reduction in cardiac death nor all-cause death was observed in class III HF patients whether or not they had elevated hsCRP.

These signals of benefit provide a direction for a new set of studies, but Dr. Perin said that safety analyses from the DREAM-HF trial are reassuring for further clinical development.

In addition to the fact that “treatment-emergent adverse events and serious adverse events were similar in the MPC-treated and control patients,” Dr. Perin said that MPC administration was not associated with any clinically meaningful immune responses.

MPCs were first injected into a human 15 years ago, according to Dr. Perin. While a phase 2 trial published several years ago did show an association of MPC administration with a reduction in HF-associated events as well as a reduction in adverse ventricular remodeling, the ischemic benefits observed in this trial, particularly in those with elevated hsCRP, provide a new direction for future trials.

“This turns the page in heart failure research. We now have a new mechanism to consider,” Dr. Perin said.
 

Not so fast, expert says

This might be a reasonable conclusion, but the AHA-invited discussant, Larry Allen, MD, believes there is essentially no clinical message from this trial. He reiterated multiple times that this trial was neutral with no trend for benefit on the primary outcome.

“There was benefit on the secondary outcomes of nonfatal MI or stroke, but these are not the outcomes we follow in heart failure patients,” he said, noting that benefit from regenerative therapy on ischemic events has not been a major focus of the trials that preceded DREAM-HF.

Despite these intriguing results, “patients should understand that stem cells remain experimental,” he said. For the patient, it is “more important to double down on the importance of guideline directed medical therapy,” which is still being administered at levels that are suboptimal, according to Dr. Allen, medical director of advanced heart failure at the University of Colorado at Denver, Aurora.

“Keep up the investment” in the promise of stem cell therapy, he said, but he cautioned that some of the secondary benefits observed in DREAM-HF, such as the greater response in patients with elevated hsCRP, appear to be new observations that will require a great deal more study to validate.

Dr. Perin has a financial relationship with Mesoblast, which provided funding for the DREAM-HF trial. Dr. Allen reported no relevant conflicts of interest.

A large, multicenter, sham-controlled trial in heart failure showed no benefit at all from stem cell delivery on the primary outcome of recurrent nonfatal decompensated HF events, but the results were still promising, according to the DREAM-HF study’s principal investigator.

When added to guideline-directed medical therapy in patients with HF, a single dose of mesenchymal progenitor cells (MPC) significantly reduced major adverse cardiovascular events (MACE) – a composite of cardiac death, nonfatal MI, and nonfatal stroke – and all-cause death in New York Heart Association (NYHA) class II (but not class III patients), reported Emerson C. Perin, MD, PhD, at the American Heart Association scientific sessions.

The problem is that none of these outcomes were included in the primary endpoint, which was recurrent events because of nonfatal decompensated heart failure. On this endpoint, the hazard ratio for events by the end of follow-up was nonsignificantly but slightly increased among those randomized to MPCs rather than sham control (HR, 1.2; P = .406).

“We learned a lot in this trial,” said Dr. Perin, who is medical director of the Texas Heart Institute in Houston, acknowledging that the expectation of benefit on the primary endpoint now appears to have been misplaced, but the positive result on other outcomes opens a new research direction.

With a negative result on the primary endpoint, a benefit on secondary endpoints is considered hypothesis generating. But Dr. Perin defended his sense of overall optimism about the results, because all of the endpoints on which benefit was demonstrated were prespecified. The positive findings “are not from a post hoc analyses,” he emphasized.
 

DREAM-HF

In the trial, 537 patients with chronic ischemic or nonischemic heart failure with NYHA class II or III symptoms and a left ventricular ejection fraction of 40% or lower were randomized at 51 sites in the United States and Canada. Patients were required to have elevated N-terminal of the prohormone brain natriuretic peptide levels, at least one prior hospitalization for heart failure, and have been on positive inotropic therapy for more than 1 month (but less than 9 months).

The intracardiac administration of MPCs, which are derived from adult human bone marrow, were delivered by injection guided with the NOGA left ventricular electromechanical mapping system. Multiple transendocardial injections were delivered, all in a single session.

There were no differences in baseline characteristics between those receiving MPCs and those who underwent a sham procedure. In both groups, more than half of patients had a previous MI and a coronary revascularization. Nearly 85% had an implanted defibrillator. Roughly two-thirds were in NYHA class III HF and the remaining were in class II.

Over the follow-up, the lines on a graph documenting nonfatal decompensated heart failure events were largely superimposed for the MPC-treated and sham-treated patients, with no significant differences seen over time.

However, the differences on the secondary events were sizable. For the composite outcome of nonfatal MI and nonfatal stroke over a mean follow-up of about 30 months, the rate of events was less than half as great in those randomized to MPCs (4.6% vs. 13.0%). This translated into about 65% reduction in risk (HR, 0.346; P = .001) overall, and the reduction was about the same in class II or III patients.

For a composite endpoint of MACE, events in the group treated with MPCs were about one-third lower than in the sham procedure group (20.3% vs. 30.1%), a difference that also reached significance (HR, 0.667; P = .021).

For this MACE endpoint, response was evaluated by systemic inflammation. For those with a high-sensitivity C-reactive protein (hsCRP) level of less than 2 mg/L, the risk reduction was small and not significant (HR, 0.843; P = .519). Conversely, there was a large risk reduction in those with hsCRP of at least 2 mg/L that did reach statistical significance (HR, 0.551; P = .012).

Inflammation was also found to be a discriminator for time to cardiac death among the patients with NYHA class II HF. Again, there was no benefit among those with hsCRP below 2 mg/L (HR, 1.355; P = .672), but an 80% risk reduction for those with hsCRP of at least 2 mg/L (HR, 0.204; P = .005).

In class II patients with hsCRP at least 2 mg/L, there was also a 60% reduction in all-cause death (HR, 0.401; P = .027). Neither the reduction in cardiac death nor all-cause death was observed in class III HF patients whether or not they had elevated hsCRP.

These signals of benefit provide a direction for a new set of studies, but Dr. Perin said that safety analyses from the DREAM-HF trial are reassuring for further clinical development.

In addition to the fact that “treatment-emergent adverse events and serious adverse events were similar in the MPC-treated and control patients,” Dr. Perin said that MPC administration was not associated with any clinically meaningful immune responses.

MPCs were first injected into a human 15 years ago, according to Dr. Perin. While a phase 2 trial published several years ago did show an association of MPC administration with a reduction in HF-associated events as well as a reduction in adverse ventricular remodeling, the ischemic benefits observed in this trial, particularly in those with elevated hsCRP, provide a new direction for future trials.

“This turns the page in heart failure research. We now have a new mechanism to consider,” Dr. Perin said.
 

Not so fast, expert says

This might be a reasonable conclusion, but the AHA-invited discussant, Larry Allen, MD, believes there is essentially no clinical message from this trial. He reiterated multiple times that this trial was neutral with no trend for benefit on the primary outcome.

“There was benefit on the secondary outcomes of nonfatal MI or stroke, but these are not the outcomes we follow in heart failure patients,” he said, noting that benefit from regenerative therapy on ischemic events has not been a major focus of the trials that preceded DREAM-HF.

Despite these intriguing results, “patients should understand that stem cells remain experimental,” he said. For the patient, it is “more important to double down on the importance of guideline directed medical therapy,” which is still being administered at levels that are suboptimal, according to Dr. Allen, medical director of advanced heart failure at the University of Colorado at Denver, Aurora.

“Keep up the investment” in the promise of stem cell therapy, he said, but he cautioned that some of the secondary benefits observed in DREAM-HF, such as the greater response in patients with elevated hsCRP, appear to be new observations that will require a great deal more study to validate.

Dr. Perin has a financial relationship with Mesoblast, which provided funding for the DREAM-HF trial. Dr. Allen reported no relevant conflicts of interest.

A large, multicenter, sham-controlled trial in heart failure showed no benefit at all from stem cell delivery on the primary outcome of recurrent nonfatal decompensated HF events, but the results were still promising, according to the DREAM-HF study’s principal investigator.

When added to guideline-directed medical therapy in patients with HF, a single dose of mesenchymal progenitor cells (MPC) significantly reduced major adverse cardiovascular events (MACE) – a composite of cardiac death, nonfatal MI, and nonfatal stroke – and all-cause death in New York Heart Association (NYHA) class II (but not class III patients), reported Emerson C. Perin, MD, PhD, at the American Heart Association scientific sessions.

The problem is that none of these outcomes were included in the primary endpoint, which was recurrent events because of nonfatal decompensated heart failure. On this endpoint, the hazard ratio for events by the end of follow-up was nonsignificantly but slightly increased among those randomized to MPCs rather than sham control (HR, 1.2; P = .406).

“We learned a lot in this trial,” said Dr. Perin, who is medical director of the Texas Heart Institute in Houston, acknowledging that the expectation of benefit on the primary endpoint now appears to have been misplaced, but the positive result on other outcomes opens a new research direction.

With a negative result on the primary endpoint, a benefit on secondary endpoints is considered hypothesis generating. But Dr. Perin defended his sense of overall optimism about the results, because all of the endpoints on which benefit was demonstrated were prespecified. The positive findings “are not from a post hoc analyses,” he emphasized.
 

DREAM-HF

In the trial, 537 patients with chronic ischemic or nonischemic heart failure with NYHA class II or III symptoms and a left ventricular ejection fraction of 40% or lower were randomized at 51 sites in the United States and Canada. Patients were required to have elevated N-terminal of the prohormone brain natriuretic peptide levels, at least one prior hospitalization for heart failure, and have been on positive inotropic therapy for more than 1 month (but less than 9 months).

The intracardiac administration of MPCs, which are derived from adult human bone marrow, were delivered by injection guided with the NOGA left ventricular electromechanical mapping system. Multiple transendocardial injections were delivered, all in a single session.

There were no differences in baseline characteristics between those receiving MPCs and those who underwent a sham procedure. In both groups, more than half of patients had a previous MI and a coronary revascularization. Nearly 85% had an implanted defibrillator. Roughly two-thirds were in NYHA class III HF and the remaining were in class II.

Over the follow-up, the lines on a graph documenting nonfatal decompensated heart failure events were largely superimposed for the MPC-treated and sham-treated patients, with no significant differences seen over time.

However, the differences on the secondary events were sizable. For the composite outcome of nonfatal MI and nonfatal stroke over a mean follow-up of about 30 months, the rate of events was less than half as great in those randomized to MPCs (4.6% vs. 13.0%). This translated into about 65% reduction in risk (HR, 0.346; P = .001) overall, and the reduction was about the same in class II or III patients.

For a composite endpoint of MACE, events in the group treated with MPCs were about one-third lower than in the sham procedure group (20.3% vs. 30.1%), a difference that also reached significance (HR, 0.667; P = .021).

For this MACE endpoint, response was evaluated by systemic inflammation. For those with a high-sensitivity C-reactive protein (hsCRP) level of less than 2 mg/L, the risk reduction was small and not significant (HR, 0.843; P = .519). Conversely, there was a large risk reduction in those with hsCRP of at least 2 mg/L that did reach statistical significance (HR, 0.551; P = .012).

Inflammation was also found to be a discriminator for time to cardiac death among the patients with NYHA class II HF. Again, there was no benefit among those with hsCRP below 2 mg/L (HR, 1.355; P = .672), but an 80% risk reduction for those with hsCRP of at least 2 mg/L (HR, 0.204; P = .005).

In class II patients with hsCRP at least 2 mg/L, there was also a 60% reduction in all-cause death (HR, 0.401; P = .027). Neither the reduction in cardiac death nor all-cause death was observed in class III HF patients whether or not they had elevated hsCRP.

These signals of benefit provide a direction for a new set of studies, but Dr. Perin said that safety analyses from the DREAM-HF trial are reassuring for further clinical development.

In addition to the fact that “treatment-emergent adverse events and serious adverse events were similar in the MPC-treated and control patients,” Dr. Perin said that MPC administration was not associated with any clinically meaningful immune responses.

MPCs were first injected into a human 15 years ago, according to Dr. Perin. While a phase 2 trial published several years ago did show an association of MPC administration with a reduction in HF-associated events as well as a reduction in adverse ventricular remodeling, the ischemic benefits observed in this trial, particularly in those with elevated hsCRP, provide a new direction for future trials.

“This turns the page in heart failure research. We now have a new mechanism to consider,” Dr. Perin said.
 

Not so fast, expert says

This might be a reasonable conclusion, but the AHA-invited discussant, Larry Allen, MD, believes there is essentially no clinical message from this trial. He reiterated multiple times that this trial was neutral with no trend for benefit on the primary outcome.

“There was benefit on the secondary outcomes of nonfatal MI or stroke, but these are not the outcomes we follow in heart failure patients,” he said, noting that benefit from regenerative therapy on ischemic events has not been a major focus of the trials that preceded DREAM-HF.

Despite these intriguing results, “patients should understand that stem cells remain experimental,” he said. For the patient, it is “more important to double down on the importance of guideline directed medical therapy,” which is still being administered at levels that are suboptimal, according to Dr. Allen, medical director of advanced heart failure at the University of Colorado at Denver, Aurora.

“Keep up the investment” in the promise of stem cell therapy, he said, but he cautioned that some of the secondary benefits observed in DREAM-HF, such as the greater response in patients with elevated hsCRP, appear to be new observations that will require a great deal more study to validate.

Dr. Perin has a financial relationship with Mesoblast, which provided funding for the DREAM-HF trial. Dr. Allen reported no relevant conflicts of interest.

Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.¹ It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.¹ Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).^2,3

In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.

In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:

1. cervical dilation
2. introduction of the Sonata system
3. sonographic identification of the target fibroid
4. adjust size and shape of Smart Guide overlays
5. deploy the introducer
6. safety rotation check
7. deploy the needle electrodes
8. initiate RFA
9. withdraw needle electrodes and introducer.

RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.

We hope that you find this video useful to your clinical practice.

>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES

Vidyard Video

Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.¹ It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.¹ Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).^2,3

In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.

In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:

1. cervical dilation
2. introduction of the Sonata system
3. sonographic identification of the target fibroid
4. adjust size and shape of Smart Guide overlays
5. deploy the introducer
6. safety rotation check
7. deploy the needle electrodes
8. initiate RFA
9. withdraw needle electrodes and introducer.

RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.

We hope that you find this video useful to your clinical practice.

>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES

Vidyard Video

Uterine leiomyomas affect 70% to 80% of reproductive-age women. Interventions for symptomatic patients include myomectomy, hysterectomy, uterine artery embolization (UAE), and radiofrequency ablation (RFA). Several RFA devices exist on the market. One such device is the sonography-guided transcervical ablation of uterine fibroids (Sonata), which is unique in its transcervical approach that allows for incisionless treatment.¹ It can be used to treat fibroids classified as FIGO 1-6 with a radius up to 5 cm.¹ Postablative therapy outcomes at 1 and 2 years have been promising for total volume reduction (mean maximal volume reduction, 63.8%) and improvement in symptoms, including quality-of-life measures and amount of bleeding (95% reported reduction).^2,3

In our practice, we find this tool most helpful for medium-sized (3–5 cm) intramural fibroids and large type 2 fibroids.

In the accompanying video, we illustrate the steps for use of transcervical ultrasonographic RFA with Sonata treatment and demonstrate its impact on the uterus during simultaneous laparoscopy. We present a patient who underwent Sonata treatment for a 4-cm intramural fibroid and simultaneous laparoscopic myomectomy for a 4-cm pedunculated fibroid. This allowed for the unique ability to view the external effect on the uterus during Sonata use. We review the key surgical steps with this approach, including:

1. cervical dilation
2. introduction of the Sonata system
3. sonographic identification of the target fibroid
4. adjust size and shape of Smart Guide overlays
5. deploy the introducer
6. safety rotation check
7. deploy the needle electrodes
8. initiate RFA
9. withdraw needle electrodes and introducer.

RFA with Sonata treatment is a simple, minimally invasive therapeutic option for fibroids.

We hope that you find this video useful to your clinical practice.

>>DR. ARNOLD P. ADVINCULA AND COLLEAGUES

Vidyard Video

LAS VEGAS – Clinical trials of treatments for inflammatory bowel disease (IBD) have disproportionately enrolled White people, researchers say.

FatCamera/Getty Images

These skewed demographics could result in researchers overlooking differences in how the disease and its treatments might affect other racial and ethnic groups, said Jellyana Peraza, MD, a chief resident at Albert Einstein College of Medicine, New York.

“The only way we can determine that therapies work differently in different populations is by including those populations in these clinical trials,” she said in an interview. “We think that diversity should be present, and that will answer some questions about the pathogenesis of the disease in general.”

Dr. Peraza presented the findings at the annual meeting of the American College of Gastroenterology.

Previous studies have found that, in trials of other conditions, such as cancer and cardiovascular disease, White people have been disproportionately represented. However, little research has been conducted regarding race and ethnicity in IBD trials.

To fill that gap, Dr. Peraza and colleagues analyzed data from completed trials through the U.S. National Library of Medicine’s registry, ClinicalTrials.gov, for the period from 2000 to 2020.

They found 22 trials conducted exclusively in the United States and 56 conducted in other countries that reported the race or ethnicity of participants; 54 trials did not include this information.

With regard to the prevalence of IBD in White people and Asian people, these populations were overrepresented in U.S. clinical trials. All other groups were underrepresented.

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

LAS VEGAS – Clinical trials of treatments for inflammatory bowel disease (IBD) have disproportionately enrolled White people, researchers say.

FatCamera/Getty Images

These skewed demographics could result in researchers overlooking differences in how the disease and its treatments might affect other racial and ethnic groups, said Jellyana Peraza, MD, a chief resident at Albert Einstein College of Medicine, New York.

“The only way we can determine that therapies work differently in different populations is by including those populations in these clinical trials,” she said in an interview. “We think that diversity should be present, and that will answer some questions about the pathogenesis of the disease in general.”

Dr. Peraza presented the findings at the annual meeting of the American College of Gastroenterology.

Previous studies have found that, in trials of other conditions, such as cancer and cardiovascular disease, White people have been disproportionately represented. However, little research has been conducted regarding race and ethnicity in IBD trials.

To fill that gap, Dr. Peraza and colleagues analyzed data from completed trials through the U.S. National Library of Medicine’s registry, ClinicalTrials.gov, for the period from 2000 to 2020.

They found 22 trials conducted exclusively in the United States and 56 conducted in other countries that reported the race or ethnicity of participants; 54 trials did not include this information.

With regard to the prevalence of IBD in White people and Asian people, these populations were overrepresented in U.S. clinical trials. All other groups were underrepresented.

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

LAS VEGAS – Clinical trials of treatments for inflammatory bowel disease (IBD) have disproportionately enrolled White people, researchers say.

FatCamera/Getty Images

These skewed demographics could result in researchers overlooking differences in how the disease and its treatments might affect other racial and ethnic groups, said Jellyana Peraza, MD, a chief resident at Albert Einstein College of Medicine, New York.

“The only way we can determine that therapies work differently in different populations is by including those populations in these clinical trials,” she said in an interview. “We think that diversity should be present, and that will answer some questions about the pathogenesis of the disease in general.”

Dr. Peraza presented the findings at the annual meeting of the American College of Gastroenterology.

Previous studies have found that, in trials of other conditions, such as cancer and cardiovascular disease, White people have been disproportionately represented. However, little research has been conducted regarding race and ethnicity in IBD trials.

To fill that gap, Dr. Peraza and colleagues analyzed data from completed trials through the U.S. National Library of Medicine’s registry, ClinicalTrials.gov, for the period from 2000 to 2020.

They found 22 trials conducted exclusively in the United States and 56 conducted in other countries that reported the race or ethnicity of participants; 54 trials did not include this information.

With regard to the prevalence of IBD in White people and Asian people, these populations were overrepresented in U.S. clinical trials. All other groups were underrepresented.

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

ANSWER

The correct answer is inclusion cyst (choice “c”).

DISCUSSION

Inclusion cysts are also called traumatic inclusion cysts or implantation cysts and are quite distinct from “sebaceous,” epidermal, or epidermoid cysts. An inclusion cyst results from traumatic implantation of surface adnexal structures (eg, sebaceous glands) that continue to function, eventuating in the formation of an organized sac whose wall is composed of stratified squamous epithelium with a granular layer, no significant atypia, and surrounding pasty lamellated acellular keratin.

Hands are the most commonly affected area, although the precipitating puncture wound doesn’t have to be as impressive as this patient’s was. Nails and sewing needles can produce the same result.

The patient’s lesion was removed, at which point its pasty contents (a diagnostic clue) were revealed, and the wound closed. Although the absence of redness or tenderness helped to rule out some items in the differential (eg, felon, abscess), and the lesion demonstrated clear cystic features, the specimen was sent for pathologic examination for confirmation, since cancer would also belong in the differential for such a lesion.

ANSWER

The correct answer is inclusion cyst (choice “c”).

DISCUSSION

Inclusion cysts are also called traumatic inclusion cysts or implantation cysts and are quite distinct from “sebaceous,” epidermal, or epidermoid cysts. An inclusion cyst results from traumatic implantation of surface adnexal structures (eg, sebaceous glands) that continue to function, eventuating in the formation of an organized sac whose wall is composed of stratified squamous epithelium with a granular layer, no significant atypia, and surrounding pasty lamellated acellular keratin.

Hands are the most commonly affected area, although the precipitating puncture wound doesn’t have to be as impressive as this patient’s was. Nails and sewing needles can produce the same result.

The patient’s lesion was removed, at which point its pasty contents (a diagnostic clue) were revealed, and the wound closed. Although the absence of redness or tenderness helped to rule out some items in the differential (eg, felon, abscess), and the lesion demonstrated clear cystic features, the specimen was sent for pathologic examination for confirmation, since cancer would also belong in the differential for such a lesion.

ANSWER

The correct answer is inclusion cyst (choice “c”).

DISCUSSION

Inclusion cysts are also called traumatic inclusion cysts or implantation cysts and are quite distinct from “sebaceous,” epidermal, or epidermoid cysts. An inclusion cyst results from traumatic implantation of surface adnexal structures (eg, sebaceous glands) that continue to function, eventuating in the formation of an organized sac whose wall is composed of stratified squamous epithelium with a granular layer, no significant atypia, and surrounding pasty lamellated acellular keratin.

Hands are the most commonly affected area, although the precipitating puncture wound doesn’t have to be as impressive as this patient’s was. Nails and sewing needles can produce the same result.

The patient’s lesion was removed, at which point its pasty contents (a diagnostic clue) were revealed, and the wound closed. Although the absence of redness or tenderness helped to rule out some items in the differential (eg, felon, abscess), and the lesion demonstrated clear cystic features, the specimen was sent for pathologic examination for confirmation, since cancer would also belong in the differential for such a lesion.

Among active-duty men who have sex with men (MSM), Black and Latino military members are at least three times as likely to be prescribed HIV pre-exposure prophylaxis (PrEP) than their White counterparts, according to new survey results.

“In the civilian population, we see a lot of challenges and barriers to [accessing PrEP] in our high-risk populations – populations in the MSM sphere that are people of color,” study author Colten Staten, RN, a first lieutenant in the army at Walter Reed National Military Medical Center in Bethesda, Md., told this news organization. Because all active-duty service members have free medical care and prescriptions through the Military Health System, the findings demonstrate “what happens when access becomes less of an issue in regard to receiving PrEP prescriptions,” he noted.

The survey, which was presented at the Association of Nurses in AIDS Care 2021 conference, was available for 5 days in 2020. All participants were at least 18 years old, identified as MSM, and were active-duty members of the United States military.

Of the 354 men included in the study, 37.6% were White, 25.4% were Black, 20.3% were identified as Latino, 6.5% were Asian/Pacific Islanders, and 5.6% were Native Americans. In addition, 69.5% identified as gay, 23.4% identified as bisexual, and 7% said they were straight. And 17.2% had a partner who disclosed he was HIV positive, but 19.2% did not know the status of their partner.

Black participants were three times more likely to have been prescribed PrEP than White service members (P < .001). Similarly, Latino respondents were 3.6 times more likely to be prescribed PrEP than their White counterparts (P = .003). Participants whose partner disclosed an HIV-positive status were 7.1 times more likely to receive a PrEP prescription than someone who did not know the status of their partner (P = .013), and bisexual respondents were 2.1 times less likely to have received a PrEP prescription than respondents who identified as gay (P = .04).

While the study demonstrates that at-risk populations are receiving PrEP in the military, research suggests that PrEP is still underprescribed in this population, Mr. Staten said. A 2018 study published in Morbidity and Mortality Weekly Report found that 20.9% of U.S. service members reported a high risk of HIV infection, and an estimated 12,000 individuals in the military qualify for a PrEP prescription. Yet, from Feb. 1, 2014, to June 10, 2016, only 759 service members were prescribed Truvada. The 2018 report found that approximately 350 active-duty service members are diagnosed with HIV every year, with a disproportionate number of new infections occurring in Black individuals.

While the study suggests prescriptions are reaching target populations, “the most concerning finding is that it is not happening in the robust nature that we need,” said Justin Alves, RN, ACRN, CARN, a nurse at Boston Medical Center in Massachusetts who was not involved with the study, in an interview. “This is the start of a lot of research that needs to happen, because not only does the study shed light on people who are serving in the military, but it also sheds light on unique vulnerable populations that we have a hard time capturing and helping in general healthcare settings,” Mr. Alves said.

Mr. Staten agreed that more research is needed to identify additional barriers to care in the military. Additionally, including more information on sexual history in the yearly physical all active-duty service members complete could also help identify more individuals who would benefit from a PrEP prescription.  

“There is no screening for sexual health, as far as the MSM experience,” Mr. Staten said. And he suggested that more questions around sexuality should be included in the screening process. That could help spur more open conversations between patients and providers to bridge gaps in access and care.

Mr. Staten is an active-duty service member. Mr. Alves has reported no relevant financial relationships.

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

Among active-duty men who have sex with men (MSM), Black and Latino military members are at least three times as likely to be prescribed HIV pre-exposure prophylaxis (PrEP) than their White counterparts, according to new survey results.

“In the civilian population, we see a lot of challenges and barriers to [accessing PrEP] in our high-risk populations – populations in the MSM sphere that are people of color,” study author Colten Staten, RN, a first lieutenant in the army at Walter Reed National Military Medical Center in Bethesda, Md., told this news organization. Because all active-duty service members have free medical care and prescriptions through the Military Health System, the findings demonstrate “what happens when access becomes less of an issue in regard to receiving PrEP prescriptions,” he noted.

The survey, which was presented at the Association of Nurses in AIDS Care 2021 conference, was available for 5 days in 2020. All participants were at least 18 years old, identified as MSM, and were active-duty members of the United States military.

Of the 354 men included in the study, 37.6% were White, 25.4% were Black, 20.3% were identified as Latino, 6.5% were Asian/Pacific Islanders, and 5.6% were Native Americans. In addition, 69.5% identified as gay, 23.4% identified as bisexual, and 7% said they were straight. And 17.2% had a partner who disclosed he was HIV positive, but 19.2% did not know the status of their partner.

Black participants were three times more likely to have been prescribed PrEP than White service members (P < .001). Similarly, Latino respondents were 3.6 times more likely to be prescribed PrEP than their White counterparts (P = .003). Participants whose partner disclosed an HIV-positive status were 7.1 times more likely to receive a PrEP prescription than someone who did not know the status of their partner (P = .013), and bisexual respondents were 2.1 times less likely to have received a PrEP prescription than respondents who identified as gay (P = .04).

While the study demonstrates that at-risk populations are receiving PrEP in the military, research suggests that PrEP is still underprescribed in this population, Mr. Staten said. A 2018 study published in Morbidity and Mortality Weekly Report found that 20.9% of U.S. service members reported a high risk of HIV infection, and an estimated 12,000 individuals in the military qualify for a PrEP prescription. Yet, from Feb. 1, 2014, to June 10, 2016, only 759 service members were prescribed Truvada. The 2018 report found that approximately 350 active-duty service members are diagnosed with HIV every year, with a disproportionate number of new infections occurring in Black individuals.

While the study suggests prescriptions are reaching target populations, “the most concerning finding is that it is not happening in the robust nature that we need,” said Justin Alves, RN, ACRN, CARN, a nurse at Boston Medical Center in Massachusetts who was not involved with the study, in an interview. “This is the start of a lot of research that needs to happen, because not only does the study shed light on people who are serving in the military, but it also sheds light on unique vulnerable populations that we have a hard time capturing and helping in general healthcare settings,” Mr. Alves said.

Mr. Staten agreed that more research is needed to identify additional barriers to care in the military. Additionally, including more information on sexual history in the yearly physical all active-duty service members complete could also help identify more individuals who would benefit from a PrEP prescription.  

“There is no screening for sexual health, as far as the MSM experience,” Mr. Staten said. And he suggested that more questions around sexuality should be included in the screening process. That could help spur more open conversations between patients and providers to bridge gaps in access and care.

Mr. Staten is an active-duty service member. Mr. Alves has reported no relevant financial relationships.

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

Among active-duty men who have sex with men (MSM), Black and Latino military members are at least three times as likely to be prescribed HIV pre-exposure prophylaxis (PrEP) than their White counterparts, according to new survey results.

“In the civilian population, we see a lot of challenges and barriers to [accessing PrEP] in our high-risk populations – populations in the MSM sphere that are people of color,” study author Colten Staten, RN, a first lieutenant in the army at Walter Reed National Military Medical Center in Bethesda, Md., told this news organization. Because all active-duty service members have free medical care and prescriptions through the Military Health System, the findings demonstrate “what happens when access becomes less of an issue in regard to receiving PrEP prescriptions,” he noted.

The survey, which was presented at the Association of Nurses in AIDS Care 2021 conference, was available for 5 days in 2020. All participants were at least 18 years old, identified as MSM, and were active-duty members of the United States military.

Of the 354 men included in the study, 37.6% were White, 25.4% were Black, 20.3% were identified as Latino, 6.5% were Asian/Pacific Islanders, and 5.6% were Native Americans. In addition, 69.5% identified as gay, 23.4% identified as bisexual, and 7% said they were straight. And 17.2% had a partner who disclosed he was HIV positive, but 19.2% did not know the status of their partner.

Black participants were three times more likely to have been prescribed PrEP than White service members (P < .001). Similarly, Latino respondents were 3.6 times more likely to be prescribed PrEP than their White counterparts (P = .003). Participants whose partner disclosed an HIV-positive status were 7.1 times more likely to receive a PrEP prescription than someone who did not know the status of their partner (P = .013), and bisexual respondents were 2.1 times less likely to have received a PrEP prescription than respondents who identified as gay (P = .04).

While the study demonstrates that at-risk populations are receiving PrEP in the military, research suggests that PrEP is still underprescribed in this population, Mr. Staten said. A 2018 study published in Morbidity and Mortality Weekly Report found that 20.9% of U.S. service members reported a high risk of HIV infection, and an estimated 12,000 individuals in the military qualify for a PrEP prescription. Yet, from Feb. 1, 2014, to June 10, 2016, only 759 service members were prescribed Truvada. The 2018 report found that approximately 350 active-duty service members are diagnosed with HIV every year, with a disproportionate number of new infections occurring in Black individuals.

While the study suggests prescriptions are reaching target populations, “the most concerning finding is that it is not happening in the robust nature that we need,” said Justin Alves, RN, ACRN, CARN, a nurse at Boston Medical Center in Massachusetts who was not involved with the study, in an interview. “This is the start of a lot of research that needs to happen, because not only does the study shed light on people who are serving in the military, but it also sheds light on unique vulnerable populations that we have a hard time capturing and helping in general healthcare settings,” Mr. Alves said.

Mr. Staten agreed that more research is needed to identify additional barriers to care in the military. Additionally, including more information on sexual history in the yearly physical all active-duty service members complete could also help identify more individuals who would benefit from a PrEP prescription.  

“There is no screening for sexual health, as far as the MSM experience,” Mr. Staten said. And he suggested that more questions around sexuality should be included in the screening process. That could help spur more open conversations between patients and providers to bridge gaps in access and care.

Mr. Staten is an active-duty service member. Mr. Alves has reported no relevant financial relationships.

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

Insufficient HIV-related nursing education is a major barrier to implementing HIV screening efforts in emergency departments (EDs), according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.

This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.

In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.

In the 30- to 45-minute survey, respondents reported:

• Demographic information
• Knowledge of the CDC HIV screening recommendations
• Workplace HIV screening policy
• Self-reported performance of HIV screening
• Beliefs and attitudes pertaining to HIV screening

Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.

“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.

Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.

“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.

Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”

Elam and Leimer have reported no relevant financial relationships.

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

Insufficient HIV-related nursing education is a major barrier to implementing HIV screening efforts in emergency departments (EDs), according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.

This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.

In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.

In the 30- to 45-minute survey, respondents reported:

• Demographic information
• Knowledge of the CDC HIV screening recommendations
• Workplace HIV screening policy
• Self-reported performance of HIV screening
• Beliefs and attitudes pertaining to HIV screening

Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.

“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.

Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.

“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.

Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”

Elam and Leimer have reported no relevant financial relationships.

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

Insufficient HIV-related nursing education is a major barrier to implementing HIV screening efforts in emergency departments (EDs), according to a national survey of ED nurses. Nearly 43% of respondents said they had received “little” or “very little” HIV education as part of their professional development and practice.

This lack of continuing HIV education “often translated into attitudes that did not support the policy” of routine HIV screening in EDs, lead author Candace Elam, DNP, a family nurse practitioner at the Institute of Family Health in the Bronx, New York City, told this news organization. “But more than individual attitudes, what came out most clearly in the research was that organizational support for HIV screening in EDs was the one factor that could make or break whether an emergency nurse performs HIV screening,” she said. This includes working routine HIV screening into ED workflows and providing resources to streamline screening and testing efforts.

In 2006, the Centers for Disease Control and Prevention released guidance recommending routine HIV screening in all healthcare settings, including urgent care and EDs. Elam, who conducted the research as a student at Rutgers University School of Nursing in New Brunswick, N.J., noticed during her time as an ED nurse that, while her department had a policy supporting routine HIV screening, the practice was not consistent across all nursing staff. To find out how HIV screening varied nationally, Elam ran a national survey from Oct. through Dec. 2020, recruiting participants both by email outreach and Facebook.

In the 30- to 45-minute survey, respondents reported:

• Demographic information
• Knowledge of the CDC HIV screening recommendations
• Workplace HIV screening policy
• Self-reported performance of HIV screening
• Beliefs and attitudes pertaining to HIV screening

Overall, 371 individuals from 43 states filled out at least some part of the survey, and 171 individuals completed it. Of the 251 individuals who answered whether their EDs routinely conducted HIV screening, 76.9% responded affirmatively. Overall, 28.5% of respondents thought HIV screening was “not important” or “not at all important.” Nearly half – 47.6% – reported never offering HIV testing to all eligible patients regardless of risk factors, and only 14.3% reported offering testing all of the time. Only 25% of participants said they received “adequate” or “a lot” of HIV-related nursing education, and 42.9% reported “little” or “very little” education.

“For the most part, those of us working in hospitals, all the education that we get about HIV took place in school,” Elam said. “So, if you went to school in the early 2000s or in the 1990s, you don’t know much else.” Elam noted that she keeps informed on HIV research issues because it is an area of interest, but the hospital she had worked at did not contribute much to her knowledge.

Elam also found that in practice there were several barriers to performing screening, such as lack of availability of a dedicated HIV educator, tester, or counselors; not knowing where to refer patients who had a positive HIV test result; and insufficient time to address positive HIV test results in ED practice.

“A lot of these things are outside an individual nurse’s control,” said Elam, and can result in missing patients who would benefit from care. Lisa Leimer, RN, a nurse at Primary Health Care in Des Moines, works with patients after they have been diagnosed with HIV, but noted that many of her patients could have been identified earlier. “Once we get someone, you look back at medical records and you see that they have been in and out of the hospital,” she said. “There’s been multiple encounters,” she said.

Prioritizing HIV screening in all healthcare settings and including HIV education for all medical professionals – not just nurses – could help in the continuing battle against HIV. “So much has changed in the world of HIV,” she said. “We’re trying to end the epidemic, and it could happen if we identified, diagnosed, and treated the people that are living with it.”

Elam and Leimer have reported no relevant financial relationships.

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

Cheryl K. Lee, MD, an Assistant Professor of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency. 
 

Is it fair to say that for hospitalists, the pandemic has been a sobering experience, why so?

Dr. Lee: There are several reasons; one stems from the increasing impact of Covid on children. Early in the pandemic, young children, teens, and young adults were not infected or hospitalized at the rate of older adults.¹ For those of us who care for hospitalized patients, that early finding was somewhat of a relief, knowing at least one portion of the population wasn’t as heavily affected. In fact, I normally split my time as a pediatric and adult hospitalist, and I was reassigned to work full-time in the adult hospital because so few children had been admitted. But all that changed with the arrival of the highly transmissible Delta variant and the loosening of social distancing and masking guidelines and other regulations. The American Academy of Pediatrics² reported that, as of October, 8,364 of every 100,000 children have been infected by Covid, largely driven by  the summer surge. Furthermore, pediatric Covid hospitalizations increased five-fold in August 2021 as compared to the prior 6 weeks. And these numbers likely underestimate the true impact, as several states did not release complete reports and did not account for long-term sequelae from milder infections.

What other issues were far-reaching for hospitalists?

Dr. Lee: Early in 2020, we were scrambling to learn about a novel, deadly, highly transmissible disease. Some groups in our population were experiencing a high fatality rate, and the medical community had no proven treatments. We felt helpless in caring for these patients who pleaded for our help and ultimately died. When data proved that medications like steroids were effective and the vaccines arrived, I had hoped that the pandemic would be ending. But now with the quick dissemination of false information and the evolution of new variants, we are left caring for seriously ill, unvaccinated patients along with younger patients. The heartbreaking thing is that these are largely preventable tragedies now that we have effective vaccines.

What medications have changed the course of Covid in the hospital?

Dr. Lee: Steroids are interesting; they are a good reminder that Covid has different stages and that we should be mindful of how we treat patients within those particular stages. Simply, Covid infection begins with a phase of viral replication characterized by fevers, cough, loss of taste and smell, and gastrointestinal symptoms. In time, this is followed by a second phase of high inflammation and immune response, sometimes causing hypoxemia and respiratory failure. What we know is that steroids such as dexamethasone reduce mortality, but they are only effective during this second phase, and only in those whose oxygen levels are low enough to require oxygen. This was not an intuitive finding, since steroids do not help, and may harm, those with other viral pneumonias, such as influenza. Steroid use in severe, hypoxemic Covid, however, is life-saving and the mainstay of inpatient care which might include antivirals and interleukin-6 inhibitors³ in select patients. As with steroid use in other patients, physicians should watch their Covid patients for hyperglycemia⁴ and delirium. That said, steroids provide a  mortality benefit that strongly supports their continued use -- in tandem with management of those expected side effects. Last, it is important to note that steroid use has been associated with possible harm when given to those with mild Covid,⁵ so its use should be avoided, in light of its expected side effects, unless a patient requires supplemental oxygen.

That said, although steroids can be helpful for our sickest patients, vaccines are the best medicine of all because they can allow patients to avoid hospitalization and death  -- outcomes that far outweigh what steroids or any other medication can do for the gravely ill.

Given the complexity of the evidence surrounding the treatments for Covid in the hospital, no wonder some people are confused about which medicines work.

Dr. Lee: First, let me say that I have yet to encounter a patient or family member whose motivation to ask questions or question a loved one’s treatment wasn’t grounded in concern and fear for their loved one.

What do they ask about?

Dr. Lee: They ask about alternative treatments, anti-parasitics, even vitamins. I agree with them that there is so much out there about Covid that it is difficult for anyone to know what is true or false. I then explain what therapies are proven – medications such as steroids and supportive care such as oxygen and prone positioning. I also review the lack of good evidence for the alternative treatments that they ask about. It is sometimes surprising to folks that all research isn’t conducted with equal rigor, and that false conclusions can be made based on faulty evidence. A good example is how providers used hydroxychloroquine early in the pandemic, but ultimately it didn’t prove to be helpful. Although we are always hopeful and looking for new therapies, I say, those specific alternatives haven’t worked out. And I end with a promise that I will continue to keep up with the literature and let them know when something new does look promising.

Your responses to the above questions prompts this one: How do physicians who are treating Covid-19 stay on top of what is being learned about Covid-19? At last count, there were 191,968 results in PubMed, found using that sole keyword.

Dr. Lee: One of the amazing things about the Covid era is that members of the scientific community dropped everything to research Covid. But on the flip side, there is now a lot of research out there, and it frankly has become difficult to keep up with it. Our hospital system identified a core group of collaborators with backgrounds such as pharmacy, nursing, infectious disease, pulmonary, and hospital medicine to regularly review the evidence and identify anything that has strong enough evidence to change our system’s clinical practice. Furthermore, I regularly tap consultants in various specialties to help me contextualize new research. And I’ve found it helpful to review the living practice guidelines from the Infectious Disease Society of America and the NIH.^3,6

What else has been remarkable about the last 19 months?

Dr. Lee: I have never spent this much time talking with patients and their caregivers. I’ve always been one to talk a lot with families, but it feels like the pandemic has created another level. My guess is that many colleagues are experiencing the same thing. Caring for hospitalized Covid patients is not only intense from a medical standpoint, but also from a psychosocial vantage point. Patients are ill and usually scared, and they are supported by friends and family who are equally afraid for them, who furthermore can’t visit because of isolation needs. And I often forget that, besides Covid, families have gone through immense social and financial changes. Sometimes communication can be fraught because of that stress. I am trying to be mindful that patients and families come into the hospital with a lot of these burdens, so that, if the conversation takes a tense turn, I will try not to take it personally. Some days are harder than others.

What you are describing isn’t necessarily an innate skill.

Dr. Lee: Absolutely. As have many others, our medical school and residency program has been incorporating communication skills into the standard curriculum, analogous to teaching anatomy or heart failure treatments. We are more aware that handling a difficult conversation isn’t an instinctive thing; that it must be modeled and learned. But I was surprised at how communication in a pandemic, when caretakers can’t see their loved ones, is truly a unique challenge. It is challenging for me despite being in practice for several years.

What will happen when the pandemic subsides? How much of the impact of Covid will stay with you, when dealing with a broken leg, or a patient with osteoporosis?

Dr. Lee: There will be lasting effects of this era on the health-care workforce, but I honestly can’t predict how severe that impact will be or how long-lasting. Already we are seeing health-care workers drop out of the workforce, driven by effects of the pandemic itself, increased workload, or being underpaid.⁷ This is occurring alongside a national conversation that cannot agree on life-saving interventions such as vaccines. I worry that the current environment will lead to many more dropping out.

What can hospital administrators do now to put stop gaps in place? What advice would you give to them?

Dr. Lee: Workers in each hospital will have unique needs and stressors, so it makes sense that the first step is to provide an opportunity to make their opinions heard. It may be tempting for hospitals to jump on quick fixes such as offering classes in “resilience training,” but that may not be a data-driven solution, particularly if burnout is being driven by an ever increasing workload.

Cheryl K. Lee, MD, an Assistant Professor of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency. 
 

Is it fair to say that for hospitalists, the pandemic has been a sobering experience, why so?

Dr. Lee: There are several reasons; one stems from the increasing impact of Covid on children. Early in the pandemic, young children, teens, and young adults were not infected or hospitalized at the rate of older adults.¹ For those of us who care for hospitalized patients, that early finding was somewhat of a relief, knowing at least one portion of the population wasn’t as heavily affected. In fact, I normally split my time as a pediatric and adult hospitalist, and I was reassigned to work full-time in the adult hospital because so few children had been admitted. But all that changed with the arrival of the highly transmissible Delta variant and the loosening of social distancing and masking guidelines and other regulations. The American Academy of Pediatrics² reported that, as of October, 8,364 of every 100,000 children have been infected by Covid, largely driven by  the summer surge. Furthermore, pediatric Covid hospitalizations increased five-fold in August 2021 as compared to the prior 6 weeks. And these numbers likely underestimate the true impact, as several states did not release complete reports and did not account for long-term sequelae from milder infections.

What other issues were far-reaching for hospitalists?

Dr. Lee: Early in 2020, we were scrambling to learn about a novel, deadly, highly transmissible disease. Some groups in our population were experiencing a high fatality rate, and the medical community had no proven treatments. We felt helpless in caring for these patients who pleaded for our help and ultimately died. When data proved that medications like steroids were effective and the vaccines arrived, I had hoped that the pandemic would be ending. But now with the quick dissemination of false information and the evolution of new variants, we are left caring for seriously ill, unvaccinated patients along with younger patients. The heartbreaking thing is that these are largely preventable tragedies now that we have effective vaccines.

What medications have changed the course of Covid in the hospital?

Dr. Lee: Steroids are interesting; they are a good reminder that Covid has different stages and that we should be mindful of how we treat patients within those particular stages. Simply, Covid infection begins with a phase of viral replication characterized by fevers, cough, loss of taste and smell, and gastrointestinal symptoms. In time, this is followed by a second phase of high inflammation and immune response, sometimes causing hypoxemia and respiratory failure. What we know is that steroids such as dexamethasone reduce mortality, but they are only effective during this second phase, and only in those whose oxygen levels are low enough to require oxygen. This was not an intuitive finding, since steroids do not help, and may harm, those with other viral pneumonias, such as influenza. Steroid use in severe, hypoxemic Covid, however, is life-saving and the mainstay of inpatient care which might include antivirals and interleukin-6 inhibitors³ in select patients. As with steroid use in other patients, physicians should watch their Covid patients for hyperglycemia⁴ and delirium. That said, steroids provide a  mortality benefit that strongly supports their continued use -- in tandem with management of those expected side effects. Last, it is important to note that steroid use has been associated with possible harm when given to those with mild Covid,⁵ so its use should be avoided, in light of its expected side effects, unless a patient requires supplemental oxygen.

That said, although steroids can be helpful for our sickest patients, vaccines are the best medicine of all because they can allow patients to avoid hospitalization and death  -- outcomes that far outweigh what steroids or any other medication can do for the gravely ill.

Given the complexity of the evidence surrounding the treatments for Covid in the hospital, no wonder some people are confused about which medicines work.

Dr. Lee: First, let me say that I have yet to encounter a patient or family member whose motivation to ask questions or question a loved one’s treatment wasn’t grounded in concern and fear for their loved one.

What do they ask about?

Dr. Lee: They ask about alternative treatments, anti-parasitics, even vitamins. I agree with them that there is so much out there about Covid that it is difficult for anyone to know what is true or false. I then explain what therapies are proven – medications such as steroids and supportive care such as oxygen and prone positioning. I also review the lack of good evidence for the alternative treatments that they ask about. It is sometimes surprising to folks that all research isn’t conducted with equal rigor, and that false conclusions can be made based on faulty evidence. A good example is how providers used hydroxychloroquine early in the pandemic, but ultimately it didn’t prove to be helpful. Although we are always hopeful and looking for new therapies, I say, those specific alternatives haven’t worked out. And I end with a promise that I will continue to keep up with the literature and let them know when something new does look promising.

Your responses to the above questions prompts this one: How do physicians who are treating Covid-19 stay on top of what is being learned about Covid-19? At last count, there were 191,968 results in PubMed, found using that sole keyword.

Dr. Lee: One of the amazing things about the Covid era is that members of the scientific community dropped everything to research Covid. But on the flip side, there is now a lot of research out there, and it frankly has become difficult to keep up with it. Our hospital system identified a core group of collaborators with backgrounds such as pharmacy, nursing, infectious disease, pulmonary, and hospital medicine to regularly review the evidence and identify anything that has strong enough evidence to change our system’s clinical practice. Furthermore, I regularly tap consultants in various specialties to help me contextualize new research. And I’ve found it helpful to review the living practice guidelines from the Infectious Disease Society of America and the NIH.^3,6

What else has been remarkable about the last 19 months?

Dr. Lee: I have never spent this much time talking with patients and their caregivers. I’ve always been one to talk a lot with families, but it feels like the pandemic has created another level. My guess is that many colleagues are experiencing the same thing. Caring for hospitalized Covid patients is not only intense from a medical standpoint, but also from a psychosocial vantage point. Patients are ill and usually scared, and they are supported by friends and family who are equally afraid for them, who furthermore can’t visit because of isolation needs. And I often forget that, besides Covid, families have gone through immense social and financial changes. Sometimes communication can be fraught because of that stress. I am trying to be mindful that patients and families come into the hospital with a lot of these burdens, so that, if the conversation takes a tense turn, I will try not to take it personally. Some days are harder than others.

What you are describing isn’t necessarily an innate skill.

Dr. Lee: Absolutely. As have many others, our medical school and residency program has been incorporating communication skills into the standard curriculum, analogous to teaching anatomy or heart failure treatments. We are more aware that handling a difficult conversation isn’t an instinctive thing; that it must be modeled and learned. But I was surprised at how communication in a pandemic, when caretakers can’t see their loved ones, is truly a unique challenge. It is challenging for me despite being in practice for several years.

What will happen when the pandemic subsides? How much of the impact of Covid will stay with you, when dealing with a broken leg, or a patient with osteoporosis?

Dr. Lee: There will be lasting effects of this era on the health-care workforce, but I honestly can’t predict how severe that impact will be or how long-lasting. Already we are seeing health-care workers drop out of the workforce, driven by effects of the pandemic itself, increased workload, or being underpaid.⁷ This is occurring alongside a national conversation that cannot agree on life-saving interventions such as vaccines. I worry that the current environment will lead to many more dropping out.

What can hospital administrators do now to put stop gaps in place? What advice would you give to them?

Dr. Lee: Workers in each hospital will have unique needs and stressors, so it makes sense that the first step is to provide an opportunity to make their opinions heard. It may be tempting for hospitals to jump on quick fixes such as offering classes in “resilience training,” but that may not be a data-driven solution, particularly if burnout is being driven by an ever increasing workload.

Cheryl K. Lee, MD, an Assistant Professor of Medicine at Northwestern Feinberg School of Medicine, practices internal medicine and pediatrics at Northwestern Memorial and the Ann & Robert H. Lurie Children's Hospital, both in Chicago, IL. She also serves on the Northwestern Medicine Covid Quality Committee and as core clinical faculty in the Internal Medicine Residency. 
 

Is it fair to say that for hospitalists, the pandemic has been a sobering experience, why so?

Dr. Lee: There are several reasons; one stems from the increasing impact of Covid on children. Early in the pandemic, young children, teens, and young adults were not infected or hospitalized at the rate of older adults.¹ For those of us who care for hospitalized patients, that early finding was somewhat of a relief, knowing at least one portion of the population wasn’t as heavily affected. In fact, I normally split my time as a pediatric and adult hospitalist, and I was reassigned to work full-time in the adult hospital because so few children had been admitted. But all that changed with the arrival of the highly transmissible Delta variant and the loosening of social distancing and masking guidelines and other regulations. The American Academy of Pediatrics² reported that, as of October, 8,364 of every 100,000 children have been infected by Covid, largely driven by  the summer surge. Furthermore, pediatric Covid hospitalizations increased five-fold in August 2021 as compared to the prior 6 weeks. And these numbers likely underestimate the true impact, as several states did not release complete reports and did not account for long-term sequelae from milder infections.

What other issues were far-reaching for hospitalists?

Dr. Lee: Early in 2020, we were scrambling to learn about a novel, deadly, highly transmissible disease. Some groups in our population were experiencing a high fatality rate, and the medical community had no proven treatments. We felt helpless in caring for these patients who pleaded for our help and ultimately died. When data proved that medications like steroids were effective and the vaccines arrived, I had hoped that the pandemic would be ending. But now with the quick dissemination of false information and the evolution of new variants, we are left caring for seriously ill, unvaccinated patients along with younger patients. The heartbreaking thing is that these are largely preventable tragedies now that we have effective vaccines.

What medications have changed the course of Covid in the hospital?

Dr. Lee: Steroids are interesting; they are a good reminder that Covid has different stages and that we should be mindful of how we treat patients within those particular stages. Simply, Covid infection begins with a phase of viral replication characterized by fevers, cough, loss of taste and smell, and gastrointestinal symptoms. In time, this is followed by a second phase of high inflammation and immune response, sometimes causing hypoxemia and respiratory failure. What we know is that steroids such as dexamethasone reduce mortality, but they are only effective during this second phase, and only in those whose oxygen levels are low enough to require oxygen. This was not an intuitive finding, since steroids do not help, and may harm, those with other viral pneumonias, such as influenza. Steroid use in severe, hypoxemic Covid, however, is life-saving and the mainstay of inpatient care which might include antivirals and interleukin-6 inhibitors³ in select patients. As with steroid use in other patients, physicians should watch their Covid patients for hyperglycemia⁴ and delirium. That said, steroids provide a  mortality benefit that strongly supports their continued use -- in tandem with management of those expected side effects. Last, it is important to note that steroid use has been associated with possible harm when given to those with mild Covid,⁵ so its use should be avoided, in light of its expected side effects, unless a patient requires supplemental oxygen.

That said, although steroids can be helpful for our sickest patients, vaccines are the best medicine of all because they can allow patients to avoid hospitalization and death  -- outcomes that far outweigh what steroids or any other medication can do for the gravely ill.

Given the complexity of the evidence surrounding the treatments for Covid in the hospital, no wonder some people are confused about which medicines work.

Dr. Lee: First, let me say that I have yet to encounter a patient or family member whose motivation to ask questions or question a loved one’s treatment wasn’t grounded in concern and fear for their loved one.

What do they ask about?

Dr. Lee: They ask about alternative treatments, anti-parasitics, even vitamins. I agree with them that there is so much out there about Covid that it is difficult for anyone to know what is true or false. I then explain what therapies are proven – medications such as steroids and supportive care such as oxygen and prone positioning. I also review the lack of good evidence for the alternative treatments that they ask about. It is sometimes surprising to folks that all research isn’t conducted with equal rigor, and that false conclusions can be made based on faulty evidence. A good example is how providers used hydroxychloroquine early in the pandemic, but ultimately it didn’t prove to be helpful. Although we are always hopeful and looking for new therapies, I say, those specific alternatives haven’t worked out. And I end with a promise that I will continue to keep up with the literature and let them know when something new does look promising.

Your responses to the above questions prompts this one: How do physicians who are treating Covid-19 stay on top of what is being learned about Covid-19? At last count, there were 191,968 results in PubMed, found using that sole keyword.

Dr. Lee: One of the amazing things about the Covid era is that members of the scientific community dropped everything to research Covid. But on the flip side, there is now a lot of research out there, and it frankly has become difficult to keep up with it. Our hospital system identified a core group of collaborators with backgrounds such as pharmacy, nursing, infectious disease, pulmonary, and hospital medicine to regularly review the evidence and identify anything that has strong enough evidence to change our system’s clinical practice. Furthermore, I regularly tap consultants in various specialties to help me contextualize new research. And I’ve found it helpful to review the living practice guidelines from the Infectious Disease Society of America and the NIH.^3,6

What else has been remarkable about the last 19 months?

Dr. Lee: I have never spent this much time talking with patients and their caregivers. I’ve always been one to talk a lot with families, but it feels like the pandemic has created another level. My guess is that many colleagues are experiencing the same thing. Caring for hospitalized Covid patients is not only intense from a medical standpoint, but also from a psychosocial vantage point. Patients are ill and usually scared, and they are supported by friends and family who are equally afraid for them, who furthermore can’t visit because of isolation needs. And I often forget that, besides Covid, families have gone through immense social and financial changes. Sometimes communication can be fraught because of that stress. I am trying to be mindful that patients and families come into the hospital with a lot of these burdens, so that, if the conversation takes a tense turn, I will try not to take it personally. Some days are harder than others.

What you are describing isn’t necessarily an innate skill.

Dr. Lee: Absolutely. As have many others, our medical school and residency program has been incorporating communication skills into the standard curriculum, analogous to teaching anatomy or heart failure treatments. We are more aware that handling a difficult conversation isn’t an instinctive thing; that it must be modeled and learned. But I was surprised at how communication in a pandemic, when caretakers can’t see their loved ones, is truly a unique challenge. It is challenging for me despite being in practice for several years.

What will happen when the pandemic subsides? How much of the impact of Covid will stay with you, when dealing with a broken leg, or a patient with osteoporosis?

Dr. Lee: There will be lasting effects of this era on the health-care workforce, but I honestly can’t predict how severe that impact will be or how long-lasting. Already we are seeing health-care workers drop out of the workforce, driven by effects of the pandemic itself, increased workload, or being underpaid.⁷ This is occurring alongside a national conversation that cannot agree on life-saving interventions such as vaccines. I worry that the current environment will lead to many more dropping out.

What can hospital administrators do now to put stop gaps in place? What advice would you give to them?

Dr. Lee: Workers in each hospital will have unique needs and stressors, so it makes sense that the first step is to provide an opportunity to make their opinions heard. It may be tempting for hospitals to jump on quick fixes such as offering classes in “resilience training,” but that may not be a data-driven solution, particularly if burnout is being driven by an ever increasing workload.

Key clinical point: Enucleation of submucous uterine fibroids (UF) under hysteroscopy can be achieved by a modified resectoscopic slicing using a bipolar loop, which appeared safe and faster compared with classical resectoscopic myomectomy.

Major finding: Mean operation time (22.9 minutes vs 38.9 minutes; P < .001) and volume of mean distending media (1,495.6 mL vs 2,393.1 mL; P < .001) were significantly shorter in the modified vs classical resectoscopic slicing group. The classical group witnessed 3 cases of fluid overload and 1 case of uterine perforation, whereas none of these postoperative complications occurred in the modified technique group.

Study details: Findings are from a retrospective study including 55 women with submucous UFs, of which 19 women underwent modified resectoscopic slicing and 36 women underwent the classical resectoscopic myomectomy.

Disclosures: This study was funded by Shanghai Municipal Health Commission, China. The authors declared no conflict of interests.

Source: Zhang W et al. Front Surg. 2021 Nov 10. doi: 10.3389/fsurg.2021.746936.

Key clinical point: Enucleation of submucous uterine fibroids (UF) under hysteroscopy can be achieved by a modified resectoscopic slicing using a bipolar loop, which appeared safe and faster compared with classical resectoscopic myomectomy.

Major finding: Mean operation time (22.9 minutes vs 38.9 minutes; P < .001) and volume of mean distending media (1,495.6 mL vs 2,393.1 mL; P < .001) were significantly shorter in the modified vs classical resectoscopic slicing group. The classical group witnessed 3 cases of fluid overload and 1 case of uterine perforation, whereas none of these postoperative complications occurred in the modified technique group.

Study details: Findings are from a retrospective study including 55 women with submucous UFs, of which 19 women underwent modified resectoscopic slicing and 36 women underwent the classical resectoscopic myomectomy.

Disclosures: This study was funded by Shanghai Municipal Health Commission, China. The authors declared no conflict of interests.

Source: Zhang W et al. Front Surg. 2021 Nov 10. doi: 10.3389/fsurg.2021.746936.

Key clinical point: Enucleation of submucous uterine fibroids (UF) under hysteroscopy can be achieved by a modified resectoscopic slicing using a bipolar loop, which appeared safe and faster compared with classical resectoscopic myomectomy.

Major finding: Mean operation time (22.9 minutes vs 38.9 minutes; P < .001) and volume of mean distending media (1,495.6 mL vs 2,393.1 mL; P < .001) were significantly shorter in the modified vs classical resectoscopic slicing group. The classical group witnessed 3 cases of fluid overload and 1 case of uterine perforation, whereas none of these postoperative complications occurred in the modified technique group.

Study details: Findings are from a retrospective study including 55 women with submucous UFs, of which 19 women underwent modified resectoscopic slicing and 36 women underwent the classical resectoscopic myomectomy.

Disclosures: This study was funded by Shanghai Municipal Health Commission, China. The authors declared no conflict of interests.

Source: Zhang W et al. Front Surg. 2021 Nov 10. doi: 10.3389/fsurg.2021.746936.

Key clinical point: Rates of reintervention were similar, and the risk for major adverse events was lower with thermal ablative methods vs myomectomy for treating uterine fibroids (UF), suggesting that thermal ablative methods were not inferior to myomectomy for treating UFs.

Major finding: The reintervention rate was not significantly different between thermal ablative treatment and myomectomy in randomized controlled trials (RCTs; P = .094) and observational studies (P = .16). The risk for major adverse events was significantly lower with thermal ablative methods (risk ratio, 0.111; 95% CI, 0.070-0.175). The pregnancy rate was not significantly different between the groups (P = .796).

Study details: Findings are from a meta-analysis of 10 observational studies and 3 RCTs including 4,205 patients who underwent thermal ablative methods or myomectomy for the treatment of UFs.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Liang D et al. Int J Hyperthermia. 2021 Nov 1. doi: 10.1080/02656736.2021.1996644.

Key clinical point: Rates of reintervention were similar, and the risk for major adverse events was lower with thermal ablative methods vs myomectomy for treating uterine fibroids (UF), suggesting that thermal ablative methods were not inferior to myomectomy for treating UFs.

Major finding: The reintervention rate was not significantly different between thermal ablative treatment and myomectomy in randomized controlled trials (RCTs; P = .094) and observational studies (P = .16). The risk for major adverse events was significantly lower with thermal ablative methods (risk ratio, 0.111; 95% CI, 0.070-0.175). The pregnancy rate was not significantly different between the groups (P = .796).

Study details: Findings are from a meta-analysis of 10 observational studies and 3 RCTs including 4,205 patients who underwent thermal ablative methods or myomectomy for the treatment of UFs.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Liang D et al. Int J Hyperthermia. 2021 Nov 1. doi: 10.1080/02656736.2021.1996644.

Key clinical point: Rates of reintervention were similar, and the risk for major adverse events was lower with thermal ablative methods vs myomectomy for treating uterine fibroids (UF), suggesting that thermal ablative methods were not inferior to myomectomy for treating UFs.

Major finding: The reintervention rate was not significantly different between thermal ablative treatment and myomectomy in randomized controlled trials (RCTs; P = .094) and observational studies (P = .16). The risk for major adverse events was significantly lower with thermal ablative methods (risk ratio, 0.111; 95% CI, 0.070-0.175). The pregnancy rate was not significantly different between the groups (P = .796).

Study details: Findings are from a meta-analysis of 10 observational studies and 3 RCTs including 4,205 patients who underwent thermal ablative methods or myomectomy for the treatment of UFs.

Disclosures: This study did not report any source of funding. The authors declared no conflict of interests.

Source: Liang D et al. Int J Hyperthermia. 2021 Nov 1. doi: 10.1080/02656736.2021.1996644.

Key clinical point: Hysteromyoma enucleation performed simultaneously during the cesarean section (C-section) is safe without any surgical complications in pregnant women with anterior uterine fibroids (UF).

Major finding: The operation time (median, 83.3 minutes vs 72.5 minutes; P = .04) and postoperative hospital stays (median, 3.6 days vs 3.2 days; P = .01) were slightly longer in the group of patients whose UFs were removed by C-section incision vs those who were operated traditionally by an incision through the serous layer. Pre- and postoperative hemoglobin level, intraoperative bleeding, frequency of blood transfusion, postpartum hemorrhage, and fever were similar between both groups, with no postoperative complications observed in either group.

Study details: Findings are from a retrospective analysis of 90 pregnant women with anterior UFs who underwent hysteromyoma enucleation simultaneously during C-section.

Disclosures: This study was funded by the Fujian Provincial Maternity and Children’s Hospital Science Foundation. The authors declared no conflict of interests.

Source: Dai Y et al. BMC Pregnancy Childbirth. 2021 Nov 3. doi: 10.1186/s12884-021-04226-1.

Key clinical point: Hysteromyoma enucleation performed simultaneously during the cesarean section (C-section) is safe without any surgical complications in pregnant women with anterior uterine fibroids (UF).

Major finding: The operation time (median, 83.3 minutes vs 72.5 minutes; P = .04) and postoperative hospital stays (median, 3.6 days vs 3.2 days; P = .01) were slightly longer in the group of patients whose UFs were removed by C-section incision vs those who were operated traditionally by an incision through the serous layer. Pre- and postoperative hemoglobin level, intraoperative bleeding, frequency of blood transfusion, postpartum hemorrhage, and fever were similar between both groups, with no postoperative complications observed in either group.

Study details: Findings are from a retrospective analysis of 90 pregnant women with anterior UFs who underwent hysteromyoma enucleation simultaneously during C-section.

Disclosures: This study was funded by the Fujian Provincial Maternity and Children’s Hospital Science Foundation. The authors declared no conflict of interests.

Source: Dai Y et al. BMC Pregnancy Childbirth. 2021 Nov 3. doi: 10.1186/s12884-021-04226-1.

Key clinical point: Hysteromyoma enucleation performed simultaneously during the cesarean section (C-section) is safe without any surgical complications in pregnant women with anterior uterine fibroids (UF).

Major finding: The operation time (median, 83.3 minutes vs 72.5 minutes; P = .04) and postoperative hospital stays (median, 3.6 days vs 3.2 days; P = .01) were slightly longer in the group of patients whose UFs were removed by C-section incision vs those who were operated traditionally by an incision through the serous layer. Pre- and postoperative hemoglobin level, intraoperative bleeding, frequency of blood transfusion, postpartum hemorrhage, and fever were similar between both groups, with no postoperative complications observed in either group.

Study details: Findings are from a retrospective analysis of 90 pregnant women with anterior UFs who underwent hysteromyoma enucleation simultaneously during C-section.

Disclosures: This study was funded by the Fujian Provincial Maternity and Children’s Hospital Science Foundation. The authors declared no conflict of interests.

Source: Dai Y et al. BMC Pregnancy Childbirth. 2021 Nov 3. doi: 10.1186/s12884-021-04226-1.