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Study spotlights body image dissatisfaction in pediatric IBD
LAS VEGAS – Among current steroid use, higher body mass index percentile, and comorbid mood disorder.
The findings come from a cross-sectional study of 664 patients enrolled in the Crohn’s & Colitis Foundation’s Partners Kids & Teens cohort, presented by Jennifer Claytor, MS, at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Ms. Claytor, a fourth-year medical student at the University of North Carolina at Chapel Hill, and her associates asked study participants aged 5-18 years to complete surveys on demographics, disease characteristics, and the IMPACT-35 questionnaire and Patient-Reported Outcomes Measurement Information System (PROMIS) tools for assessment of psychological patient-reported outcomes. The pediatric ulcerative colitis activity index and the short Crohn’s disease activity index were used to measure disease activity.
The researchers classified body image dissatisfaction as being present if the patients selected “I look awful” or “I look bad” from the list of possible responses to the question, “How do you feel about the way you look?” Next, they performed bivariate analyses to assess associations between body image dissatisfaction and demographic, disease-related, and psychosocial factors and created logistic regression models to evaluate independent associations between selected risk factors and body image dissatisfaction. “There has been some literature which suggests that for boys, weight and not body image dissatisfaction predicts worse psychosocial outcomes,” Ms. Claytor said. “But for girls it’s body image dissatisfaction, irrespective of weight.”
Of the 664 patients, 74 (3.3%) met criteria for body image dissatisfaction. Compared with patients who did not meet criteria for body image dissatisfaction, those who did were significantly more likely to be female (69% vs. 44%, respectively; P less than .001), older (mean age of 15 vs. 13 years; P less than .001), and diagnosed with IBD an older age (median of 12 vs. 10 years; P less than .001). Ms. Claytor and her associates also found that individuals with body image dissatisfaction had a higher median BMI percentile (P = .02), higher rates of active disease (57% vs. 26%; P less than .001), higher rates of current steroid use (18% vs. 8%; P = .004), and higher rates of depression and anxiety (P less than .001).
After adjusting for age, body mass index, remission, steroid use, and other factors, the odds for developing body image dissatisfaction was highest among those with anxiety (odds ratio, 5.42), followed by depression (OR, 4.73), female gender (OR, 2.31), and current steroid use (OR, 1.59). “I think this points to the need for enhanced counseling services and being aware of these characteristics,” Ms. Claytor said. She reported having no financial disclosures.
SOURCE: Claytor J et al. Crohn’s & Colitis Congress, Poster 15.
*This story was updated on 3/26.
LAS VEGAS – Among current steroid use, higher body mass index percentile, and comorbid mood disorder.
The findings come from a cross-sectional study of 664 patients enrolled in the Crohn’s & Colitis Foundation’s Partners Kids & Teens cohort, presented by Jennifer Claytor, MS, at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Ms. Claytor, a fourth-year medical student at the University of North Carolina at Chapel Hill, and her associates asked study participants aged 5-18 years to complete surveys on demographics, disease characteristics, and the IMPACT-35 questionnaire and Patient-Reported Outcomes Measurement Information System (PROMIS) tools for assessment of psychological patient-reported outcomes. The pediatric ulcerative colitis activity index and the short Crohn’s disease activity index were used to measure disease activity.
The researchers classified body image dissatisfaction as being present if the patients selected “I look awful” or “I look bad” from the list of possible responses to the question, “How do you feel about the way you look?” Next, they performed bivariate analyses to assess associations between body image dissatisfaction and demographic, disease-related, and psychosocial factors and created logistic regression models to evaluate independent associations between selected risk factors and body image dissatisfaction. “There has been some literature which suggests that for boys, weight and not body image dissatisfaction predicts worse psychosocial outcomes,” Ms. Claytor said. “But for girls it’s body image dissatisfaction, irrespective of weight.”
Of the 664 patients, 74 (3.3%) met criteria for body image dissatisfaction. Compared with patients who did not meet criteria for body image dissatisfaction, those who did were significantly more likely to be female (69% vs. 44%, respectively; P less than .001), older (mean age of 15 vs. 13 years; P less than .001), and diagnosed with IBD an older age (median of 12 vs. 10 years; P less than .001). Ms. Claytor and her associates also found that individuals with body image dissatisfaction had a higher median BMI percentile (P = .02), higher rates of active disease (57% vs. 26%; P less than .001), higher rates of current steroid use (18% vs. 8%; P = .004), and higher rates of depression and anxiety (P less than .001).
After adjusting for age, body mass index, remission, steroid use, and other factors, the odds for developing body image dissatisfaction was highest among those with anxiety (odds ratio, 5.42), followed by depression (OR, 4.73), female gender (OR, 2.31), and current steroid use (OR, 1.59). “I think this points to the need for enhanced counseling services and being aware of these characteristics,” Ms. Claytor said. She reported having no financial disclosures.
SOURCE: Claytor J et al. Crohn’s & Colitis Congress, Poster 15.
*This story was updated on 3/26.
LAS VEGAS – Among current steroid use, higher body mass index percentile, and comorbid mood disorder.
The findings come from a cross-sectional study of 664 patients enrolled in the Crohn’s & Colitis Foundation’s Partners Kids & Teens cohort, presented by Jennifer Claytor, MS, at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Ms. Claytor, a fourth-year medical student at the University of North Carolina at Chapel Hill, and her associates asked study participants aged 5-18 years to complete surveys on demographics, disease characteristics, and the IMPACT-35 questionnaire and Patient-Reported Outcomes Measurement Information System (PROMIS) tools for assessment of psychological patient-reported outcomes. The pediatric ulcerative colitis activity index and the short Crohn’s disease activity index were used to measure disease activity.
The researchers classified body image dissatisfaction as being present if the patients selected “I look awful” or “I look bad” from the list of possible responses to the question, “How do you feel about the way you look?” Next, they performed bivariate analyses to assess associations between body image dissatisfaction and demographic, disease-related, and psychosocial factors and created logistic regression models to evaluate independent associations between selected risk factors and body image dissatisfaction. “There has been some literature which suggests that for boys, weight and not body image dissatisfaction predicts worse psychosocial outcomes,” Ms. Claytor said. “But for girls it’s body image dissatisfaction, irrespective of weight.”
Of the 664 patients, 74 (3.3%) met criteria for body image dissatisfaction. Compared with patients who did not meet criteria for body image dissatisfaction, those who did were significantly more likely to be female (69% vs. 44%, respectively; P less than .001), older (mean age of 15 vs. 13 years; P less than .001), and diagnosed with IBD an older age (median of 12 vs. 10 years; P less than .001). Ms. Claytor and her associates also found that individuals with body image dissatisfaction had a higher median BMI percentile (P = .02), higher rates of active disease (57% vs. 26%; P less than .001), higher rates of current steroid use (18% vs. 8%; P = .004), and higher rates of depression and anxiety (P less than .001).
After adjusting for age, body mass index, remission, steroid use, and other factors, the odds for developing body image dissatisfaction was highest among those with anxiety (odds ratio, 5.42), followed by depression (OR, 4.73), female gender (OR, 2.31), and current steroid use (OR, 1.59). “I think this points to the need for enhanced counseling services and being aware of these characteristics,” Ms. Claytor said. She reported having no financial disclosures.
SOURCE: Claytor J et al. Crohn’s & Colitis Congress, Poster 15.
*This story was updated on 3/26.
REPORTING FROM CROHN’S & COLITIS CONGRESS
Key clinical point: Interventions to target modifiable risk factors for body image dissatisfaction may improve quality of life in pediatric IBD patients.
Major finding: The odds for developing body image dissatisfaction were highest among those with anxiety (odds ratio, 5.42), followed by depression (OR, 4.73) and female gender (OR, 2.31).
Study details: A cross-sectional study of 664 patients enrolled in the Crohn’s & Colitis Foundation’s Partners Kids & Teens cohort.
Disclosures: Ms. Claytor reported having no financial disclosures.
Source: Claytor J et al. Crohn’s & Colitis Congress, Poster 15.
Bladder cancer: Two chemoradiation therapy regimens on par for muscle-invasive disease
SAN FRANCISCO – Two concurrent chemoradiation induction regimens had similar safety and efficacy when used as part of a bladder-sparing strategy in patients with muscle-invasive bladder cancer, suggest primary results of the NRG/RTOG 0712 trial. But one offers better patient convenience.
The selective bladder-preservation paradigm entails maximal transurethral resection of the bladder tumor (TURBT) followed by induction radiation and concomitant chemotherapy, lead author John J. Coen, MD, a radiation oncologist with 21st Century Oncology, Providence, Rhode Island, noted at the 2018 Genitourinary Cancers Symposium. Patients then undergo cystoscopy to assess their response.
“A key component of this therapy is close urologic surveillance,” he noted. “This is trimodality therapy with close urologic surveillance, and cystectomy is prompted at the earliest time it’s indicated.”
The 70 patients enrolled in the multicenter randomized phase 2 trial had undergone TURBT and were randomized evenly to twice-daily radiation plus 5-flourouracil-cisplatin (the RTOG standard at the time of trial planning) or to daily radiation plus gemcitabine (a modification of a successful regimen developed at the University of Michigan). All were offered adjuvant chemotherapy regardless of whether they responded and whether they underwent consolidation therapy or cystectomy.
At a median follow-up of 5.1 years among the 52 evaluable patients, the 3-year rate of freedom from distant metastasis, the trial’s primary endpoint, was 78% with twice-daily radiation plus 5-flourouracil-cisplatin and 84% with daily radiation plus gemcitabine, according to results reported at the symposium, which was sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
Both values were higher than the trial’s predefined benchmark of 75% for defining the regimen as promising. “This trial wasn’t necessarily powered to compare arms, so the conclusion would be that both arms exceeded the benchmark and it would be appropriate to evaluate both arms further in subsequent trials,” Dr. Coen commented.
In each trial arm, more than three-fourths of patients had a complete response, and about two-thirds of patients were alive and free of distant metastasis with their bladder intact at 3 years.
Toxicity, which was supposed to be the tie-breaker if efficacy was similar, was also essentially the same for the two regimens. Both were fairly well tolerated in the acute period; the primary grade 3 and 4 toxicities were hematologic ones.
“So where do we go from here? I think this trial does demonstrate concurrent gemcitabine is a reasonable alternative to cisplatin for patients undergoing selective bladder preservation,” Dr. Coen summarized. “This is especially important in patients with poor renal function or hearing loss. And bladder cancer is often a disease in the elderly, so tolerance of various regimens is a very important aspect to planning further trials.”
“This trial also demonstrates that daily radiation is a reasonable alternative to twice-a-day radiation, which had become the standard through the RTOG on more contemporary trials,” he added. “Daily radiation would allow wider adoption of selective bladder preservation by trimodality therapy.”
Clinical implications
“I would have to see more details about the toxicity data for the chemotherapy, the radiosensitizers,” session co-chair Yair Lotan, MD, a professor of urology at the UT Southwestern Medical Center, Dallas, Texas, commented in an interview. “But in general, if you have two equivalent protocols in terms of effectiveness, and one is less toxic or more convenient, that’s always preferable. From the standpoint of coming once a day rather than twice a day to get radiation, if I were a patient, I would prefer that regimen”
Current practice in this patient population likely hinges on where a patient is treated, he said. “Based on the new nonmetastatic muscle-invasive guidelines, many of them would be recommended surgery or possibly chemoradiation protocols, and then there are a lot of factors such as patient preference and outcomes that would probably impact the decision making.”
“Certainly, this study won’t prove standard of care because standard of care in the global picture for a patient with muscle-invasive disease really will depend on a randomized trial of surgery versus radiation or chemoradiation, multimodal therapies,” Dr. Lotan maintained. “Not every patient is even eligible; some patients with hydronephrosis or unresectable disease may not be the best candidates for multimodal therapy. But more information from these types of trials may help clinicians decide which multimodal therapy approach to use.”
Study details
Patients enrolled in NRG/RTOG 0712, a multicenter randomized phase 2 trial supported by the National Cancer Institute, had clinical T2 or T3-4a bladder cancer. Hydronephrosis and obvious lymph node involvement were exclusion criteria.
Like the rate of freedom from metastasis, the rate of complete response after induction therapy was similar for the two arms: 87.9% with twice-daily radiation plus 5-flourouracil-cisplatin and 75.8% with daily radiation plus gemcitabine.
“These rates exceed historical complete response rates, and this is likely a result of improved selection over time and more thorough TURBTs performed over time,” Dr. Coen proposed. “Over the course of multiple successive RTOG trials, our selection criteria have been refined. One excellent example would be that hydronephrosis has been excluded on more contemporary trials, but if you look at older trials, those patients were included.”
The 3-year rate of bladder-intact distant metastasis–free survival was 66.7% and 69%, respectively. “This is a very important endpoint. These results are excellent,” he commented. “And there is really no appreciable difference between the two arms on the actuarial analysis.”
As far as specific treatment failure events in the trial overall, three patients died, eight underwent cystectomy, and eight developed distant metastases. Although numbers were small, these events appeared fairly evenly distributed across arms.
The rate of grade 3 or 4 acute toxicity was 57.6% with twice-daily radiation plus 5-flourouracil-cisplatin and 54.6% with daily radiation plus gemcitabine. The large majority of events were blood and bone marrow toxicity. “It’s quite notable that the rates of GU and GI toxicity were very low,” commented Dr. Coen, who disclosed that he had no relevant conflicts of interest.
SOURCE: Coen, J. et al, 2018 Genitourinary Cancers Symposium, Abstract 408
SAN FRANCISCO – Two concurrent chemoradiation induction regimens had similar safety and efficacy when used as part of a bladder-sparing strategy in patients with muscle-invasive bladder cancer, suggest primary results of the NRG/RTOG 0712 trial. But one offers better patient convenience.
The selective bladder-preservation paradigm entails maximal transurethral resection of the bladder tumor (TURBT) followed by induction radiation and concomitant chemotherapy, lead author John J. Coen, MD, a radiation oncologist with 21st Century Oncology, Providence, Rhode Island, noted at the 2018 Genitourinary Cancers Symposium. Patients then undergo cystoscopy to assess their response.
“A key component of this therapy is close urologic surveillance,” he noted. “This is trimodality therapy with close urologic surveillance, and cystectomy is prompted at the earliest time it’s indicated.”
The 70 patients enrolled in the multicenter randomized phase 2 trial had undergone TURBT and were randomized evenly to twice-daily radiation plus 5-flourouracil-cisplatin (the RTOG standard at the time of trial planning) or to daily radiation plus gemcitabine (a modification of a successful regimen developed at the University of Michigan). All were offered adjuvant chemotherapy regardless of whether they responded and whether they underwent consolidation therapy or cystectomy.
At a median follow-up of 5.1 years among the 52 evaluable patients, the 3-year rate of freedom from distant metastasis, the trial’s primary endpoint, was 78% with twice-daily radiation plus 5-flourouracil-cisplatin and 84% with daily radiation plus gemcitabine, according to results reported at the symposium, which was sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
Both values were higher than the trial’s predefined benchmark of 75% for defining the regimen as promising. “This trial wasn’t necessarily powered to compare arms, so the conclusion would be that both arms exceeded the benchmark and it would be appropriate to evaluate both arms further in subsequent trials,” Dr. Coen commented.
In each trial arm, more than three-fourths of patients had a complete response, and about two-thirds of patients were alive and free of distant metastasis with their bladder intact at 3 years.
Toxicity, which was supposed to be the tie-breaker if efficacy was similar, was also essentially the same for the two regimens. Both were fairly well tolerated in the acute period; the primary grade 3 and 4 toxicities were hematologic ones.
“So where do we go from here? I think this trial does demonstrate concurrent gemcitabine is a reasonable alternative to cisplatin for patients undergoing selective bladder preservation,” Dr. Coen summarized. “This is especially important in patients with poor renal function or hearing loss. And bladder cancer is often a disease in the elderly, so tolerance of various regimens is a very important aspect to planning further trials.”
“This trial also demonstrates that daily radiation is a reasonable alternative to twice-a-day radiation, which had become the standard through the RTOG on more contemporary trials,” he added. “Daily radiation would allow wider adoption of selective bladder preservation by trimodality therapy.”
Clinical implications
“I would have to see more details about the toxicity data for the chemotherapy, the radiosensitizers,” session co-chair Yair Lotan, MD, a professor of urology at the UT Southwestern Medical Center, Dallas, Texas, commented in an interview. “But in general, if you have two equivalent protocols in terms of effectiveness, and one is less toxic or more convenient, that’s always preferable. From the standpoint of coming once a day rather than twice a day to get radiation, if I were a patient, I would prefer that regimen”
Current practice in this patient population likely hinges on where a patient is treated, he said. “Based on the new nonmetastatic muscle-invasive guidelines, many of them would be recommended surgery or possibly chemoradiation protocols, and then there are a lot of factors such as patient preference and outcomes that would probably impact the decision making.”
“Certainly, this study won’t prove standard of care because standard of care in the global picture for a patient with muscle-invasive disease really will depend on a randomized trial of surgery versus radiation or chemoradiation, multimodal therapies,” Dr. Lotan maintained. “Not every patient is even eligible; some patients with hydronephrosis or unresectable disease may not be the best candidates for multimodal therapy. But more information from these types of trials may help clinicians decide which multimodal therapy approach to use.”
Study details
Patients enrolled in NRG/RTOG 0712, a multicenter randomized phase 2 trial supported by the National Cancer Institute, had clinical T2 or T3-4a bladder cancer. Hydronephrosis and obvious lymph node involvement were exclusion criteria.
Like the rate of freedom from metastasis, the rate of complete response after induction therapy was similar for the two arms: 87.9% with twice-daily radiation plus 5-flourouracil-cisplatin and 75.8% with daily radiation plus gemcitabine.
“These rates exceed historical complete response rates, and this is likely a result of improved selection over time and more thorough TURBTs performed over time,” Dr. Coen proposed. “Over the course of multiple successive RTOG trials, our selection criteria have been refined. One excellent example would be that hydronephrosis has been excluded on more contemporary trials, but if you look at older trials, those patients were included.”
The 3-year rate of bladder-intact distant metastasis–free survival was 66.7% and 69%, respectively. “This is a very important endpoint. These results are excellent,” he commented. “And there is really no appreciable difference between the two arms on the actuarial analysis.”
As far as specific treatment failure events in the trial overall, three patients died, eight underwent cystectomy, and eight developed distant metastases. Although numbers were small, these events appeared fairly evenly distributed across arms.
The rate of grade 3 or 4 acute toxicity was 57.6% with twice-daily radiation plus 5-flourouracil-cisplatin and 54.6% with daily radiation plus gemcitabine. The large majority of events were blood and bone marrow toxicity. “It’s quite notable that the rates of GU and GI toxicity were very low,” commented Dr. Coen, who disclosed that he had no relevant conflicts of interest.
SOURCE: Coen, J. et al, 2018 Genitourinary Cancers Symposium, Abstract 408
SAN FRANCISCO – Two concurrent chemoradiation induction regimens had similar safety and efficacy when used as part of a bladder-sparing strategy in patients with muscle-invasive bladder cancer, suggest primary results of the NRG/RTOG 0712 trial. But one offers better patient convenience.
The selective bladder-preservation paradigm entails maximal transurethral resection of the bladder tumor (TURBT) followed by induction radiation and concomitant chemotherapy, lead author John J. Coen, MD, a radiation oncologist with 21st Century Oncology, Providence, Rhode Island, noted at the 2018 Genitourinary Cancers Symposium. Patients then undergo cystoscopy to assess their response.
“A key component of this therapy is close urologic surveillance,” he noted. “This is trimodality therapy with close urologic surveillance, and cystectomy is prompted at the earliest time it’s indicated.”
The 70 patients enrolled in the multicenter randomized phase 2 trial had undergone TURBT and were randomized evenly to twice-daily radiation plus 5-flourouracil-cisplatin (the RTOG standard at the time of trial planning) or to daily radiation plus gemcitabine (a modification of a successful regimen developed at the University of Michigan). All were offered adjuvant chemotherapy regardless of whether they responded and whether they underwent consolidation therapy or cystectomy.
At a median follow-up of 5.1 years among the 52 evaluable patients, the 3-year rate of freedom from distant metastasis, the trial’s primary endpoint, was 78% with twice-daily radiation plus 5-flourouracil-cisplatin and 84% with daily radiation plus gemcitabine, according to results reported at the symposium, which was sponsored by the American Society of Clinical Oncology, ASTRO, and the Society of Urologic Oncology.
Both values were higher than the trial’s predefined benchmark of 75% for defining the regimen as promising. “This trial wasn’t necessarily powered to compare arms, so the conclusion would be that both arms exceeded the benchmark and it would be appropriate to evaluate both arms further in subsequent trials,” Dr. Coen commented.
In each trial arm, more than three-fourths of patients had a complete response, and about two-thirds of patients were alive and free of distant metastasis with their bladder intact at 3 years.
Toxicity, which was supposed to be the tie-breaker if efficacy was similar, was also essentially the same for the two regimens. Both were fairly well tolerated in the acute period; the primary grade 3 and 4 toxicities were hematologic ones.
“So where do we go from here? I think this trial does demonstrate concurrent gemcitabine is a reasonable alternative to cisplatin for patients undergoing selective bladder preservation,” Dr. Coen summarized. “This is especially important in patients with poor renal function or hearing loss. And bladder cancer is often a disease in the elderly, so tolerance of various regimens is a very important aspect to planning further trials.”
“This trial also demonstrates that daily radiation is a reasonable alternative to twice-a-day radiation, which had become the standard through the RTOG on more contemporary trials,” he added. “Daily radiation would allow wider adoption of selective bladder preservation by trimodality therapy.”
Clinical implications
“I would have to see more details about the toxicity data for the chemotherapy, the radiosensitizers,” session co-chair Yair Lotan, MD, a professor of urology at the UT Southwestern Medical Center, Dallas, Texas, commented in an interview. “But in general, if you have two equivalent protocols in terms of effectiveness, and one is less toxic or more convenient, that’s always preferable. From the standpoint of coming once a day rather than twice a day to get radiation, if I were a patient, I would prefer that regimen”
Current practice in this patient population likely hinges on where a patient is treated, he said. “Based on the new nonmetastatic muscle-invasive guidelines, many of them would be recommended surgery or possibly chemoradiation protocols, and then there are a lot of factors such as patient preference and outcomes that would probably impact the decision making.”
“Certainly, this study won’t prove standard of care because standard of care in the global picture for a patient with muscle-invasive disease really will depend on a randomized trial of surgery versus radiation or chemoradiation, multimodal therapies,” Dr. Lotan maintained. “Not every patient is even eligible; some patients with hydronephrosis or unresectable disease may not be the best candidates for multimodal therapy. But more information from these types of trials may help clinicians decide which multimodal therapy approach to use.”
Study details
Patients enrolled in NRG/RTOG 0712, a multicenter randomized phase 2 trial supported by the National Cancer Institute, had clinical T2 or T3-4a bladder cancer. Hydronephrosis and obvious lymph node involvement were exclusion criteria.
Like the rate of freedom from metastasis, the rate of complete response after induction therapy was similar for the two arms: 87.9% with twice-daily radiation plus 5-flourouracil-cisplatin and 75.8% with daily radiation plus gemcitabine.
“These rates exceed historical complete response rates, and this is likely a result of improved selection over time and more thorough TURBTs performed over time,” Dr. Coen proposed. “Over the course of multiple successive RTOG trials, our selection criteria have been refined. One excellent example would be that hydronephrosis has been excluded on more contemporary trials, but if you look at older trials, those patients were included.”
The 3-year rate of bladder-intact distant metastasis–free survival was 66.7% and 69%, respectively. “This is a very important endpoint. These results are excellent,” he commented. “And there is really no appreciable difference between the two arms on the actuarial analysis.”
As far as specific treatment failure events in the trial overall, three patients died, eight underwent cystectomy, and eight developed distant metastases. Although numbers were small, these events appeared fairly evenly distributed across arms.
The rate of grade 3 or 4 acute toxicity was 57.6% with twice-daily radiation plus 5-flourouracil-cisplatin and 54.6% with daily radiation plus gemcitabine. The large majority of events were blood and bone marrow toxicity. “It’s quite notable that the rates of GU and GI toxicity were very low,” commented Dr. Coen, who disclosed that he had no relevant conflicts of interest.
SOURCE: Coen, J. et al, 2018 Genitourinary Cancers Symposium, Abstract 408
AT THE GENITOURINARY CANCERS SYMPOSIUM
Key clinical point:
Major finding: The rate of freedom from distant metastasis at 3 years was 77.8% with twice-daily radiation plus 5-flourouracil-cisplatin and 84.0% with daily radiation plus gemcitabine.
Data source: A multicenter randomized phase 2 trial among 70 patients with muscle-invasive (cT2-4a) bladder cancer who had undergone TURBT (NRG/RTOG 0712 trial).
Disclosures: Dr. Coen disclosed that he had no relevant conflicts of interest. The trial was supported by the National Cancer Institute.
Source: Coen, J. et al, 2018 Genitourinary Cancers Symposium, Abstract 408.
Minority of dermatologists prescribe majority of opioids
Opioid prescribing among dermatologists is concentrated among a relative few, with surgeons and those in Southern states overrepresented, according to a study of Medicare Part D data for 2014.
“A small number of dermatologists account for a large percentage of the prescriptions. And it’s concentrated among dermatology surgeons, who are likely giving a standard prescription for a 4-day course of opioids after surgery,” senior author Arash Mostaghimi, MD, the director of inpatient services in the dermatology department at Brigham and Women’s Hospital, Boston, said in a press release issued by the hospital.
A closer look at those 115 top prescribers shows that 108, or 94%, worked in a surgical practice, 72% were located in Southern states, and 86% were male. Among all the dermatologists in the study, those in the South also had an opioid prescribing rate (2.77 claims/1,000 Medicare beneficiaries) that was more than triple the rate in the Northeast (0.83 claims/1,000 beneficiaries), the investigators said.
they noted, and may have created, based on consumption habits after Mohs microsurgery, a reservoir of more than 490,000 unused pills “that poses a substantial risk for future misuse.”
The study was supported by the National Institutes of Health’s National Center for Advancing Translational Sciences. The investigators did not report any conflicts of interest.
SOURCE: Cao S et al. JAMA Dermatol. 2018 Feb 7. doi: 10.1001/jamadermatol.2017.5835.
Opioid prescribing among dermatologists is concentrated among a relative few, with surgeons and those in Southern states overrepresented, according to a study of Medicare Part D data for 2014.
“A small number of dermatologists account for a large percentage of the prescriptions. And it’s concentrated among dermatology surgeons, who are likely giving a standard prescription for a 4-day course of opioids after surgery,” senior author Arash Mostaghimi, MD, the director of inpatient services in the dermatology department at Brigham and Women’s Hospital, Boston, said in a press release issued by the hospital.
A closer look at those 115 top prescribers shows that 108, or 94%, worked in a surgical practice, 72% were located in Southern states, and 86% were male. Among all the dermatologists in the study, those in the South also had an opioid prescribing rate (2.77 claims/1,000 Medicare beneficiaries) that was more than triple the rate in the Northeast (0.83 claims/1,000 beneficiaries), the investigators said.
they noted, and may have created, based on consumption habits after Mohs microsurgery, a reservoir of more than 490,000 unused pills “that poses a substantial risk for future misuse.”
The study was supported by the National Institutes of Health’s National Center for Advancing Translational Sciences. The investigators did not report any conflicts of interest.
SOURCE: Cao S et al. JAMA Dermatol. 2018 Feb 7. doi: 10.1001/jamadermatol.2017.5835.
Opioid prescribing among dermatologists is concentrated among a relative few, with surgeons and those in Southern states overrepresented, according to a study of Medicare Part D data for 2014.
“A small number of dermatologists account for a large percentage of the prescriptions. And it’s concentrated among dermatology surgeons, who are likely giving a standard prescription for a 4-day course of opioids after surgery,” senior author Arash Mostaghimi, MD, the director of inpatient services in the dermatology department at Brigham and Women’s Hospital, Boston, said in a press release issued by the hospital.
A closer look at those 115 top prescribers shows that 108, or 94%, worked in a surgical practice, 72% were located in Southern states, and 86% were male. Among all the dermatologists in the study, those in the South also had an opioid prescribing rate (2.77 claims/1,000 Medicare beneficiaries) that was more than triple the rate in the Northeast (0.83 claims/1,000 beneficiaries), the investigators said.
they noted, and may have created, based on consumption habits after Mohs microsurgery, a reservoir of more than 490,000 unused pills “that poses a substantial risk for future misuse.”
The study was supported by the National Institutes of Health’s National Center for Advancing Translational Sciences. The investigators did not report any conflicts of interest.
SOURCE: Cao S et al. JAMA Dermatol. 2018 Feb 7. doi: 10.1001/jamadermatol.2017.5835.
FROM JAMA DERMATOLOGY
ERV expression may predict response to immune checkpoint blockade in ccRCC, other solid tumors
SAN FRANCISCO – The (ccRCC), according to findings from an analysis of nearly 5,000 tumor samples.
Similar associations may exist in other solid tumors, Shridar Ganesan, MD, reported at the ASCO-SITC Clinical Immuno-Oncology Symposium.
Merkel cell carcinoma, for example, has a high response rate despite its relatively low mutation burden. This is explained by the presence of infection with the Merkel cell polyomavirus in a low mutation burden subset, he said, noting that expression of the virus likely leads to expression of antigens that makes the disease both highly immunogenic and responsive to immune checkpoint therapy.
Expression of exogenous viruses is associated with response to immune checkpoint therapy in other cancers with low mutation burden, such as Epstein-Barr virus-positive gastric cancer, natural killer lymphoma, and Hodgkin disease.
“Intriguingly, renal cell carcinoma also has a relatively higher response rate to immune checkpoint therapy than would be anticipated by its relatively low mutation burden. However, this has no evidence of exogenous virus infection. Therefore, we turned our attention to endogenous retroviruses, which are an abundant potential stimulant of innate immunity in cancer,” he said.
Endogenous retroviruses (ERVs) now comprise about 5-8% of the human genome, and almost all of them have mutations that disable key coding genes of the retrovirus, meaning most cannot produce all the proteins necessary for viral replication.
“They’re essentially genomic fossils,” Dr. Ganesan said, adding that they all are silenced epigenetically in most normal adult tissues, both by DNA methylation and histone methylation. “However, inappropriate expression of endogenous retroviruses has been reported by multiple groups in some cancers and has been associated with evidence of immune activation. One can imagine that endogenous retroviral expression can be immunogenic both by expression of some [open reading frames] that are not disabled ... or just the viral RNA itself, which can be detected by cytoplasmic sensors ... and activate innate immunity,” he said.
To assess whether ERV expression corresponds with evidence of immune checkpoint activation in cancer, he and his colleagues conducted a pan-cancer analysis of more than 4,900 tumors across 21 cancer types using data from the Cancer Genome Atlas (TCGA).
“When we did this for about 66 annotated endogenous retroviruses in the TCGA database, we could see that different cancers had different amounts of retrovirus associated with immune activation ... in fact the strongest signal seen in this analysis was in clear cell renal cell carcinoma,” he said.
Signals were also seen in estrogen receptor–positive/human epidermal growth factor receptor 2-negative breast cancer, head and neck squamous cell carcinoma, and colon cancer.
A variety of ERVs were upregulated in RCC; different panels were associated with different cancer types. But two – ERVK.2 and ERV3.2 – were consistently upregulated across all the tumor types.
A closer look at ERV expression showed three clear clusters: extremely-high, intermediate, and low expression of ERV, and the very-high expression cluster had increased expression of numerous checkpoint genes, including CD8A, PD1, CTLA4, and LAG3 among others, compared with the low expression cluster.
This leads to the question of why a subset of RCCs have ERV expression.
In an attempt to answer that question, a transcript analysis was conducted to determine which transcripts are differentially regulated between the high and low ERV-expressing groups, and gene ontology analysis was performed.
“The results were quite striking. If you look at the modules that are differentially expressed between the high-ERV and the low-ERV groups, what pops up is really a lot of histone methyltransferase modules and chromatin regulation modules, ” he said, noting that this makes sense because of the silencing of ERV expression by histone methylation and DNA methylation, and suggests that “there is some deep abnormality in chromatin modulation in this subset of RCCs.
“This is intriguing, because RCCs are known to have mutations in chromatin modifying genes,” he said.
A look into whether the high-ERV–expressing group was enriched in any of these mutations showed some enrichment of BAP1 in the high- vs. low-expressing group, and that is currently being looked at further, he noted.
The next question was whether ERV expression correlated with response to immune checkpoint blockade in ccRCC, and this was looked at in a nonrandomized group of 15 patients with metastatic ccRCC who were treated with single-agent immune checkpoint therapy who had either clearly documented partial response or progressive disease. In 13 patient samples for which RNA expression of ERV3.2 was successfully measured by quantitative real-time polymerase chain reaction using two primer sets, ERV3.2 expression was significantly higher in responders vs. nonresponders in both primer sets (P less than .05 and .005).
“In summary, we have shown that expression of ERVs correlates with immune activation and increased expression of immune checkpoint genes in a subset of ccRCC, and perhaps several other solid tumor classes, and the expression of ERV3.2 is perhaps associated with response to PD1 blockade in this small preliminary cohort of ccRCC patients,” he said, noting that abnormal expression of ERV may be a biomarker of immune checkpoint therapy response in some cancers with a low mutation burden. “Mechanisms underlying ERV expression need to be investigated and may reflect underlying chromatin alterations or epigenetic abnormalities.”
Dr. Ganesan reported that his spouse is employed by Merck and that he is a consultant and/or advisory board member for Novartis, Roche, and Inspirata. He also holds patents with Inspirata.
sworcester@frontlinemedcom.com
SOURCE: Panda A et al., ASCO-SITC, Abstract #104.
SAN FRANCISCO – The (ccRCC), according to findings from an analysis of nearly 5,000 tumor samples.
Similar associations may exist in other solid tumors, Shridar Ganesan, MD, reported at the ASCO-SITC Clinical Immuno-Oncology Symposium.
Merkel cell carcinoma, for example, has a high response rate despite its relatively low mutation burden. This is explained by the presence of infection with the Merkel cell polyomavirus in a low mutation burden subset, he said, noting that expression of the virus likely leads to expression of antigens that makes the disease both highly immunogenic and responsive to immune checkpoint therapy.
Expression of exogenous viruses is associated with response to immune checkpoint therapy in other cancers with low mutation burden, such as Epstein-Barr virus-positive gastric cancer, natural killer lymphoma, and Hodgkin disease.
“Intriguingly, renal cell carcinoma also has a relatively higher response rate to immune checkpoint therapy than would be anticipated by its relatively low mutation burden. However, this has no evidence of exogenous virus infection. Therefore, we turned our attention to endogenous retroviruses, which are an abundant potential stimulant of innate immunity in cancer,” he said.
Endogenous retroviruses (ERVs) now comprise about 5-8% of the human genome, and almost all of them have mutations that disable key coding genes of the retrovirus, meaning most cannot produce all the proteins necessary for viral replication.
“They’re essentially genomic fossils,” Dr. Ganesan said, adding that they all are silenced epigenetically in most normal adult tissues, both by DNA methylation and histone methylation. “However, inappropriate expression of endogenous retroviruses has been reported by multiple groups in some cancers and has been associated with evidence of immune activation. One can imagine that endogenous retroviral expression can be immunogenic both by expression of some [open reading frames] that are not disabled ... or just the viral RNA itself, which can be detected by cytoplasmic sensors ... and activate innate immunity,” he said.
To assess whether ERV expression corresponds with evidence of immune checkpoint activation in cancer, he and his colleagues conducted a pan-cancer analysis of more than 4,900 tumors across 21 cancer types using data from the Cancer Genome Atlas (TCGA).
“When we did this for about 66 annotated endogenous retroviruses in the TCGA database, we could see that different cancers had different amounts of retrovirus associated with immune activation ... in fact the strongest signal seen in this analysis was in clear cell renal cell carcinoma,” he said.
Signals were also seen in estrogen receptor–positive/human epidermal growth factor receptor 2-negative breast cancer, head and neck squamous cell carcinoma, and colon cancer.
A variety of ERVs were upregulated in RCC; different panels were associated with different cancer types. But two – ERVK.2 and ERV3.2 – were consistently upregulated across all the tumor types.
A closer look at ERV expression showed three clear clusters: extremely-high, intermediate, and low expression of ERV, and the very-high expression cluster had increased expression of numerous checkpoint genes, including CD8A, PD1, CTLA4, and LAG3 among others, compared with the low expression cluster.
This leads to the question of why a subset of RCCs have ERV expression.
In an attempt to answer that question, a transcript analysis was conducted to determine which transcripts are differentially regulated between the high and low ERV-expressing groups, and gene ontology analysis was performed.
“The results were quite striking. If you look at the modules that are differentially expressed between the high-ERV and the low-ERV groups, what pops up is really a lot of histone methyltransferase modules and chromatin regulation modules, ” he said, noting that this makes sense because of the silencing of ERV expression by histone methylation and DNA methylation, and suggests that “there is some deep abnormality in chromatin modulation in this subset of RCCs.
“This is intriguing, because RCCs are known to have mutations in chromatin modifying genes,” he said.
A look into whether the high-ERV–expressing group was enriched in any of these mutations showed some enrichment of BAP1 in the high- vs. low-expressing group, and that is currently being looked at further, he noted.
The next question was whether ERV expression correlated with response to immune checkpoint blockade in ccRCC, and this was looked at in a nonrandomized group of 15 patients with metastatic ccRCC who were treated with single-agent immune checkpoint therapy who had either clearly documented partial response or progressive disease. In 13 patient samples for which RNA expression of ERV3.2 was successfully measured by quantitative real-time polymerase chain reaction using two primer sets, ERV3.2 expression was significantly higher in responders vs. nonresponders in both primer sets (P less than .05 and .005).
“In summary, we have shown that expression of ERVs correlates with immune activation and increased expression of immune checkpoint genes in a subset of ccRCC, and perhaps several other solid tumor classes, and the expression of ERV3.2 is perhaps associated with response to PD1 blockade in this small preliminary cohort of ccRCC patients,” he said, noting that abnormal expression of ERV may be a biomarker of immune checkpoint therapy response in some cancers with a low mutation burden. “Mechanisms underlying ERV expression need to be investigated and may reflect underlying chromatin alterations or epigenetic abnormalities.”
Dr. Ganesan reported that his spouse is employed by Merck and that he is a consultant and/or advisory board member for Novartis, Roche, and Inspirata. He also holds patents with Inspirata.
sworcester@frontlinemedcom.com
SOURCE: Panda A et al., ASCO-SITC, Abstract #104.
SAN FRANCISCO – The (ccRCC), according to findings from an analysis of nearly 5,000 tumor samples.
Similar associations may exist in other solid tumors, Shridar Ganesan, MD, reported at the ASCO-SITC Clinical Immuno-Oncology Symposium.
Merkel cell carcinoma, for example, has a high response rate despite its relatively low mutation burden. This is explained by the presence of infection with the Merkel cell polyomavirus in a low mutation burden subset, he said, noting that expression of the virus likely leads to expression of antigens that makes the disease both highly immunogenic and responsive to immune checkpoint therapy.
Expression of exogenous viruses is associated with response to immune checkpoint therapy in other cancers with low mutation burden, such as Epstein-Barr virus-positive gastric cancer, natural killer lymphoma, and Hodgkin disease.
“Intriguingly, renal cell carcinoma also has a relatively higher response rate to immune checkpoint therapy than would be anticipated by its relatively low mutation burden. However, this has no evidence of exogenous virus infection. Therefore, we turned our attention to endogenous retroviruses, which are an abundant potential stimulant of innate immunity in cancer,” he said.
Endogenous retroviruses (ERVs) now comprise about 5-8% of the human genome, and almost all of them have mutations that disable key coding genes of the retrovirus, meaning most cannot produce all the proteins necessary for viral replication.
“They’re essentially genomic fossils,” Dr. Ganesan said, adding that they all are silenced epigenetically in most normal adult tissues, both by DNA methylation and histone methylation. “However, inappropriate expression of endogenous retroviruses has been reported by multiple groups in some cancers and has been associated with evidence of immune activation. One can imagine that endogenous retroviral expression can be immunogenic both by expression of some [open reading frames] that are not disabled ... or just the viral RNA itself, which can be detected by cytoplasmic sensors ... and activate innate immunity,” he said.
To assess whether ERV expression corresponds with evidence of immune checkpoint activation in cancer, he and his colleagues conducted a pan-cancer analysis of more than 4,900 tumors across 21 cancer types using data from the Cancer Genome Atlas (TCGA).
“When we did this for about 66 annotated endogenous retroviruses in the TCGA database, we could see that different cancers had different amounts of retrovirus associated with immune activation ... in fact the strongest signal seen in this analysis was in clear cell renal cell carcinoma,” he said.
Signals were also seen in estrogen receptor–positive/human epidermal growth factor receptor 2-negative breast cancer, head and neck squamous cell carcinoma, and colon cancer.
A variety of ERVs were upregulated in RCC; different panels were associated with different cancer types. But two – ERVK.2 and ERV3.2 – were consistently upregulated across all the tumor types.
A closer look at ERV expression showed three clear clusters: extremely-high, intermediate, and low expression of ERV, and the very-high expression cluster had increased expression of numerous checkpoint genes, including CD8A, PD1, CTLA4, and LAG3 among others, compared with the low expression cluster.
This leads to the question of why a subset of RCCs have ERV expression.
In an attempt to answer that question, a transcript analysis was conducted to determine which transcripts are differentially regulated between the high and low ERV-expressing groups, and gene ontology analysis was performed.
“The results were quite striking. If you look at the modules that are differentially expressed between the high-ERV and the low-ERV groups, what pops up is really a lot of histone methyltransferase modules and chromatin regulation modules, ” he said, noting that this makes sense because of the silencing of ERV expression by histone methylation and DNA methylation, and suggests that “there is some deep abnormality in chromatin modulation in this subset of RCCs.
“This is intriguing, because RCCs are known to have mutations in chromatin modifying genes,” he said.
A look into whether the high-ERV–expressing group was enriched in any of these mutations showed some enrichment of BAP1 in the high- vs. low-expressing group, and that is currently being looked at further, he noted.
The next question was whether ERV expression correlated with response to immune checkpoint blockade in ccRCC, and this was looked at in a nonrandomized group of 15 patients with metastatic ccRCC who were treated with single-agent immune checkpoint therapy who had either clearly documented partial response or progressive disease. In 13 patient samples for which RNA expression of ERV3.2 was successfully measured by quantitative real-time polymerase chain reaction using two primer sets, ERV3.2 expression was significantly higher in responders vs. nonresponders in both primer sets (P less than .05 and .005).
“In summary, we have shown that expression of ERVs correlates with immune activation and increased expression of immune checkpoint genes in a subset of ccRCC, and perhaps several other solid tumor classes, and the expression of ERV3.2 is perhaps associated with response to PD1 blockade in this small preliminary cohort of ccRCC patients,” he said, noting that abnormal expression of ERV may be a biomarker of immune checkpoint therapy response in some cancers with a low mutation burden. “Mechanisms underlying ERV expression need to be investigated and may reflect underlying chromatin alterations or epigenetic abnormalities.”
Dr. Ganesan reported that his spouse is employed by Merck and that he is a consultant and/or advisory board member for Novartis, Roche, and Inspirata. He also holds patents with Inspirata.
sworcester@frontlinemedcom.com
SOURCE: Panda A et al., ASCO-SITC, Abstract #104.
REPORTING FROM THE CLINICAL IMMUNO-ONCOLOGY SYMPOSIUM
Key clinical point: ERV3.2 expression is associated with immune checkpoint blockade response in ccRCC.
Major finding: ERV3.2 expression was significantly higher in responders vs. nonresponders in two primer sets (P less than .05 and.005).
Study details: A pan-cancer analysis of more 4,900 tumors.
Disclosures: Dr. Ganesan reported that his spouse is employed by Merck and that he is a consultant and/or advisory board member for Novartis, Roche, and Inspirata. He also holds patents with Inspirata
Source: Panda A et al. ASCO-SITC, Abstract #104.
Prenatal betamethasone could save millions in care costs for women at risk of late preterm delivery
DALLAS – If betamethasone became a routine part of managing women at risk for late preterm birth, the U.S. health care system could save up to $200 million in direct costs every year.
A significant decrease in the cost of managing newborn respiratory morbidity would account for most of the savings, Cynthia Gyamfi-Bannerman, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Not only was betamethasone treatment cost effective at its base price, but treatment retained economic dominance over no treatment even when its cost was inflated up to 500%.
She presented a cost analysis of the 2016 PARENT trial. PARENT randomized 2,831 women at risk of late preterm delivery to two injections of betamethasone or matching placebo 24 hours apart. Infants exposed to betamethasone were 20% less likely to experience the primary endpoint – a composite of the need for continuous positive airway pressure or high-flow nasal cannula, supplemental oxygen, extracorporeal membrane oxygenation, or mechanical ventilation. They were also significantly less likely to be stillborn or to die within 72 hours of delivery.
“We found that antenatal betamethasone significantly decreased perinatal morbidity and mortality,” she said. “However, the costs of this intervention were unknown. Therefore, we compared the cost-effectiveness of treatment with no treatment in these women.”
Dr. Gyamfi-Bannerman described the study as a cost-minimization analysis. “The analysis took a third-party payer approach with a time horizon to first hospital discharge to home.”
Maternal costs were based on Medicaid rates. These included the cost of the betamethasone, and any out- or inpatient visits necessary to administer the drug. The neonatal costs included all direct medical costs for the newborn, including neonatal ICU admissions and any respiratory therapy the infant required.
The analysis included all mother-infant pairs in PARENT who had at least one dose of their assigned study drug and full follow-up. This comprised 1,425 pairs who received betamethasone and 1,396 who received placebo. The total mean cost of maternal/newborn care in the betamethasone group was $4,774, compared with $5,473 in the placebo group – a significant difference.
The cost-effectiveness analysis, with effectiveness defined as the proportion not reaching the primary outcome, significantly favored betamethasone as well (88.4% vs. 85.5%).
Dr. Gyamfi-Bannerman also examined cost-effectiveness in a variety of pricing scenarios, from looking at betamethasone at its base cost with hospital and physician services priced at 50% of the current level, to betamethasone inflated by 500% and other costs by 200%.
“In almost every estimate, betamethasone remained the cost-effective management option,” she said. “ and was cost effective across most of our variable estimate.”
She had no financial disclosures.
SOURCE: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
DALLAS – If betamethasone became a routine part of managing women at risk for late preterm birth, the U.S. health care system could save up to $200 million in direct costs every year.
A significant decrease in the cost of managing newborn respiratory morbidity would account for most of the savings, Cynthia Gyamfi-Bannerman, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Not only was betamethasone treatment cost effective at its base price, but treatment retained economic dominance over no treatment even when its cost was inflated up to 500%.
She presented a cost analysis of the 2016 PARENT trial. PARENT randomized 2,831 women at risk of late preterm delivery to two injections of betamethasone or matching placebo 24 hours apart. Infants exposed to betamethasone were 20% less likely to experience the primary endpoint – a composite of the need for continuous positive airway pressure or high-flow nasal cannula, supplemental oxygen, extracorporeal membrane oxygenation, or mechanical ventilation. They were also significantly less likely to be stillborn or to die within 72 hours of delivery.
“We found that antenatal betamethasone significantly decreased perinatal morbidity and mortality,” she said. “However, the costs of this intervention were unknown. Therefore, we compared the cost-effectiveness of treatment with no treatment in these women.”
Dr. Gyamfi-Bannerman described the study as a cost-minimization analysis. “The analysis took a third-party payer approach with a time horizon to first hospital discharge to home.”
Maternal costs were based on Medicaid rates. These included the cost of the betamethasone, and any out- or inpatient visits necessary to administer the drug. The neonatal costs included all direct medical costs for the newborn, including neonatal ICU admissions and any respiratory therapy the infant required.
The analysis included all mother-infant pairs in PARENT who had at least one dose of their assigned study drug and full follow-up. This comprised 1,425 pairs who received betamethasone and 1,396 who received placebo. The total mean cost of maternal/newborn care in the betamethasone group was $4,774, compared with $5,473 in the placebo group – a significant difference.
The cost-effectiveness analysis, with effectiveness defined as the proportion not reaching the primary outcome, significantly favored betamethasone as well (88.4% vs. 85.5%).
Dr. Gyamfi-Bannerman also examined cost-effectiveness in a variety of pricing scenarios, from looking at betamethasone at its base cost with hospital and physician services priced at 50% of the current level, to betamethasone inflated by 500% and other costs by 200%.
“In almost every estimate, betamethasone remained the cost-effective management option,” she said. “ and was cost effective across most of our variable estimate.”
She had no financial disclosures.
SOURCE: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
DALLAS – If betamethasone became a routine part of managing women at risk for late preterm birth, the U.S. health care system could save up to $200 million in direct costs every year.
A significant decrease in the cost of managing newborn respiratory morbidity would account for most of the savings, Cynthia Gyamfi-Bannerman, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Not only was betamethasone treatment cost effective at its base price, but treatment retained economic dominance over no treatment even when its cost was inflated up to 500%.
She presented a cost analysis of the 2016 PARENT trial. PARENT randomized 2,831 women at risk of late preterm delivery to two injections of betamethasone or matching placebo 24 hours apart. Infants exposed to betamethasone were 20% less likely to experience the primary endpoint – a composite of the need for continuous positive airway pressure or high-flow nasal cannula, supplemental oxygen, extracorporeal membrane oxygenation, or mechanical ventilation. They were also significantly less likely to be stillborn or to die within 72 hours of delivery.
“We found that antenatal betamethasone significantly decreased perinatal morbidity and mortality,” she said. “However, the costs of this intervention were unknown. Therefore, we compared the cost-effectiveness of treatment with no treatment in these women.”
Dr. Gyamfi-Bannerman described the study as a cost-minimization analysis. “The analysis took a third-party payer approach with a time horizon to first hospital discharge to home.”
Maternal costs were based on Medicaid rates. These included the cost of the betamethasone, and any out- or inpatient visits necessary to administer the drug. The neonatal costs included all direct medical costs for the newborn, including neonatal ICU admissions and any respiratory therapy the infant required.
The analysis included all mother-infant pairs in PARENT who had at least one dose of their assigned study drug and full follow-up. This comprised 1,425 pairs who received betamethasone and 1,396 who received placebo. The total mean cost of maternal/newborn care in the betamethasone group was $4,774, compared with $5,473 in the placebo group – a significant difference.
The cost-effectiveness analysis, with effectiveness defined as the proportion not reaching the primary outcome, significantly favored betamethasone as well (88.4% vs. 85.5%).
Dr. Gyamfi-Bannerman also examined cost-effectiveness in a variety of pricing scenarios, from looking at betamethasone at its base cost with hospital and physician services priced at 50% of the current level, to betamethasone inflated by 500% and other costs by 200%.
“In almost every estimate, betamethasone remained the cost-effective management option,” she said. “ and was cost effective across most of our variable estimate.”
She had no financial disclosures.
SOURCE: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: If widely adopted, prenatal betamethasone could save up to $200 million per year by preventing neonatal respiratory morbidity.
Major finding: The total mean maternal/newborn care cost was $4,774 in the betamethasone group and $5,473 in the placebo group.
Study details: The cost analysis of the PARENT trial comprised 2,821 mother/infant pairs.
Disclosures: Dr. Gyamfi-Bannerman had no financial disclosures.
Source: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
Hypertension Risk Found in Women with Migraine
Women with migraine have a higher relative risk of developing hypertension compared to women without migraine, according to a recent study. Researchers performed a prospective cohort study among 29,040 women without hypertension at baseline. Women were classified as having active migraine with aura, active migraine without aura, a past history of migraine, or no history of migraine. Incident hypertension was defined as new physician diagnosis or newly self-reported systolic or diastolic blood pressure ≥140 mmHg or ≥90 mmHg, respectively. They found:
- During a mean follow-up of 12.2 years, 15,176 incident hypertension cases occurred.
- Compared to those with no history of migraine, women who experience migraine with aura had a 9% increase in their risk of developing hypertension; women who experience migraine without aura had a 21% increase in their risk of developing hypertension; and women with a past history of migraine had a 15% increase in their risk of developing hypertension.
Migraine and the risk of incident hypertension among women. [Published online ahead of print February 1, 2018]. Cephalalgia. doi:10.1177/0333102418756865.
Women with migraine have a higher relative risk of developing hypertension compared to women without migraine, according to a recent study. Researchers performed a prospective cohort study among 29,040 women without hypertension at baseline. Women were classified as having active migraine with aura, active migraine without aura, a past history of migraine, or no history of migraine. Incident hypertension was defined as new physician diagnosis or newly self-reported systolic or diastolic blood pressure ≥140 mmHg or ≥90 mmHg, respectively. They found:
- During a mean follow-up of 12.2 years, 15,176 incident hypertension cases occurred.
- Compared to those with no history of migraine, women who experience migraine with aura had a 9% increase in their risk of developing hypertension; women who experience migraine without aura had a 21% increase in their risk of developing hypertension; and women with a past history of migraine had a 15% increase in their risk of developing hypertension.
Migraine and the risk of incident hypertension among women. [Published online ahead of print February 1, 2018]. Cephalalgia. doi:10.1177/0333102418756865.
Women with migraine have a higher relative risk of developing hypertension compared to women without migraine, according to a recent study. Researchers performed a prospective cohort study among 29,040 women without hypertension at baseline. Women were classified as having active migraine with aura, active migraine without aura, a past history of migraine, or no history of migraine. Incident hypertension was defined as new physician diagnosis or newly self-reported systolic or diastolic blood pressure ≥140 mmHg or ≥90 mmHg, respectively. They found:
- During a mean follow-up of 12.2 years, 15,176 incident hypertension cases occurred.
- Compared to those with no history of migraine, women who experience migraine with aura had a 9% increase in their risk of developing hypertension; women who experience migraine without aura had a 21% increase in their risk of developing hypertension; and women with a past history of migraine had a 15% increase in their risk of developing hypertension.
Migraine and the risk of incident hypertension among women. [Published online ahead of print February 1, 2018]. Cephalalgia. doi:10.1177/0333102418756865.
Promising outcomes of thrombolysis for caval extension of iliofemoral DVT
CHICAGO – Caval extension of an acute iliofemoral deep vein thrombosis paradoxically portends better treatment outcomes than does thrombolysis of a DVT without involvement of the inferior vena cava, according to Rabih A. Chaer, MD, professor of surgery at the University of Pittsburgh.
This finding from a retrospective analysis of the University of Pittsburgh experience might seem counterintuitive. After all, caval extension clearly indicates a greater clot burden. One possible explanation: Clearing a thrombus from a large vessel, such as the inferior vena cava (IVC), provides an added protective effect. Also, since the caval segments don’t have valves – their flow is based upon negative pressure in the chest – they may not contribute as much to postthrombotic morbidity to the same extent as do thrombosed iliofemoral segments, Dr. Chaer speculated at a symposium on vascular surgery sponsored by Northwestern University.
The impetus for Dr. Chaer and coinvestigators to review the Pittsburgh experience was a lack of clarity in the literature as to the effect IVC thrombosis has on thrombolysis outcomes in patients with acute iliofemoral DVT. Even though caval thrombus extension is present in up to 22% of patients with iliofemoral DVT, current guidelines issued by the American College of Chest Physicians, the American Heart Association, and the Society for Vascular Surgery don’t address the distinction between iliofemoral DVT with and without IVC extension in regard to the occurrence of postthrombotic syndrome (PTS), the most common complication of DVT.
The incidence of PTS in patients whose iliofemoral DVT is treated by anticoagulation and compression alone is up to 50%. Mounting evidence indicates that catheter-directed thrombolysis and pharmacomechanical thrombolysis aimed at achieving early thrombus removal and symptom relief help maintain valvular competence and reduce the risk of PTS, the surgeon noted.
PTS is diagnosed using the validated Villalta scale, which incorporates clinical signs including pain on calf compression, skin edema and redness, and ulcers, as well as symptoms such as leg cramping, heaviness, itching, and paresthesia.
The Pittsburgh series included 102 consecutive patients treated with various combinations of catheter-directed or pharmacomechanical thrombolysis in 127 limbs with acute iliofemoral thrombosis. In 46 patients, the thrombus extended into the IVC, all the way up to the renal veins in most cases.
The groups with and without caval extension were similar in terms of age and prevalence of malignancy, hypercoagulable state, and clot age. However, a history of previous DVT was significantly more common in the group with IVC thrombus. Also, more than 60% of patients with caval extension got an IVC filter, a rate more than 10-fold greater than that in patients without caval extension.
In this series, caval thrombosis had no effect on the technical success of thrombolysis. The technical success rate –defined as at least 50% clot lysis – was 89% in both groups. Rates of recurrent DVT within 30 days were similar in the two groups as well: 11% in the caval thrombosis group and 14% in the noncaval group. At 2 years postintervention, 77%-78% of patients in both groups remained free of DVT recurrence. The rate of PTS – defined by a Villalta score of 5 or more – at 2 years was 34% in the noncaval group, which was significantly higher than the 11% rate in patients with IVC thrombus extension. Ultrasound-identified valve reflux was present in 51% of the noncaval group at 2 years, compared with 51% of the noncaval group.
On multivariate analysis, incomplete clot lysis was associated with nearly a 23-fold increased risk of recurrent DVT and a 5.6-fold increased risk of PTS. Caval involvement was independently associated with a 78% reduction in PTS risk.
The Society for Vascular Surgery’s guidelines recommend pharmacomechanical thrombolysis over catheter-directed thrombolysis if the expertise is available. The Pittsburgh experience speaks to the worth of that recommendation.
“Pharmacomechanical techniques can be advantageous. They can expedite the lysis process by clearing most of the clot. In our series, 20 patients were treated with pharmacomechanical techniques in a single session,” Dr. Chaer noted.
The use of IVC filters in the setting of caval extension of iliofemoral DVT is controversial, according to the surgeon: A thrombus that gets trapped in the filter is tough to remove, precluding successful recanalization.
“One-third of the patients in our series got a filter, but we’ve become more conservative nowadays. We don’t use filters anymore. But I think those patients who might benefit from an IVC filter are those who present with a PE [pulmonary embolism], because that’s telling you they might develop another PE, as well as those patients in whom pharmacomechanical thrombolysis is anticipated because we’ve seen that those patients are also more likely to develop a PE,” he said.
The University of Pittsburgh study on the effect of IVC thrombus extension has been published (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:385-91).
Dr. Chaer reported serving as a paid speaker for Boston Scientific.
SOURCE: Chaer RA. Northwestern Vascular Symposium 2017.
CHICAGO – Caval extension of an acute iliofemoral deep vein thrombosis paradoxically portends better treatment outcomes than does thrombolysis of a DVT without involvement of the inferior vena cava, according to Rabih A. Chaer, MD, professor of surgery at the University of Pittsburgh.
This finding from a retrospective analysis of the University of Pittsburgh experience might seem counterintuitive. After all, caval extension clearly indicates a greater clot burden. One possible explanation: Clearing a thrombus from a large vessel, such as the inferior vena cava (IVC), provides an added protective effect. Also, since the caval segments don’t have valves – their flow is based upon negative pressure in the chest – they may not contribute as much to postthrombotic morbidity to the same extent as do thrombosed iliofemoral segments, Dr. Chaer speculated at a symposium on vascular surgery sponsored by Northwestern University.
The impetus for Dr. Chaer and coinvestigators to review the Pittsburgh experience was a lack of clarity in the literature as to the effect IVC thrombosis has on thrombolysis outcomes in patients with acute iliofemoral DVT. Even though caval thrombus extension is present in up to 22% of patients with iliofemoral DVT, current guidelines issued by the American College of Chest Physicians, the American Heart Association, and the Society for Vascular Surgery don’t address the distinction between iliofemoral DVT with and without IVC extension in regard to the occurrence of postthrombotic syndrome (PTS), the most common complication of DVT.
The incidence of PTS in patients whose iliofemoral DVT is treated by anticoagulation and compression alone is up to 50%. Mounting evidence indicates that catheter-directed thrombolysis and pharmacomechanical thrombolysis aimed at achieving early thrombus removal and symptom relief help maintain valvular competence and reduce the risk of PTS, the surgeon noted.
PTS is diagnosed using the validated Villalta scale, which incorporates clinical signs including pain on calf compression, skin edema and redness, and ulcers, as well as symptoms such as leg cramping, heaviness, itching, and paresthesia.
The Pittsburgh series included 102 consecutive patients treated with various combinations of catheter-directed or pharmacomechanical thrombolysis in 127 limbs with acute iliofemoral thrombosis. In 46 patients, the thrombus extended into the IVC, all the way up to the renal veins in most cases.
The groups with and without caval extension were similar in terms of age and prevalence of malignancy, hypercoagulable state, and clot age. However, a history of previous DVT was significantly more common in the group with IVC thrombus. Also, more than 60% of patients with caval extension got an IVC filter, a rate more than 10-fold greater than that in patients without caval extension.
In this series, caval thrombosis had no effect on the technical success of thrombolysis. The technical success rate –defined as at least 50% clot lysis – was 89% in both groups. Rates of recurrent DVT within 30 days were similar in the two groups as well: 11% in the caval thrombosis group and 14% in the noncaval group. At 2 years postintervention, 77%-78% of patients in both groups remained free of DVT recurrence. The rate of PTS – defined by a Villalta score of 5 or more – at 2 years was 34% in the noncaval group, which was significantly higher than the 11% rate in patients with IVC thrombus extension. Ultrasound-identified valve reflux was present in 51% of the noncaval group at 2 years, compared with 51% of the noncaval group.
On multivariate analysis, incomplete clot lysis was associated with nearly a 23-fold increased risk of recurrent DVT and a 5.6-fold increased risk of PTS. Caval involvement was independently associated with a 78% reduction in PTS risk.
The Society for Vascular Surgery’s guidelines recommend pharmacomechanical thrombolysis over catheter-directed thrombolysis if the expertise is available. The Pittsburgh experience speaks to the worth of that recommendation.
“Pharmacomechanical techniques can be advantageous. They can expedite the lysis process by clearing most of the clot. In our series, 20 patients were treated with pharmacomechanical techniques in a single session,” Dr. Chaer noted.
The use of IVC filters in the setting of caval extension of iliofemoral DVT is controversial, according to the surgeon: A thrombus that gets trapped in the filter is tough to remove, precluding successful recanalization.
“One-third of the patients in our series got a filter, but we’ve become more conservative nowadays. We don’t use filters anymore. But I think those patients who might benefit from an IVC filter are those who present with a PE [pulmonary embolism], because that’s telling you they might develop another PE, as well as those patients in whom pharmacomechanical thrombolysis is anticipated because we’ve seen that those patients are also more likely to develop a PE,” he said.
The University of Pittsburgh study on the effect of IVC thrombus extension has been published (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:385-91).
Dr. Chaer reported serving as a paid speaker for Boston Scientific.
SOURCE: Chaer RA. Northwestern Vascular Symposium 2017.
CHICAGO – Caval extension of an acute iliofemoral deep vein thrombosis paradoxically portends better treatment outcomes than does thrombolysis of a DVT without involvement of the inferior vena cava, according to Rabih A. Chaer, MD, professor of surgery at the University of Pittsburgh.
This finding from a retrospective analysis of the University of Pittsburgh experience might seem counterintuitive. After all, caval extension clearly indicates a greater clot burden. One possible explanation: Clearing a thrombus from a large vessel, such as the inferior vena cava (IVC), provides an added protective effect. Also, since the caval segments don’t have valves – their flow is based upon negative pressure in the chest – they may not contribute as much to postthrombotic morbidity to the same extent as do thrombosed iliofemoral segments, Dr. Chaer speculated at a symposium on vascular surgery sponsored by Northwestern University.
The impetus for Dr. Chaer and coinvestigators to review the Pittsburgh experience was a lack of clarity in the literature as to the effect IVC thrombosis has on thrombolysis outcomes in patients with acute iliofemoral DVT. Even though caval thrombus extension is present in up to 22% of patients with iliofemoral DVT, current guidelines issued by the American College of Chest Physicians, the American Heart Association, and the Society for Vascular Surgery don’t address the distinction between iliofemoral DVT with and without IVC extension in regard to the occurrence of postthrombotic syndrome (PTS), the most common complication of DVT.
The incidence of PTS in patients whose iliofemoral DVT is treated by anticoagulation and compression alone is up to 50%. Mounting evidence indicates that catheter-directed thrombolysis and pharmacomechanical thrombolysis aimed at achieving early thrombus removal and symptom relief help maintain valvular competence and reduce the risk of PTS, the surgeon noted.
PTS is diagnosed using the validated Villalta scale, which incorporates clinical signs including pain on calf compression, skin edema and redness, and ulcers, as well as symptoms such as leg cramping, heaviness, itching, and paresthesia.
The Pittsburgh series included 102 consecutive patients treated with various combinations of catheter-directed or pharmacomechanical thrombolysis in 127 limbs with acute iliofemoral thrombosis. In 46 patients, the thrombus extended into the IVC, all the way up to the renal veins in most cases.
The groups with and without caval extension were similar in terms of age and prevalence of malignancy, hypercoagulable state, and clot age. However, a history of previous DVT was significantly more common in the group with IVC thrombus. Also, more than 60% of patients with caval extension got an IVC filter, a rate more than 10-fold greater than that in patients without caval extension.
In this series, caval thrombosis had no effect on the technical success of thrombolysis. The technical success rate –defined as at least 50% clot lysis – was 89% in both groups. Rates of recurrent DVT within 30 days were similar in the two groups as well: 11% in the caval thrombosis group and 14% in the noncaval group. At 2 years postintervention, 77%-78% of patients in both groups remained free of DVT recurrence. The rate of PTS – defined by a Villalta score of 5 or more – at 2 years was 34% in the noncaval group, which was significantly higher than the 11% rate in patients with IVC thrombus extension. Ultrasound-identified valve reflux was present in 51% of the noncaval group at 2 years, compared with 51% of the noncaval group.
On multivariate analysis, incomplete clot lysis was associated with nearly a 23-fold increased risk of recurrent DVT and a 5.6-fold increased risk of PTS. Caval involvement was independently associated with a 78% reduction in PTS risk.
The Society for Vascular Surgery’s guidelines recommend pharmacomechanical thrombolysis over catheter-directed thrombolysis if the expertise is available. The Pittsburgh experience speaks to the worth of that recommendation.
“Pharmacomechanical techniques can be advantageous. They can expedite the lysis process by clearing most of the clot. In our series, 20 patients were treated with pharmacomechanical techniques in a single session,” Dr. Chaer noted.
The use of IVC filters in the setting of caval extension of iliofemoral DVT is controversial, according to the surgeon: A thrombus that gets trapped in the filter is tough to remove, precluding successful recanalization.
“One-third of the patients in our series got a filter, but we’ve become more conservative nowadays. We don’t use filters anymore. But I think those patients who might benefit from an IVC filter are those who present with a PE [pulmonary embolism], because that’s telling you they might develop another PE, as well as those patients in whom pharmacomechanical thrombolysis is anticipated because we’ve seen that those patients are also more likely to develop a PE,” he said.
The University of Pittsburgh study on the effect of IVC thrombus extension has been published (J Vasc Surg Venous Lymphat Disord. 2016 Oct;4[4]:385-91).
Dr. Chaer reported serving as a paid speaker for Boston Scientific.
SOURCE: Chaer RA. Northwestern Vascular Symposium 2017.
REPORTING FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
Group Education Is Effective Migraine Intervention
Group education on headache evaluation and lifestyle management has potential as an effective, low-cost intervention for treatment of chronic headaches among adolescents, according to a recent study. This retrospective chart review study evaluated a group education program for 155 adolescents, aged 12-17 years, enrolled in the US military medical system with at least 3 months of chronic headaches and who were referred to a headache evaluation clinic. The primary outcome of the study was self-reported number of days with a headache in the previous 30 days based on patient recall. Researchers found:
- Most participants in the program were female (114/155 [73.5%]) and suffered from migraine headaches (108/155 [69.8%]).
- Severe headache-related disability was reported by 40.6% of subjects (63/155).
- Subjects reported an average of 19 days with headache during the previous 30 days.
- Participation in the group education was associated with an 11.5-day decrease in the frequency of headaches during the previous 30 days at follow-up at least 6 months after the class, with largest decline seen in patients with the highest level of migraine-related disability at baseline.
Group education and multidisciplinary management for chronic headaches among adolescents in a military treatment facility: A retrospective chart review. [Published online ahead of print February 7, 2018]. Headache. doi:10.1111/head.13274.
Group education on headache evaluation and lifestyle management has potential as an effective, low-cost intervention for treatment of chronic headaches among adolescents, according to a recent study. This retrospective chart review study evaluated a group education program for 155 adolescents, aged 12-17 years, enrolled in the US military medical system with at least 3 months of chronic headaches and who were referred to a headache evaluation clinic. The primary outcome of the study was self-reported number of days with a headache in the previous 30 days based on patient recall. Researchers found:
- Most participants in the program were female (114/155 [73.5%]) and suffered from migraine headaches (108/155 [69.8%]).
- Severe headache-related disability was reported by 40.6% of subjects (63/155).
- Subjects reported an average of 19 days with headache during the previous 30 days.
- Participation in the group education was associated with an 11.5-day decrease in the frequency of headaches during the previous 30 days at follow-up at least 6 months after the class, with largest decline seen in patients with the highest level of migraine-related disability at baseline.
Group education and multidisciplinary management for chronic headaches among adolescents in a military treatment facility: A retrospective chart review. [Published online ahead of print February 7, 2018]. Headache. doi:10.1111/head.13274.
Group education on headache evaluation and lifestyle management has potential as an effective, low-cost intervention for treatment of chronic headaches among adolescents, according to a recent study. This retrospective chart review study evaluated a group education program for 155 adolescents, aged 12-17 years, enrolled in the US military medical system with at least 3 months of chronic headaches and who were referred to a headache evaluation clinic. The primary outcome of the study was self-reported number of days with a headache in the previous 30 days based on patient recall. Researchers found:
- Most participants in the program were female (114/155 [73.5%]) and suffered from migraine headaches (108/155 [69.8%]).
- Severe headache-related disability was reported by 40.6% of subjects (63/155).
- Subjects reported an average of 19 days with headache during the previous 30 days.
- Participation in the group education was associated with an 11.5-day decrease in the frequency of headaches during the previous 30 days at follow-up at least 6 months after the class, with largest decline seen in patients with the highest level of migraine-related disability at baseline.
Group education and multidisciplinary management for chronic headaches among adolescents in a military treatment facility: A retrospective chart review. [Published online ahead of print February 7, 2018]. Headache. doi:10.1111/head.13274.
Splenic artery embolization increases risk of complications
LAKE BUENA VISTA, FLA. – are at higher risk of infectious complications and readmissions in the long term, according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
As nonoperative treatments are becoming more common for managing blunt splenic injury (BSI), it is important to understand the risks associated with splenic artery embolization (SAE) and how this treatment may be impacting a larger trend of posttrauma readmissions, according to presenter Rishi Rattan, MD, an acute care surgeon at the University of Miami.
The retrospective study included 37,986 BSI patients admitted into the National Readmissions Database from 2010 to 2014, treated with either nonoperative management (NOM), SAE, or operative management (OM).
Readmission rates for infection after 30 days were significantly higher among SAE (15.4%) and OM (21.9%) patients, compared with NOM patients (6.7%), according to Dr. Rattan. Patients who underwent SAE also had a 17.2% rate of infection after 1 year; significantly higher than the 8.1% of patients who underwent NOM, although less than the 23.2% of those who underwent OM.
For readmission due to organ surgical site infection, patients with SAE had a higher frequency at 30-day (2.9%) and 1-year (3.9%) readmission, compared with both NOM (1.3%, 1.7%) and OM (2.0%, 2.2%).
This can be particularly problematic as these organ surgical site infections, deep in the abdominal cavity around the splenic bed, are usually more complicated to manage, compared with a superficial infection, explained Dr. Rattan. Physiologically, it makes sense that having dead tissue left in the splenic bed could lead to a rise in infection, although more data are necessary to confirm that hypothesis.
SAE was a significant predictive factor for complications after BSI, increasing the odds of 30-day and 1-year readmission by 76% and 99%, respectively, from organ surgical site infection, compared with NOM (P less than .01). Other predictive factors included hospital stays longer than 4 days, not being discharged to home, and a Charlson Comorbidity index score greater than 1.
With an incidence rate of readmission among embolization patients at 30 days and 1 year double that of NOM, Dr. Rattan and fellow investigators suggest surgeons should be conscious of the risks of SAE and OM, especially as infection is a major case of morbidity after trauma in splenectomy patients.
The investigators reported no relevant financial disclosures.
LAKE BUENA VISTA, FLA. – are at higher risk of infectious complications and readmissions in the long term, according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
As nonoperative treatments are becoming more common for managing blunt splenic injury (BSI), it is important to understand the risks associated with splenic artery embolization (SAE) and how this treatment may be impacting a larger trend of posttrauma readmissions, according to presenter Rishi Rattan, MD, an acute care surgeon at the University of Miami.
The retrospective study included 37,986 BSI patients admitted into the National Readmissions Database from 2010 to 2014, treated with either nonoperative management (NOM), SAE, or operative management (OM).
Readmission rates for infection after 30 days were significantly higher among SAE (15.4%) and OM (21.9%) patients, compared with NOM patients (6.7%), according to Dr. Rattan. Patients who underwent SAE also had a 17.2% rate of infection after 1 year; significantly higher than the 8.1% of patients who underwent NOM, although less than the 23.2% of those who underwent OM.
For readmission due to organ surgical site infection, patients with SAE had a higher frequency at 30-day (2.9%) and 1-year (3.9%) readmission, compared with both NOM (1.3%, 1.7%) and OM (2.0%, 2.2%).
This can be particularly problematic as these organ surgical site infections, deep in the abdominal cavity around the splenic bed, are usually more complicated to manage, compared with a superficial infection, explained Dr. Rattan. Physiologically, it makes sense that having dead tissue left in the splenic bed could lead to a rise in infection, although more data are necessary to confirm that hypothesis.
SAE was a significant predictive factor for complications after BSI, increasing the odds of 30-day and 1-year readmission by 76% and 99%, respectively, from organ surgical site infection, compared with NOM (P less than .01). Other predictive factors included hospital stays longer than 4 days, not being discharged to home, and a Charlson Comorbidity index score greater than 1.
With an incidence rate of readmission among embolization patients at 30 days and 1 year double that of NOM, Dr. Rattan and fellow investigators suggest surgeons should be conscious of the risks of SAE and OM, especially as infection is a major case of morbidity after trauma in splenectomy patients.
The investigators reported no relevant financial disclosures.
LAKE BUENA VISTA, FLA. – are at higher risk of infectious complications and readmissions in the long term, according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
As nonoperative treatments are becoming more common for managing blunt splenic injury (BSI), it is important to understand the risks associated with splenic artery embolization (SAE) and how this treatment may be impacting a larger trend of posttrauma readmissions, according to presenter Rishi Rattan, MD, an acute care surgeon at the University of Miami.
The retrospective study included 37,986 BSI patients admitted into the National Readmissions Database from 2010 to 2014, treated with either nonoperative management (NOM), SAE, or operative management (OM).
Readmission rates for infection after 30 days were significantly higher among SAE (15.4%) and OM (21.9%) patients, compared with NOM patients (6.7%), according to Dr. Rattan. Patients who underwent SAE also had a 17.2% rate of infection after 1 year; significantly higher than the 8.1% of patients who underwent NOM, although less than the 23.2% of those who underwent OM.
For readmission due to organ surgical site infection, patients with SAE had a higher frequency at 30-day (2.9%) and 1-year (3.9%) readmission, compared with both NOM (1.3%, 1.7%) and OM (2.0%, 2.2%).
This can be particularly problematic as these organ surgical site infections, deep in the abdominal cavity around the splenic bed, are usually more complicated to manage, compared with a superficial infection, explained Dr. Rattan. Physiologically, it makes sense that having dead tissue left in the splenic bed could lead to a rise in infection, although more data are necessary to confirm that hypothesis.
SAE was a significant predictive factor for complications after BSI, increasing the odds of 30-day and 1-year readmission by 76% and 99%, respectively, from organ surgical site infection, compared with NOM (P less than .01). Other predictive factors included hospital stays longer than 4 days, not being discharged to home, and a Charlson Comorbidity index score greater than 1.
With an incidence rate of readmission among embolization patients at 30 days and 1 year double that of NOM, Dr. Rattan and fellow investigators suggest surgeons should be conscious of the risks of SAE and OM, especially as infection is a major case of morbidity after trauma in splenectomy patients.
The investigators reported no relevant financial disclosures.
REPORTING FROM EAST 2018
Key clinical point: Splenic artery embolization can increase risk of infectious complications in patients with blunt splenic injury.
Major finding: Patients who underwent splenic artery embolization had an infectious complication rate of 20% after 1 year.
Data source: Study of 37,986 blunt splenic injury patients gathered from the Nationwide Readmissions Database during 2010-2014.
Disclosures: Investigators reported no relevant financial disclosures.
Nearly half of MS patients treated by primary docs miss out on meds
SAN DIEGO – than are those treated by neurologists, even though they have more symptoms.
Nearly 85% of those treated at MS centers by neurologists received the drugs, compared with just 51% of those treated at primary care offices, according to results of a study reported at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Dr. Halpern spoke in an interview at the ACTRIMS Forum.
The researchers analyzed data from the Sonya Slifka Longitudinal Multiple Sclerosis Study and focused on MS patients who received care at MS centers (376 patients, all treated by neurologists), neurology practices (552 patients), and primary care practices (55 patients).
In the three groups, most of the patients were female (77%-82%). To a statistically significant degree, those who were treated at primary care practices, compared with those at MS centers, were more likely to be white (98% vs. 82%), to have less than a college education (69% vs. 42%), and to have Medicaid/veteran coverage or be uninsured (22% vs. 11%).
In terms of rates of patients receiving disease-modifying therapies, there was a small difference between MS centers (84%) and neurology practices (79%); P less than .05.
However, the gap between these patients and those treated by primary care doctors was wide: Only 51% in the latter group received disease-modifying therapies, even though they reported more symptoms in areas such as vision, walking, bowel, speech, and numbness, compared with those in the other groups (P less than .05).
There was no statistically significant difference among the groups in reported symptoms of tremor, headache, pain, fatigue, cognition, swallowing, depression, mood, and anxiety.
The study doesn’t explain why the MS patients treated by primary care physicians are missing out on care, and it is not known whether the absence of treatment makes their conditions worse.
However, “it’s been well documented that the disease-modifying therapies can reduce the disease progression and the likelihood of experiencing relapses,” Dr. Halpern said. “Individuals with MS who are not being appropriately treated are more likely to experience symptoms, relapses, and faster disability.”
He speculated that primary care doctors may be falling behind on the treatment front because they lack the training and expertise to properly prescribe the MS medications, which are “difficult and complex drugs.”
Whatever the case, he said, there’s a clear need for more collaboration between MS subspecialists and primary care doctors.
The study was funded by the National MS Society. Dr. Halpern reported no relevant disclosures.
SOURCE: Halpern MT et al. ACTRIMS Forum 2018 Abstract P226.
SAN DIEGO – than are those treated by neurologists, even though they have more symptoms.
Nearly 85% of those treated at MS centers by neurologists received the drugs, compared with just 51% of those treated at primary care offices, according to results of a study reported at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Dr. Halpern spoke in an interview at the ACTRIMS Forum.
The researchers analyzed data from the Sonya Slifka Longitudinal Multiple Sclerosis Study and focused on MS patients who received care at MS centers (376 patients, all treated by neurologists), neurology practices (552 patients), and primary care practices (55 patients).
In the three groups, most of the patients were female (77%-82%). To a statistically significant degree, those who were treated at primary care practices, compared with those at MS centers, were more likely to be white (98% vs. 82%), to have less than a college education (69% vs. 42%), and to have Medicaid/veteran coverage or be uninsured (22% vs. 11%).
In terms of rates of patients receiving disease-modifying therapies, there was a small difference between MS centers (84%) and neurology practices (79%); P less than .05.
However, the gap between these patients and those treated by primary care doctors was wide: Only 51% in the latter group received disease-modifying therapies, even though they reported more symptoms in areas such as vision, walking, bowel, speech, and numbness, compared with those in the other groups (P less than .05).
There was no statistically significant difference among the groups in reported symptoms of tremor, headache, pain, fatigue, cognition, swallowing, depression, mood, and anxiety.
The study doesn’t explain why the MS patients treated by primary care physicians are missing out on care, and it is not known whether the absence of treatment makes their conditions worse.
However, “it’s been well documented that the disease-modifying therapies can reduce the disease progression and the likelihood of experiencing relapses,” Dr. Halpern said. “Individuals with MS who are not being appropriately treated are more likely to experience symptoms, relapses, and faster disability.”
He speculated that primary care doctors may be falling behind on the treatment front because they lack the training and expertise to properly prescribe the MS medications, which are “difficult and complex drugs.”
Whatever the case, he said, there’s a clear need for more collaboration between MS subspecialists and primary care doctors.
The study was funded by the National MS Society. Dr. Halpern reported no relevant disclosures.
SOURCE: Halpern MT et al. ACTRIMS Forum 2018 Abstract P226.
SAN DIEGO – than are those treated by neurologists, even though they have more symptoms.
Nearly 85% of those treated at MS centers by neurologists received the drugs, compared with just 51% of those treated at primary care offices, according to results of a study reported at ACTRIMS Forum 2018, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Dr. Halpern spoke in an interview at the ACTRIMS Forum.
The researchers analyzed data from the Sonya Slifka Longitudinal Multiple Sclerosis Study and focused on MS patients who received care at MS centers (376 patients, all treated by neurologists), neurology practices (552 patients), and primary care practices (55 patients).
In the three groups, most of the patients were female (77%-82%). To a statistically significant degree, those who were treated at primary care practices, compared with those at MS centers, were more likely to be white (98% vs. 82%), to have less than a college education (69% vs. 42%), and to have Medicaid/veteran coverage or be uninsured (22% vs. 11%).
In terms of rates of patients receiving disease-modifying therapies, there was a small difference between MS centers (84%) and neurology practices (79%); P less than .05.
However, the gap between these patients and those treated by primary care doctors was wide: Only 51% in the latter group received disease-modifying therapies, even though they reported more symptoms in areas such as vision, walking, bowel, speech, and numbness, compared with those in the other groups (P less than .05).
There was no statistically significant difference among the groups in reported symptoms of tremor, headache, pain, fatigue, cognition, swallowing, depression, mood, and anxiety.
The study doesn’t explain why the MS patients treated by primary care physicians are missing out on care, and it is not known whether the absence of treatment makes their conditions worse.
However, “it’s been well documented that the disease-modifying therapies can reduce the disease progression and the likelihood of experiencing relapses,” Dr. Halpern said. “Individuals with MS who are not being appropriately treated are more likely to experience symptoms, relapses, and faster disability.”
He speculated that primary care doctors may be falling behind on the treatment front because they lack the training and expertise to properly prescribe the MS medications, which are “difficult and complex drugs.”
Whatever the case, he said, there’s a clear need for more collaboration between MS subspecialists and primary care doctors.
The study was funded by the National MS Society. Dr. Halpern reported no relevant disclosures.
SOURCE: Halpern MT et al. ACTRIMS Forum 2018 Abstract P226.
REPORTING FROM ACTRIMS FORUM 2018