The Food and Drug Administration has designated bertilimumab as an orphan drug for the treatment of bullous pemphigoid, according to an announcement issued by the company that is developing the treatment.

The company, Immune Pharmaceuticals, plans to launch a pivotal phase 2/3 study in 2019, the company said in an Aug. 20 press release. Two phase 2 studies of bertilimumab are currently underway, one in patients with bullous pemphigoid, and another in patients with ulcerative colitis. Bertilimumab is “a first-in-class, fully human monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation,” the statement said.“By neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells, thus helping to relieve associated inflammatory conditions.”

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA’s Orphan Drug Designation program grants orphan status to drugs and biologics, which are “defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug,” according to the agency.

[email protected]

The Food and Drug Administration has designated bertilimumab as an orphan drug for the treatment of bullous pemphigoid, according to an announcement issued by the company that is developing the treatment.

The company, Immune Pharmaceuticals, plans to launch a pivotal phase 2/3 study in 2019, the company said in an Aug. 20 press release. Two phase 2 studies of bertilimumab are currently underway, one in patients with bullous pemphigoid, and another in patients with ulcerative colitis. Bertilimumab is “a first-in-class, fully human monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation,” the statement said.“By neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells, thus helping to relieve associated inflammatory conditions.”

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA’s Orphan Drug Designation program grants orphan status to drugs and biologics, which are “defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug,” according to the agency.

[email protected]

The Food and Drug Administration has designated bertilimumab as an orphan drug for the treatment of bullous pemphigoid, according to an announcement issued by the company that is developing the treatment.

The company, Immune Pharmaceuticals, plans to launch a pivotal phase 2/3 study in 2019, the company said in an Aug. 20 press release. Two phase 2 studies of bertilimumab are currently underway, one in patients with bullous pemphigoid, and another in patients with ulcerative colitis. Bertilimumab is “a first-in-class, fully human monoclonal antibody that targets and lowers levels of eotaxin-1, a chemokine that plays a role in immune responses and attracts eosinophils to the site of inflammation,” the statement said.“By neutralizing eotaxin-1, bertilimumab may prevent the migration of eosinophils and other cells, thus helping to relieve associated inflammatory conditions.”

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA’s Orphan Drug Designation program grants orphan status to drugs and biologics, which are “defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug,” according to the agency.

[email protected]

Oral prednisone for children with at least 3 months of otitis media with effusion (OME) was a well tolerated but not effective treatment, because many participants had spontaneous resolution of their symptoms, according to results from a randomized, parallel, double-blinded, placebo-controlled trial.

“If effective, a short course of oral steroids for otitis media with effusion would have been appealing as the treatment is generally well tolerated and would avoid more burdensome and expensive interventions such as ventilation tubes or hearing aids,” Nick A. Francis, PhD, of Cardiff University, Wales, and his colleagues wrote in the Lancet.

Dr. Francis and his colleagues enrolled 389 children aged 2-8 years with symptoms of OME from 20 ear, nose, and throat outpatient medical departments into the OSTRICH trial between March 2014 and April 2016, where they were randomized to receive a 7-day course of once daily oral prednisone at 20 mg for children aged 2-5 years and 30 mg for children 6-8 years (total of 200 patients), or placebo (189 patients). Some patients had symptoms of hearing loss from their condition so 183 participants in the oral steroid group and 180 participants in the placebo group underwent a hearing test 4 weeks after treatment.

At 5 weeks, Dr. Francis and his colleagues found that 40% of 183 patients in the oral steroid group and 53% of 180 in the placebo group achieved acceptable hearing after treatment, a small nonsignificant between group difference (absolute difference, 7%; 95% confidence interval, –3 to 17). However, the number needed to treat was 14 to 1, and there was a high number of spontaneous resolutions of symptoms in the study, they said. In addition, there were no between-group differences in adverse events or quality of life.

While they do not recommend routine oral steroids for children in this setting based on limited clinical significance, the investigators suggested oral steroids may be a “reasonable candidate intervention” for treatment of children in other patient populations.

“The high rate of spontaneous resolution identified in this study will support the evidence base informing discussions about watchful waiting in children with hearing loss associated with otitis media with effusion. Given the findings of some benefit from antibiotics for otitis media with effusion in children, and limited trial evidence for a benefit from oral steroids in combination with antibiotics, a rigorous trial of oral steroids combined with antibiotics might be indicated,” Dr. Francis and his colleagues wrote.

The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors reported no conflicts of interest.

SOURCE: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.

Oral prednisone for children with at least 3 months of otitis media with effusion (OME) was a well tolerated but not effective treatment, because many participants had spontaneous resolution of their symptoms, according to results from a randomized, parallel, double-blinded, placebo-controlled trial.

“If effective, a short course of oral steroids for otitis media with effusion would have been appealing as the treatment is generally well tolerated and would avoid more burdensome and expensive interventions such as ventilation tubes or hearing aids,” Nick A. Francis, PhD, of Cardiff University, Wales, and his colleagues wrote in the Lancet.

Dr. Francis and his colleagues enrolled 389 children aged 2-8 years with symptoms of OME from 20 ear, nose, and throat outpatient medical departments into the OSTRICH trial between March 2014 and April 2016, where they were randomized to receive a 7-day course of once daily oral prednisone at 20 mg for children aged 2-5 years and 30 mg for children 6-8 years (total of 200 patients), or placebo (189 patients). Some patients had symptoms of hearing loss from their condition so 183 participants in the oral steroid group and 180 participants in the placebo group underwent a hearing test 4 weeks after treatment.

At 5 weeks, Dr. Francis and his colleagues found that 40% of 183 patients in the oral steroid group and 53% of 180 in the placebo group achieved acceptable hearing after treatment, a small nonsignificant between group difference (absolute difference, 7%; 95% confidence interval, –3 to 17). However, the number needed to treat was 14 to 1, and there was a high number of spontaneous resolutions of symptoms in the study, they said. In addition, there were no between-group differences in adverse events or quality of life.

While they do not recommend routine oral steroids for children in this setting based on limited clinical significance, the investigators suggested oral steroids may be a “reasonable candidate intervention” for treatment of children in other patient populations.

“The high rate of spontaneous resolution identified in this study will support the evidence base informing discussions about watchful waiting in children with hearing loss associated with otitis media with effusion. Given the findings of some benefit from antibiotics for otitis media with effusion in children, and limited trial evidence for a benefit from oral steroids in combination with antibiotics, a rigorous trial of oral steroids combined with antibiotics might be indicated,” Dr. Francis and his colleagues wrote.

The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors reported no conflicts of interest.

SOURCE: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.

Oral prednisone for children with at least 3 months of otitis media with effusion (OME) was a well tolerated but not effective treatment, because many participants had spontaneous resolution of their symptoms, according to results from a randomized, parallel, double-blinded, placebo-controlled trial.

“If effective, a short course of oral steroids for otitis media with effusion would have been appealing as the treatment is generally well tolerated and would avoid more burdensome and expensive interventions such as ventilation tubes or hearing aids,” Nick A. Francis, PhD, of Cardiff University, Wales, and his colleagues wrote in the Lancet.

Dr. Francis and his colleagues enrolled 389 children aged 2-8 years with symptoms of OME from 20 ear, nose, and throat outpatient medical departments into the OSTRICH trial between March 2014 and April 2016, where they were randomized to receive a 7-day course of once daily oral prednisone at 20 mg for children aged 2-5 years and 30 mg for children 6-8 years (total of 200 patients), or placebo (189 patients). Some patients had symptoms of hearing loss from their condition so 183 participants in the oral steroid group and 180 participants in the placebo group underwent a hearing test 4 weeks after treatment.

At 5 weeks, Dr. Francis and his colleagues found that 40% of 183 patients in the oral steroid group and 53% of 180 in the placebo group achieved acceptable hearing after treatment, a small nonsignificant between group difference (absolute difference, 7%; 95% confidence interval, –3 to 17). However, the number needed to treat was 14 to 1, and there was a high number of spontaneous resolutions of symptoms in the study, they said. In addition, there were no between-group differences in adverse events or quality of life.

While they do not recommend routine oral steroids for children in this setting based on limited clinical significance, the investigators suggested oral steroids may be a “reasonable candidate intervention” for treatment of children in other patient populations.

“The high rate of spontaneous resolution identified in this study will support the evidence base informing discussions about watchful waiting in children with hearing loss associated with otitis media with effusion. Given the findings of some benefit from antibiotics for otitis media with effusion in children, and limited trial evidence for a benefit from oral steroids in combination with antibiotics, a rigorous trial of oral steroids combined with antibiotics might be indicated,” Dr. Francis and his colleagues wrote.

The OSTRICH Trial was funded by the National Institute for Health Research Health Technology Assessment program. The authors reported no conflicts of interest.

SOURCE: Francis NA et al. Lancet. 2018 Aug 18. doi: 10.1016/S0140-6736(18)31490-9.

Medical associations are expressing disappointment at the new payment scheme put forward by the Centers for Medicare & Medicaid Services for inpatient administration of two chimeric antigen receptor (CAR) T-cell therapies, calling the reimbursement insufficient for use of the expensive medications.

Courtesy Novartis

Under its Aug. 17 final rule, CMS will now categorize CAR T-cell therapies under the umbrella of the renamed Medicare Severity–Diagnosis Related Groups (MS-DRG) 016 – Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy – and assign ICD-10-PCS procedure codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) in the inpatient setting for fiscal year 2019, which begins in October 2018.

CMS also approved a temporary New Technology Add-On Payment (NTAP) for use of the therapies with a maximum threshold of $186,500, according to the rule.

According to the American Society of Hematology (ASH), this payment structure is an improvement, but it hardly covers the cost of the products, nor does it account for full hospitalization costs. ASH noted that the revised MS-DRG 016 has a base payment rate of $36,000 and that the maximum NTAP payment ($186,500) is only about half of the cost for a CAR T-cell product.

“ASH is concerned that this final policy may impede access to care to this cutting-edge therapy because hospitals and academic medical centers that provide this personalized treatment will simply not be able to withstand the negative financial impact,” the society said in a statement. “While this final policy represents an improvement over current CAR T therapy reimbursement rates, ASH believes patient access to care will be jeopardized as providers and hospitals will not be able to afford to deliver the therapy at this reimbursement rate, particularly as other CAR T products receive FDA [Food and Drug Administration] approval.”

ASH and the American Society for Blood and Marrow Transplantation (ASBMT) had strongly urged CMS to develop a site-neutral, equitable payment structure that would have allowed providers to recover more product acquisition costs from CAR T-cell therapies. In its final rule, CMS stated that it was too early to develop a novel payment structure for CAR T-cell treatments and that more research is needed before such changes are made. The agency noted that in May CMS opened a national coverage determination analysis on CAR T-cell therapy for Medicare patients with advanced cancer, which is expected to be completed by May 2019.

“[CMS] is soliciting public comment … on key design considerations for developing a potential model that would test private market strategies and introduce competition to improve quality of care for beneficiaries,” the agency said in the rule. “Given the relative newness of CAR T-cell therapy, the potential model, and our request for feedback on this model approach, we believe it would be premature to adopt changes to our existing payment mechanisms.”

The payment outline by CMS is essentially the bare minimum it could have extended to CAR T-cell therapies for 2019, said Stephanie Farnia, director of health policy and strategic relations for the ASBMT.

“[ASBMT] and a number of stakeholders have been very clear in our comment letters that that would not be enough and the reasons why,” Ms. Farnia said in an interview. “It’s not going to be sufficient to cover the cost of care or the product.”

The rule also fails to address the cancer centers that are exempt from the DRG payment system, Ms. Farnia said. Eleven centers are excluded from the payment system because of past legislation that excludes exclusive cancer hospitals that do not provide noncancer services. The exempt cancer centers cannot receive additional money for new or expensive drugs and therefore will not gain any financial relief from the CAR T-cell therapy payment changes in the CMS final rule.

ASH officials plan to follow up with congressional leaders to identify ways to improve future CAR T-cell therapy payments, including a potential legislative solution. An ASH spokesperson declined to elaborate on its ideal legislative remedy.

Hospital administrators and physicians will need to have difficult conversations in the upcoming year about whether treating patients with CAR T-cell therapies is worth the cost deficits, Ms. Farnia said.

“Everyone was really counting on it being a different reimbursement scenario for the upcoming fiscal year, and it is, but again, it’s that bare minimum difference,” Ms. Farnia said. “I think a number of programs are going to be taking a look at their financial experience thus far and comparing that to the reimbursement and deciding on if they [should] continue to offer it and how to do that.”

In April 2018, CMS announced payment rates for outpatient administration of the two drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.

However, physicians have raised concerns that even if the drugs are first administered in the outpatient setting, inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted in order to be monitored for serious side effects. In such cases, all payments will become part of the inpatient stay under CMS’s 3-day payment window rule.

Medical associations are expressing disappointment at the new payment scheme put forward by the Centers for Medicare & Medicaid Services for inpatient administration of two chimeric antigen receptor (CAR) T-cell therapies, calling the reimbursement insufficient for use of the expensive medications.

Courtesy Novartis

Under its Aug. 17 final rule, CMS will now categorize CAR T-cell therapies under the umbrella of the renamed Medicare Severity–Diagnosis Related Groups (MS-DRG) 016 – Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy – and assign ICD-10-PCS procedure codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) in the inpatient setting for fiscal year 2019, which begins in October 2018.

CMS also approved a temporary New Technology Add-On Payment (NTAP) for use of the therapies with a maximum threshold of $186,500, according to the rule.

According to the American Society of Hematology (ASH), this payment structure is an improvement, but it hardly covers the cost of the products, nor does it account for full hospitalization costs. ASH noted that the revised MS-DRG 016 has a base payment rate of $36,000 and that the maximum NTAP payment ($186,500) is only about half of the cost for a CAR T-cell product.

“ASH is concerned that this final policy may impede access to care to this cutting-edge therapy because hospitals and academic medical centers that provide this personalized treatment will simply not be able to withstand the negative financial impact,” the society said in a statement. “While this final policy represents an improvement over current CAR T therapy reimbursement rates, ASH believes patient access to care will be jeopardized as providers and hospitals will not be able to afford to deliver the therapy at this reimbursement rate, particularly as other CAR T products receive FDA [Food and Drug Administration] approval.”

ASH and the American Society for Blood and Marrow Transplantation (ASBMT) had strongly urged CMS to develop a site-neutral, equitable payment structure that would have allowed providers to recover more product acquisition costs from CAR T-cell therapies. In its final rule, CMS stated that it was too early to develop a novel payment structure for CAR T-cell treatments and that more research is needed before such changes are made. The agency noted that in May CMS opened a national coverage determination analysis on CAR T-cell therapy for Medicare patients with advanced cancer, which is expected to be completed by May 2019.

“[CMS] is soliciting public comment … on key design considerations for developing a potential model that would test private market strategies and introduce competition to improve quality of care for beneficiaries,” the agency said in the rule. “Given the relative newness of CAR T-cell therapy, the potential model, and our request for feedback on this model approach, we believe it would be premature to adopt changes to our existing payment mechanisms.”

The payment outline by CMS is essentially the bare minimum it could have extended to CAR T-cell therapies for 2019, said Stephanie Farnia, director of health policy and strategic relations for the ASBMT.

“[ASBMT] and a number of stakeholders have been very clear in our comment letters that that would not be enough and the reasons why,” Ms. Farnia said in an interview. “It’s not going to be sufficient to cover the cost of care or the product.”

The rule also fails to address the cancer centers that are exempt from the DRG payment system, Ms. Farnia said. Eleven centers are excluded from the payment system because of past legislation that excludes exclusive cancer hospitals that do not provide noncancer services. The exempt cancer centers cannot receive additional money for new or expensive drugs and therefore will not gain any financial relief from the CAR T-cell therapy payment changes in the CMS final rule.

ASH officials plan to follow up with congressional leaders to identify ways to improve future CAR T-cell therapy payments, including a potential legislative solution. An ASH spokesperson declined to elaborate on its ideal legislative remedy.

Hospital administrators and physicians will need to have difficult conversations in the upcoming year about whether treating patients with CAR T-cell therapies is worth the cost deficits, Ms. Farnia said.

“Everyone was really counting on it being a different reimbursement scenario for the upcoming fiscal year, and it is, but again, it’s that bare minimum difference,” Ms. Farnia said. “I think a number of programs are going to be taking a look at their financial experience thus far and comparing that to the reimbursement and deciding on if they [should] continue to offer it and how to do that.”

In April 2018, CMS announced payment rates for outpatient administration of the two drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.

However, physicians have raised concerns that even if the drugs are first administered in the outpatient setting, inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted in order to be monitored for serious side effects. In such cases, all payments will become part of the inpatient stay under CMS’s 3-day payment window rule.

Medical associations are expressing disappointment at the new payment scheme put forward by the Centers for Medicare & Medicaid Services for inpatient administration of two chimeric antigen receptor (CAR) T-cell therapies, calling the reimbursement insufficient for use of the expensive medications.

Courtesy Novartis

Under its Aug. 17 final rule, CMS will now categorize CAR T-cell therapies under the umbrella of the renamed Medicare Severity–Diagnosis Related Groups (MS-DRG) 016 – Autologous Bone Marrow Transplant with CC/MCC or T-cell Immunotherapy – and assign ICD-10-PCS procedure codes XW033C3 and XW043C3 to the use of axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) in the inpatient setting for fiscal year 2019, which begins in October 2018.

CMS also approved a temporary New Technology Add-On Payment (NTAP) for use of the therapies with a maximum threshold of $186,500, according to the rule.

According to the American Society of Hematology (ASH), this payment structure is an improvement, but it hardly covers the cost of the products, nor does it account for full hospitalization costs. ASH noted that the revised MS-DRG 016 has a base payment rate of $36,000 and that the maximum NTAP payment ($186,500) is only about half of the cost for a CAR T-cell product.

“ASH is concerned that this final policy may impede access to care to this cutting-edge therapy because hospitals and academic medical centers that provide this personalized treatment will simply not be able to withstand the negative financial impact,” the society said in a statement. “While this final policy represents an improvement over current CAR T therapy reimbursement rates, ASH believes patient access to care will be jeopardized as providers and hospitals will not be able to afford to deliver the therapy at this reimbursement rate, particularly as other CAR T products receive FDA [Food and Drug Administration] approval.”

ASH and the American Society for Blood and Marrow Transplantation (ASBMT) had strongly urged CMS to develop a site-neutral, equitable payment structure that would have allowed providers to recover more product acquisition costs from CAR T-cell therapies. In its final rule, CMS stated that it was too early to develop a novel payment structure for CAR T-cell treatments and that more research is needed before such changes are made. The agency noted that in May CMS opened a national coverage determination analysis on CAR T-cell therapy for Medicare patients with advanced cancer, which is expected to be completed by May 2019.

“[CMS] is soliciting public comment … on key design considerations for developing a potential model that would test private market strategies and introduce competition to improve quality of care for beneficiaries,” the agency said in the rule. “Given the relative newness of CAR T-cell therapy, the potential model, and our request for feedback on this model approach, we believe it would be premature to adopt changes to our existing payment mechanisms.”

The payment outline by CMS is essentially the bare minimum it could have extended to CAR T-cell therapies for 2019, said Stephanie Farnia, director of health policy and strategic relations for the ASBMT.

“[ASBMT] and a number of stakeholders have been very clear in our comment letters that that would not be enough and the reasons why,” Ms. Farnia said in an interview. “It’s not going to be sufficient to cover the cost of care or the product.”

The rule also fails to address the cancer centers that are exempt from the DRG payment system, Ms. Farnia said. Eleven centers are excluded from the payment system because of past legislation that excludes exclusive cancer hospitals that do not provide noncancer services. The exempt cancer centers cannot receive additional money for new or expensive drugs and therefore will not gain any financial relief from the CAR T-cell therapy payment changes in the CMS final rule.

ASH officials plan to follow up with congressional leaders to identify ways to improve future CAR T-cell therapy payments, including a potential legislative solution. An ASH spokesperson declined to elaborate on its ideal legislative remedy.

Hospital administrators and physicians will need to have difficult conversations in the upcoming year about whether treating patients with CAR T-cell therapies is worth the cost deficits, Ms. Farnia said.

“Everyone was really counting on it being a different reimbursement scenario for the upcoming fiscal year, and it is, but again, it’s that bare minimum difference,” Ms. Farnia said. “I think a number of programs are going to be taking a look at their financial experience thus far and comparing that to the reimbursement and deciding on if they [should] continue to offer it and how to do that.”

In April 2018, CMS announced payment rates for outpatient administration of the two drugs, settling on $395,380 for axicabtagene ciloleucel and $500,839 for tisagenlecleucel. The two medications have list prices of $373,000 and $475,000, respectively.

However, physicians have raised concerns that even if the drugs are first administered in the outpatient setting, inpatient care is likely to occur with CAR T-cell therapies because some patients will need to be admitted in order to be monitored for serious side effects. In such cases, all payments will become part of the inpatient stay under CMS’s 3-day payment window rule.

Screen women for cervical cancer with basic cytology starting at age 21 years, and consider adding high-risk human papillomavirus (hrHPV) testing alone or with cytology for women aged 30 years and older, the U.S. Preventive Services Task Force recommended in an updated statement on cervical cancer screening .

The statement, accompanying evidence report, and a modeling study were published online in JAMA.

Cervical cancer deaths in the United States have declined from 2.8 deaths per 100,000 women in 2000 to 2.3 deaths per 100,000 women in 2015 because of the adoption of widespread screening, according to Susan J. Curry, PhD., of the University of Iowa, Iowa City, and her colleagues in the USPSTF (JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10897.

Based on the latest evidence and the modeling study, the USPSTF gives an A recommendation to screening women aged 21-29 years for cervical cancer every 3 years with cervical cytology alone. The task force also gives an A to screening women aged 30-65 years every 5 years with either hrHPV testing alone or in combination with cytology.

The task force recommends against screening (D recommendation) for women younger than 21 years, older than 65 years with a history of screening and low cervical cancer risk, and women who have had hysterectomies with removal of the cervix and no history of cervical cancer risk.

To update the previous recommendations issued in 2012, the task force reviewed the latest evidence and commissioned a modeling study to help determine the best screening strategies in terms of age, screening intervals, and risks vs. benefits.

In the model, researchers assessed 19 strategies for cervical cancer screening based on a hypothetical cohort of women who began screening at 21 years of age.

Overall, the different strategies were similar in effectiveness, but primary hrHPV testing and alternative cotesting were slightly more effective: Cervical cancer deaths ranged from 0.23 to 0.29 deaths per 1,000 women in strategies involving hrHPV testing or cotesting, vs. 0.30 to 0.76 deaths per 1,000 women for strategies based on the current guidelines.

In addition, switching the age of hrHPV testing from 25 years to 30 years and using a 5-year screening interval showed the most effectiveness in terms of risks vs. harms, wrote Jane K. Kim, PhD, of Harvard University, Boston, and her colleagues (JAMA. 2018 Aug 21. doi: 10.1001/jama.2017.19872). “Switching from cytology to 5-year primary hrHPV testing at age 30 years (strategy 14) was associated with a ratio of 640 colposcopies per cancer case averted; earlier switch ages required a greater number of colposcopies per cancer case averted.”

The recommendations also were supported by an evidence report including eight randomized, controlled trials of 410,556 women, five cohort studies of 402,615 women, and a meta-analysis of individual participant data including 176,464 women.

The evidence report sought to address the benefits and harms of cervical cancer screening using hrHPV screening alone as the primary screening method or paired with cytology (cotesting), compared with primary screening using cytology alone.

Overall, both hrHPV and hrHPV plus cytology were associated with higher rates of false-positives and colposcopy compared with cytology alone, “which could lead to more treatments with potential harms,” wrote Joy Melnikow, MD, of the University of California, Davis, and her colleagues (JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10400.

In addition, hrHPV testing yielded higher rates of positive cervical intraepithelial neoplasia, compared with cytology alone as initial screening.

However, further research is needed to address the impact of any cervical cancer screening strategies in populations with limited access to health care and screening, the researchers noted.

The updated USPSTF recommendations are largely in line with those issued by leading women’s health organizations including the American College of Obstetricians and Gynecologists, ASCCP, and the Society for Gynecologic Oncology, according to a joint statement.

“With a number of screening options now available, the new guidelines emphasize the importance of the patient-provider shared decision-making process to assist women in making an informed choice about which screening method is most suitable for them,” according to the statement, “However, more importantly, there needs to be a continued effort to ensure all women are adequately screened because a significant number of women in the country are not. It’s also essential for women to have access to all of the tests and that they are appropriately covered by insurance companies.

“We hope the USPSTF recommendations foster more discussions between patients and providers about cervical cancer screening, promote opportunities for patient education on the benefits and safety of HPV vaccination for cervical cancer prevention and encourage providers to offer HPV vaccines in their offices,” the statement noted.

The USPSTF research was funded by the Agency for Healthcare Research and Quality. The researchers for the modeling report were supported in part by a National Cancer Institute grant. The researchers had no relevant financial conflicts to disclose.

SOURCES: Kim J et al. JAMA. 2018 Aug 21. doi: 10.1001/jama.2017.19872; Melnikow J et al. JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10400; Curry S et al. JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10897.

Screen women for cervical cancer with basic cytology starting at age 21 years, and consider adding high-risk human papillomavirus (hrHPV) testing alone or with cytology for women aged 30 years and older, the U.S. Preventive Services Task Force recommended in an updated statement on cervical cancer screening .

The statement, accompanying evidence report, and a modeling study were published online in JAMA.

Cervical cancer deaths in the United States have declined from 2.8 deaths per 100,000 women in 2000 to 2.3 deaths per 100,000 women in 2015 because of the adoption of widespread screening, according to Susan J. Curry, PhD., of the University of Iowa, Iowa City, and her colleagues in the USPSTF (JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10897.

Based on the latest evidence and the modeling study, the USPSTF gives an A recommendation to screening women aged 21-29 years for cervical cancer every 3 years with cervical cytology alone. The task force also gives an A to screening women aged 30-65 years every 5 years with either hrHPV testing alone or in combination with cytology.

The task force recommends against screening (D recommendation) for women younger than 21 years, older than 65 years with a history of screening and low cervical cancer risk, and women who have had hysterectomies with removal of the cervix and no history of cervical cancer risk.

To update the previous recommendations issued in 2012, the task force reviewed the latest evidence and commissioned a modeling study to help determine the best screening strategies in terms of age, screening intervals, and risks vs. benefits.

In the model, researchers assessed 19 strategies for cervical cancer screening based on a hypothetical cohort of women who began screening at 21 years of age.

Overall, the different strategies were similar in effectiveness, but primary hrHPV testing and alternative cotesting were slightly more effective: Cervical cancer deaths ranged from 0.23 to 0.29 deaths per 1,000 women in strategies involving hrHPV testing or cotesting, vs. 0.30 to 0.76 deaths per 1,000 women for strategies based on the current guidelines.

In addition, switching the age of hrHPV testing from 25 years to 30 years and using a 5-year screening interval showed the most effectiveness in terms of risks vs. harms, wrote Jane K. Kim, PhD, of Harvard University, Boston, and her colleagues (JAMA. 2018 Aug 21. doi: 10.1001/jama.2017.19872). “Switching from cytology to 5-year primary hrHPV testing at age 30 years (strategy 14) was associated with a ratio of 640 colposcopies per cancer case averted; earlier switch ages required a greater number of colposcopies per cancer case averted.”

The recommendations also were supported by an evidence report including eight randomized, controlled trials of 410,556 women, five cohort studies of 402,615 women, and a meta-analysis of individual participant data including 176,464 women.

The evidence report sought to address the benefits and harms of cervical cancer screening using hrHPV screening alone as the primary screening method or paired with cytology (cotesting), compared with primary screening using cytology alone.

Overall, both hrHPV and hrHPV plus cytology were associated with higher rates of false-positives and colposcopy compared with cytology alone, “which could lead to more treatments with potential harms,” wrote Joy Melnikow, MD, of the University of California, Davis, and her colleagues (JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10400.

In addition, hrHPV testing yielded higher rates of positive cervical intraepithelial neoplasia, compared with cytology alone as initial screening.

However, further research is needed to address the impact of any cervical cancer screening strategies in populations with limited access to health care and screening, the researchers noted.

The updated USPSTF recommendations are largely in line with those issued by leading women’s health organizations including the American College of Obstetricians and Gynecologists, ASCCP, and the Society for Gynecologic Oncology, according to a joint statement.

“With a number of screening options now available, the new guidelines emphasize the importance of the patient-provider shared decision-making process to assist women in making an informed choice about which screening method is most suitable for them,” according to the statement, “However, more importantly, there needs to be a continued effort to ensure all women are adequately screened because a significant number of women in the country are not. It’s also essential for women to have access to all of the tests and that they are appropriately covered by insurance companies.

“We hope the USPSTF recommendations foster more discussions between patients and providers about cervical cancer screening, promote opportunities for patient education on the benefits and safety of HPV vaccination for cervical cancer prevention and encourage providers to offer HPV vaccines in their offices,” the statement noted.

The USPSTF research was funded by the Agency for Healthcare Research and Quality. The researchers for the modeling report were supported in part by a National Cancer Institute grant. The researchers had no relevant financial conflicts to disclose.

SOURCES: Kim J et al. JAMA. 2018 Aug 21. doi: 10.1001/jama.2017.19872; Melnikow J et al. JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10400; Curry S et al. JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10897.

Screen women for cervical cancer with basic cytology starting at age 21 years, and consider adding high-risk human papillomavirus (hrHPV) testing alone or with cytology for women aged 30 years and older, the U.S. Preventive Services Task Force recommended in an updated statement on cervical cancer screening .

The statement, accompanying evidence report, and a modeling study were published online in JAMA.

Cervical cancer deaths in the United States have declined from 2.8 deaths per 100,000 women in 2000 to 2.3 deaths per 100,000 women in 2015 because of the adoption of widespread screening, according to Susan J. Curry, PhD., of the University of Iowa, Iowa City, and her colleagues in the USPSTF (JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10897.

Based on the latest evidence and the modeling study, the USPSTF gives an A recommendation to screening women aged 21-29 years for cervical cancer every 3 years with cervical cytology alone. The task force also gives an A to screening women aged 30-65 years every 5 years with either hrHPV testing alone or in combination with cytology.

The task force recommends against screening (D recommendation) for women younger than 21 years, older than 65 years with a history of screening and low cervical cancer risk, and women who have had hysterectomies with removal of the cervix and no history of cervical cancer risk.

To update the previous recommendations issued in 2012, the task force reviewed the latest evidence and commissioned a modeling study to help determine the best screening strategies in terms of age, screening intervals, and risks vs. benefits.

In the model, researchers assessed 19 strategies for cervical cancer screening based on a hypothetical cohort of women who began screening at 21 years of age.

Overall, the different strategies were similar in effectiveness, but primary hrHPV testing and alternative cotesting were slightly more effective: Cervical cancer deaths ranged from 0.23 to 0.29 deaths per 1,000 women in strategies involving hrHPV testing or cotesting, vs. 0.30 to 0.76 deaths per 1,000 women for strategies based on the current guidelines.

In addition, switching the age of hrHPV testing from 25 years to 30 years and using a 5-year screening interval showed the most effectiveness in terms of risks vs. harms, wrote Jane K. Kim, PhD, of Harvard University, Boston, and her colleagues (JAMA. 2018 Aug 21. doi: 10.1001/jama.2017.19872). “Switching from cytology to 5-year primary hrHPV testing at age 30 years (strategy 14) was associated with a ratio of 640 colposcopies per cancer case averted; earlier switch ages required a greater number of colposcopies per cancer case averted.”

The recommendations also were supported by an evidence report including eight randomized, controlled trials of 410,556 women, five cohort studies of 402,615 women, and a meta-analysis of individual participant data including 176,464 women.

The evidence report sought to address the benefits and harms of cervical cancer screening using hrHPV screening alone as the primary screening method or paired with cytology (cotesting), compared with primary screening using cytology alone.

Overall, both hrHPV and hrHPV plus cytology were associated with higher rates of false-positives and colposcopy compared with cytology alone, “which could lead to more treatments with potential harms,” wrote Joy Melnikow, MD, of the University of California, Davis, and her colleagues (JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10400.

In addition, hrHPV testing yielded higher rates of positive cervical intraepithelial neoplasia, compared with cytology alone as initial screening.

However, further research is needed to address the impact of any cervical cancer screening strategies in populations with limited access to health care and screening, the researchers noted.

The updated USPSTF recommendations are largely in line with those issued by leading women’s health organizations including the American College of Obstetricians and Gynecologists, ASCCP, and the Society for Gynecologic Oncology, according to a joint statement.

“With a number of screening options now available, the new guidelines emphasize the importance of the patient-provider shared decision-making process to assist women in making an informed choice about which screening method is most suitable for them,” according to the statement, “However, more importantly, there needs to be a continued effort to ensure all women are adequately screened because a significant number of women in the country are not. It’s also essential for women to have access to all of the tests and that they are appropriately covered by insurance companies.

“We hope the USPSTF recommendations foster more discussions between patients and providers about cervical cancer screening, promote opportunities for patient education on the benefits and safety of HPV vaccination for cervical cancer prevention and encourage providers to offer HPV vaccines in their offices,” the statement noted.

The USPSTF research was funded by the Agency for Healthcare Research and Quality. The researchers for the modeling report were supported in part by a National Cancer Institute grant. The researchers had no relevant financial conflicts to disclose.

SOURCES: Kim J et al. JAMA. 2018 Aug 21. doi: 10.1001/jama.2017.19872; Melnikow J et al. JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10400; Curry S et al. JAMA. 2018 Aug 21. doi: 10.1001/jama.2018.10897.

The Food and Drug Administration has granted orphan drug designation to ASLAN003 as a treatment for acute myeloid leukemia (AML).

ASLAN003 is a small molecule inhibitor of the human dihydroorotate dehydrogenase (DHODH) enzyme. This second-generation DHODH inhibitor is being developed by Aslan Pharmaceuticals. The company is currently conducting a phase 2 trial (NCT03451084) of ASLAN003 in patients with newly diagnosed or relapsed/refractory AML. Aslan expects to report interim data from this trial in the second half of 2018.

Aslan has already completed a phase 1 trial (NCT01992367) of ASLAN003 in healthy volunteers. The results suggested that ASLAN003 has an “excellent” pharmacokinetic profile, according to Aslan, and the drug was considered well tolerated in the volunteers.

ASLAN003 has also demonstrated “potent” inhibition of DHODH, according to the drug sponsor. In fact, the company said the binding affinity of ASLAN003 to DHODH has proven to be up to two orders of magnitude stronger than first-generation DHODH inhibitors, such as leflunomide and teriflunomide, but it has less toxicity.

In addition, ASLAN003 has been shown to differentiate blast cells into granulocytes in AML cell lines that do not respond to all-trans retinoic acid. These results were published in Cell in 2016.

The Food and Drug Administration has granted orphan drug designation to ASLAN003 as a treatment for acute myeloid leukemia (AML).

ASLAN003 is a small molecule inhibitor of the human dihydroorotate dehydrogenase (DHODH) enzyme. This second-generation DHODH inhibitor is being developed by Aslan Pharmaceuticals. The company is currently conducting a phase 2 trial (NCT03451084) of ASLAN003 in patients with newly diagnosed or relapsed/refractory AML. Aslan expects to report interim data from this trial in the second half of 2018.

Aslan has already completed a phase 1 trial (NCT01992367) of ASLAN003 in healthy volunteers. The results suggested that ASLAN003 has an “excellent” pharmacokinetic profile, according to Aslan, and the drug was considered well tolerated in the volunteers.

ASLAN003 has also demonstrated “potent” inhibition of DHODH, according to the drug sponsor. In fact, the company said the binding affinity of ASLAN003 to DHODH has proven to be up to two orders of magnitude stronger than first-generation DHODH inhibitors, such as leflunomide and teriflunomide, but it has less toxicity.

In addition, ASLAN003 has been shown to differentiate blast cells into granulocytes in AML cell lines that do not respond to all-trans retinoic acid. These results were published in Cell in 2016.

The Food and Drug Administration has granted orphan drug designation to ASLAN003 as a treatment for acute myeloid leukemia (AML).

ASLAN003 is a small molecule inhibitor of the human dihydroorotate dehydrogenase (DHODH) enzyme. This second-generation DHODH inhibitor is being developed by Aslan Pharmaceuticals. The company is currently conducting a phase 2 trial (NCT03451084) of ASLAN003 in patients with newly diagnosed or relapsed/refractory AML. Aslan expects to report interim data from this trial in the second half of 2018.

Aslan has already completed a phase 1 trial (NCT01992367) of ASLAN003 in healthy volunteers. The results suggested that ASLAN003 has an “excellent” pharmacokinetic profile, according to Aslan, and the drug was considered well tolerated in the volunteers.

ASLAN003 has also demonstrated “potent” inhibition of DHODH, according to the drug sponsor. In fact, the company said the binding affinity of ASLAN003 to DHODH has proven to be up to two orders of magnitude stronger than first-generation DHODH inhibitors, such as leflunomide and teriflunomide, but it has less toxicity.

In addition, ASLAN003 has been shown to differentiate blast cells into granulocytes in AML cell lines that do not respond to all-trans retinoic acid. These results were published in Cell in 2016.

“You can teach a canary in a coal mine to meditate, but it is still going to die.”

I have seen the canary sentiment above – used as a metaphor for health care and burnout – pop up a few times on Twitter, attributed to a few different thoughtful doctors, including Jenny Ramsey, MD, of the Cleveland Clinic (at Hospital Medicine 2018); Lucy Kalanithi, MD, a clinical assistant professor of medicine at Stanford (Calif.) University and widow of Paul Kalanithi, MD, of “When Breath Becomes Air” fame; and Stuart Slavin, MD, associate dean for curriculum and a professor of pediatrics at Saint Louis University.

To be honest, I am rather burned out on reading about physician burnout at this point. Nevertheless, I love the canary idea; it is such a perfect visual of the current problem facing physicians.

I was thinking about the meditating canary when I read the new “Charter on Physician Well-Being,” published in JAMA and already endorsed by most major medical organizations/acronyms, including SHM, ACP, SGIM, AMA, AAMC, AAIM, ABIM, ACCME, APA, and the IHI. This physician well-being charter was created by the Collaborative for Healing and Renewal in Medicine, a group that includes leading medical centers and organizations.

What makes this different from previous attempts at addressing burnout? The charter takes a systems-based approach to physician well-being. Aha, of course! As the patient safety movement realized more than 2 decades ago, real progress would only be made when we stopped focusing our attention, blame, and interventions on individuals and instead looked at systems; now, the physician well-being movement has officially made the same bold proclamation.

It is not the fault of the burned-out physician who apparently just needs to be hammered over the head with better coping skills – just as the majority of medical errors would not be fixed by continuing to tell physicians that they screwed up and should figure out how not to do that again!

We need to make real changes to the system. For example, one of the charter’s authors, Colin P. West, MD, PhD, highlighted why it is important that organizations commit to optimizing highly functioning interprofessional teams: “Can you imagine @KingJames [LeBron James] or @Oprah applying their unique skills AND personally seating the crowd, collecting stats, assessing satisfaction, etc.? So why do we?”

The authors also call for organizations to commit to reducing time spent on documentation and administration. Hallelujah!

Now the question is whether this charter will actually have any teeth or whether it will have the same fate as our canary, slowly fading away, never to be heard from again?

Read the full post at hospitalleader.org.

Dr. Moriates is the assistant dean for health care value and an associate professor of internal medicine at the University of Texas, Austin.
 

Also in The Hospital Leader

“What’s a Cost, Charge, and Price?” by Brad Flansbaum, DO, MPH, MHM

“There Is a ‘You’ in Team,” by Tracy Cardin, ACNP-BC, SFHM

“‘Harper’s Index’ of Hospital Medicine 2018,” by Jordan Messler, MD, SFHM

“You can teach a canary in a coal mine to meditate, but it is still going to die.”

I have seen the canary sentiment above – used as a metaphor for health care and burnout – pop up a few times on Twitter, attributed to a few different thoughtful doctors, including Jenny Ramsey, MD, of the Cleveland Clinic (at Hospital Medicine 2018); Lucy Kalanithi, MD, a clinical assistant professor of medicine at Stanford (Calif.) University and widow of Paul Kalanithi, MD, of “When Breath Becomes Air” fame; and Stuart Slavin, MD, associate dean for curriculum and a professor of pediatrics at Saint Louis University.

To be honest, I am rather burned out on reading about physician burnout at this point. Nevertheless, I love the canary idea; it is such a perfect visual of the current problem facing physicians.

I was thinking about the meditating canary when I read the new “Charter on Physician Well-Being,” published in JAMA and already endorsed by most major medical organizations/acronyms, including SHM, ACP, SGIM, AMA, AAMC, AAIM, ABIM, ACCME, APA, and the IHI. This physician well-being charter was created by the Collaborative for Healing and Renewal in Medicine, a group that includes leading medical centers and organizations.

What makes this different from previous attempts at addressing burnout? The charter takes a systems-based approach to physician well-being. Aha, of course! As the patient safety movement realized more than 2 decades ago, real progress would only be made when we stopped focusing our attention, blame, and interventions on individuals and instead looked at systems; now, the physician well-being movement has officially made the same bold proclamation.

It is not the fault of the burned-out physician who apparently just needs to be hammered over the head with better coping skills – just as the majority of medical errors would not be fixed by continuing to tell physicians that they screwed up and should figure out how not to do that again!

We need to make real changes to the system. For example, one of the charter’s authors, Colin P. West, MD, PhD, highlighted why it is important that organizations commit to optimizing highly functioning interprofessional teams: “Can you imagine @KingJames [LeBron James] or @Oprah applying their unique skills AND personally seating the crowd, collecting stats, assessing satisfaction, etc.? So why do we?”

The authors also call for organizations to commit to reducing time spent on documentation and administration. Hallelujah!

Now the question is whether this charter will actually have any teeth or whether it will have the same fate as our canary, slowly fading away, never to be heard from again?

Read the full post at hospitalleader.org.

Dr. Moriates is the assistant dean for health care value and an associate professor of internal medicine at the University of Texas, Austin.
 

Also in The Hospital Leader

“What’s a Cost, Charge, and Price?” by Brad Flansbaum, DO, MPH, MHM

“There Is a ‘You’ in Team,” by Tracy Cardin, ACNP-BC, SFHM

“‘Harper’s Index’ of Hospital Medicine 2018,” by Jordan Messler, MD, SFHM

“You can teach a canary in a coal mine to meditate, but it is still going to die.”

I have seen the canary sentiment above – used as a metaphor for health care and burnout – pop up a few times on Twitter, attributed to a few different thoughtful doctors, including Jenny Ramsey, MD, of the Cleveland Clinic (at Hospital Medicine 2018); Lucy Kalanithi, MD, a clinical assistant professor of medicine at Stanford (Calif.) University and widow of Paul Kalanithi, MD, of “When Breath Becomes Air” fame; and Stuart Slavin, MD, associate dean for curriculum and a professor of pediatrics at Saint Louis University.

To be honest, I am rather burned out on reading about physician burnout at this point. Nevertheless, I love the canary idea; it is such a perfect visual of the current problem facing physicians.

I was thinking about the meditating canary when I read the new “Charter on Physician Well-Being,” published in JAMA and already endorsed by most major medical organizations/acronyms, including SHM, ACP, SGIM, AMA, AAMC, AAIM, ABIM, ACCME, APA, and the IHI. This physician well-being charter was created by the Collaborative for Healing and Renewal in Medicine, a group that includes leading medical centers and organizations.

What makes this different from previous attempts at addressing burnout? The charter takes a systems-based approach to physician well-being. Aha, of course! As the patient safety movement realized more than 2 decades ago, real progress would only be made when we stopped focusing our attention, blame, and interventions on individuals and instead looked at systems; now, the physician well-being movement has officially made the same bold proclamation.

It is not the fault of the burned-out physician who apparently just needs to be hammered over the head with better coping skills – just as the majority of medical errors would not be fixed by continuing to tell physicians that they screwed up and should figure out how not to do that again!

We need to make real changes to the system. For example, one of the charter’s authors, Colin P. West, MD, PhD, highlighted why it is important that organizations commit to optimizing highly functioning interprofessional teams: “Can you imagine @KingJames [LeBron James] or @Oprah applying their unique skills AND personally seating the crowd, collecting stats, assessing satisfaction, etc.? So why do we?”

The authors also call for organizations to commit to reducing time spent on documentation and administration. Hallelujah!

Now the question is whether this charter will actually have any teeth or whether it will have the same fate as our canary, slowly fading away, never to be heard from again?

Read the full post at hospitalleader.org.

Dr. Moriates is the assistant dean for health care value and an associate professor of internal medicine at the University of Texas, Austin.
 

Also in The Hospital Leader

“What’s a Cost, Charge, and Price?” by Brad Flansbaum, DO, MPH, MHM

“There Is a ‘You’ in Team,” by Tracy Cardin, ACNP-BC, SFHM

“‘Harper’s Index’ of Hospital Medicine 2018,” by Jordan Messler, MD, SFHM

The Diagnosis: Unilateral Nevoid Telangiectasia

Unilateral nevoid telangiectasia (UNT) is an uncommon, or perhaps underreported, cutaneous condition involving telangiectatic patches in a unilateral dermatomal or blaschkoid pattern.¹ The condition has been described as either congenital or acquired. Congenital UNT is thought to be a result of somatic mosaicism, whereby a mutation during embryogenesis leads to a distinct population of cells expressing the vascular malformation.¹ Congenital UNT has been associated with Becker nevus, which also is thought to be a result of somatic mosaicism, further providing evidence for this theory, though it is unclear whether this finding is incidental.² The acquired form often is associated with fluctuation of hormones, such as in pregnancy or with oral contraceptive initiation, as well as with hepatic disease as seen in our patient. However, there are many cases of acquired UNT with no implicated underlying disease, alcohol abuse, or hormonal changes, which calls into question if UNT is definitively an estrogen-related condition.³ One study demonstrated an increased level of estrogen and progesterone receptors in affected skin, which may have led to expression of the cutaneous changes at that site.⁴ More research is needed to elucidate this point, as other studies have not reproduced similar findings.

Congenital UNT occurs more commonly in males, whereas the acquired variant is seen more frequently in females. The third and fourth cervical dermatomes most often are involved.⁵ Most lesions persist without spontaneous resolution. Treatment options are limited and include pulsed dye laser treatment and makeup application to cover the telangiectatic patches. The main side effect seen with pulsed dye laser treatment is reversible pigmentary changes, with 1 report of textural skin change.⁶

A biopsy was deemed unnecessary for the clinical diagnosis in our patient because there was a clear explanation for the physical examination findings due to long-standing underlying liver disease. When biopsied, UNT characteristically demonstrates dilated dermal capillaries.⁵ Our patient elected not to pursue laser therapy but expressed interest in using makeup to camouflage the lesion.

The differential diagnosis includes acquired nevus flammeus, which typically is present on the face and often appears following mechanical or thermal trauma. Angioma serpiginosum most often occurs on the buttocks and legs as small red papules or puncta coalescing into a serpiginous linear arrangement. It often appears in childhood. Angiosarcoma is an aggressive malignancy that often occurs on the head and neck in elderly patients. It is associated with areas of long-standing lymphedema and often appears as a bruiselike lesion. Rosacea typically is not fixed in its clinical appearance and presents as transitory flushing of the head and neck with or without a history of acneform eruptions on the face. It typically is not unilateral.

The Diagnosis: Unilateral Nevoid Telangiectasia

Unilateral nevoid telangiectasia (UNT) is an uncommon, or perhaps underreported, cutaneous condition involving telangiectatic patches in a unilateral dermatomal or blaschkoid pattern.¹ The condition has been described as either congenital or acquired. Congenital UNT is thought to be a result of somatic mosaicism, whereby a mutation during embryogenesis leads to a distinct population of cells expressing the vascular malformation.¹ Congenital UNT has been associated with Becker nevus, which also is thought to be a result of somatic mosaicism, further providing evidence for this theory, though it is unclear whether this finding is incidental.² The acquired form often is associated with fluctuation of hormones, such as in pregnancy or with oral contraceptive initiation, as well as with hepatic disease as seen in our patient. However, there are many cases of acquired UNT with no implicated underlying disease, alcohol abuse, or hormonal changes, which calls into question if UNT is definitively an estrogen-related condition.³ One study demonstrated an increased level of estrogen and progesterone receptors in affected skin, which may have led to expression of the cutaneous changes at that site.⁴ More research is needed to elucidate this point, as other studies have not reproduced similar findings.

Congenital UNT occurs more commonly in males, whereas the acquired variant is seen more frequently in females. The third and fourth cervical dermatomes most often are involved.⁵ Most lesions persist without spontaneous resolution. Treatment options are limited and include pulsed dye laser treatment and makeup application to cover the telangiectatic patches. The main side effect seen with pulsed dye laser treatment is reversible pigmentary changes, with 1 report of textural skin change.⁶

A biopsy was deemed unnecessary for the clinical diagnosis in our patient because there was a clear explanation for the physical examination findings due to long-standing underlying liver disease. When biopsied, UNT characteristically demonstrates dilated dermal capillaries.⁵ Our patient elected not to pursue laser therapy but expressed interest in using makeup to camouflage the lesion.

The differential diagnosis includes acquired nevus flammeus, which typically is present on the face and often appears following mechanical or thermal trauma. Angioma serpiginosum most often occurs on the buttocks and legs as small red papules or puncta coalescing into a serpiginous linear arrangement. It often appears in childhood. Angiosarcoma is an aggressive malignancy that often occurs on the head and neck in elderly patients. It is associated with areas of long-standing lymphedema and often appears as a bruiselike lesion. Rosacea typically is not fixed in its clinical appearance and presents as transitory flushing of the head and neck with or without a history of acneform eruptions on the face. It typically is not unilateral.

The Diagnosis: Unilateral Nevoid Telangiectasia

Unilateral nevoid telangiectasia (UNT) is an uncommon, or perhaps underreported, cutaneous condition involving telangiectatic patches in a unilateral dermatomal or blaschkoid pattern.¹ The condition has been described as either congenital or acquired. Congenital UNT is thought to be a result of somatic mosaicism, whereby a mutation during embryogenesis leads to a distinct population of cells expressing the vascular malformation.¹ Congenital UNT has been associated with Becker nevus, which also is thought to be a result of somatic mosaicism, further providing evidence for this theory, though it is unclear whether this finding is incidental.² The acquired form often is associated with fluctuation of hormones, such as in pregnancy or with oral contraceptive initiation, as well as with hepatic disease as seen in our patient. However, there are many cases of acquired UNT with no implicated underlying disease, alcohol abuse, or hormonal changes, which calls into question if UNT is definitively an estrogen-related condition.³ One study demonstrated an increased level of estrogen and progesterone receptors in affected skin, which may have led to expression of the cutaneous changes at that site.⁴ More research is needed to elucidate this point, as other studies have not reproduced similar findings.

Congenital UNT occurs more commonly in males, whereas the acquired variant is seen more frequently in females. The third and fourth cervical dermatomes most often are involved.⁵ Most lesions persist without spontaneous resolution. Treatment options are limited and include pulsed dye laser treatment and makeup application to cover the telangiectatic patches. The main side effect seen with pulsed dye laser treatment is reversible pigmentary changes, with 1 report of textural skin change.⁶

A biopsy was deemed unnecessary for the clinical diagnosis in our patient because there was a clear explanation for the physical examination findings due to long-standing underlying liver disease. When biopsied, UNT characteristically demonstrates dilated dermal capillaries.⁵ Our patient elected not to pursue laser therapy but expressed interest in using makeup to camouflage the lesion.

The differential diagnosis includes acquired nevus flammeus, which typically is present on the face and often appears following mechanical or thermal trauma. Angioma serpiginosum most often occurs on the buttocks and legs as small red papules or puncta coalescing into a serpiginous linear arrangement. It often appears in childhood. Angiosarcoma is an aggressive malignancy that often occurs on the head and neck in elderly patients. It is associated with areas of long-standing lymphedema and often appears as a bruiselike lesion. Rosacea typically is not fixed in its clinical appearance and presents as transitory flushing of the head and neck with or without a history of acneform eruptions on the face. It typically is not unilateral.

A new study suggests that certain patients with acute pulmonary embolism (PE) may be better off receiving outpatient treatment.

Researchers tested outpatient anticoagulant therapy in 200 patients with PE with a low mortality risk. At 90 days of follow-up, there were no deaths or recurrences of venous thromboembolism (VTE), but one patient experienced major bleeding after a traumatic injury.

A majority of patients said they were satisfied with outpatient care.

Joseph R. Bledsoe, MD, of Intermountain Medical Center in Salt Lake City, and his colleagues reported these results in Chest.

The researchers tracked patients who were treated for acute PE in five Intermountain Healthcare emergency departments (EDs) from 2013 to 2016. The patients had to have a low mortality risk according to the Pulmonary Embolism Severity Index (score less than 86), echocardiography (no signs of right heart strain), and whole-leg compression ultrasound. Patients could not have deep vein thrombosis proximal to the popliteal vein, hypoxia, hypotension, hepatic failure, or renal failure. They had to be eligible for therapeutic anticoagulation and could not have any condition requiring hospitalization.

With these criteria, the researchers selected 200 patients. They were observed in the ED or hospital for 12-24 hours and then discharged with anticoagulant therapy. Patients received rivaroxaban (n = 149), enoxaparin transitioned to warfarin (n = 26), apixaban (n = 24), or enoxaparin alone (n = 1).

Results

The study’s primary outcome was the 90-day composite rate of all-cause mortality, recurrent symptomatic VTE, and major bleeding. There were no deaths and no cases of recurrent VTE, but one patient did experience major bleeding at day 61 because of a traumatic thigh injury.

Within 7 days of study enrollment, there were 19 patients (9.5%) who returned to the ED and 2 patients (1%) who were admitted to the hospital. One patient with pulmonary infarct was admitted for pain control (day 2); the other was admitted for an elective coronary intervention (day 7) because of a positive cardiac stress test.

Within 30 days, 32 patients (16%) returned to the ED, and 5 (3%) were admitted to the hospital for events unrelated to their PE.

The study also showed that patients were largely satisfied with outpatient care. Of the 146 patients who completed a satisfaction survey at 90 days, 89% said they would choose outpatient management if they had another PE in the future.

“We found a large subset of patients with blood clots who’d do well at home; in fact, who probably did better at home,” Dr. Bledsoe said. “When patients are sent home versus staying in the hospital, they’re at lower risk of getting another infection. It’s a lot less expensive, too.”

Currently, the standard of care in the United States for acute PE is hospitalization for all patients. That’s recommended, in part, because their overall mortality rate is 17%. However, the lower mortality rate among some appropriately risk-stratified patients suggests that at-home care, which has become the norm in some European countries, leads to better outcomes for those patients overall and less chance of a hospital-introduced infection, according to Dr. Bledsoe. “Our findings show that if you appropriately risk-stratify patients, there are a lot of people with blood clots who are safe to go home.”

He added that similar research should be conducted outside of the Intermountain Healthcare system to confirm the results of this study and that a larger group of patients should be studied.

The investigators reported no conflicts related to this study.

SOURCE: Bledsoe JR et al. Chest. 2018 Aug;154(2):249-56.

A new study suggests that certain patients with acute pulmonary embolism (PE) may be better off receiving outpatient treatment.

Researchers tested outpatient anticoagulant therapy in 200 patients with PE with a low mortality risk. At 90 days of follow-up, there were no deaths or recurrences of venous thromboembolism (VTE), but one patient experienced major bleeding after a traumatic injury.

A majority of patients said they were satisfied with outpatient care.

Joseph R. Bledsoe, MD, of Intermountain Medical Center in Salt Lake City, and his colleagues reported these results in Chest.

The researchers tracked patients who were treated for acute PE in five Intermountain Healthcare emergency departments (EDs) from 2013 to 2016. The patients had to have a low mortality risk according to the Pulmonary Embolism Severity Index (score less than 86), echocardiography (no signs of right heart strain), and whole-leg compression ultrasound. Patients could not have deep vein thrombosis proximal to the popliteal vein, hypoxia, hypotension, hepatic failure, or renal failure. They had to be eligible for therapeutic anticoagulation and could not have any condition requiring hospitalization.

With these criteria, the researchers selected 200 patients. They were observed in the ED or hospital for 12-24 hours and then discharged with anticoagulant therapy. Patients received rivaroxaban (n = 149), enoxaparin transitioned to warfarin (n = 26), apixaban (n = 24), or enoxaparin alone (n = 1).

Results

The study’s primary outcome was the 90-day composite rate of all-cause mortality, recurrent symptomatic VTE, and major bleeding. There were no deaths and no cases of recurrent VTE, but one patient did experience major bleeding at day 61 because of a traumatic thigh injury.

Within 7 days of study enrollment, there were 19 patients (9.5%) who returned to the ED and 2 patients (1%) who were admitted to the hospital. One patient with pulmonary infarct was admitted for pain control (day 2); the other was admitted for an elective coronary intervention (day 7) because of a positive cardiac stress test.

Within 30 days, 32 patients (16%) returned to the ED, and 5 (3%) were admitted to the hospital for events unrelated to their PE.

The study also showed that patients were largely satisfied with outpatient care. Of the 146 patients who completed a satisfaction survey at 90 days, 89% said they would choose outpatient management if they had another PE in the future.

“We found a large subset of patients with blood clots who’d do well at home; in fact, who probably did better at home,” Dr. Bledsoe said. “When patients are sent home versus staying in the hospital, they’re at lower risk of getting another infection. It’s a lot less expensive, too.”

Currently, the standard of care in the United States for acute PE is hospitalization for all patients. That’s recommended, in part, because their overall mortality rate is 17%. However, the lower mortality rate among some appropriately risk-stratified patients suggests that at-home care, which has become the norm in some European countries, leads to better outcomes for those patients overall and less chance of a hospital-introduced infection, according to Dr. Bledsoe. “Our findings show that if you appropriately risk-stratify patients, there are a lot of people with blood clots who are safe to go home.”

He added that similar research should be conducted outside of the Intermountain Healthcare system to confirm the results of this study and that a larger group of patients should be studied.

The investigators reported no conflicts related to this study.

SOURCE: Bledsoe JR et al. Chest. 2018 Aug;154(2):249-56.

A new study suggests that certain patients with acute pulmonary embolism (PE) may be better off receiving outpatient treatment.

Researchers tested outpatient anticoagulant therapy in 200 patients with PE with a low mortality risk. At 90 days of follow-up, there were no deaths or recurrences of venous thromboembolism (VTE), but one patient experienced major bleeding after a traumatic injury.

A majority of patients said they were satisfied with outpatient care.

Joseph R. Bledsoe, MD, of Intermountain Medical Center in Salt Lake City, and his colleagues reported these results in Chest.

The researchers tracked patients who were treated for acute PE in five Intermountain Healthcare emergency departments (EDs) from 2013 to 2016. The patients had to have a low mortality risk according to the Pulmonary Embolism Severity Index (score less than 86), echocardiography (no signs of right heart strain), and whole-leg compression ultrasound. Patients could not have deep vein thrombosis proximal to the popliteal vein, hypoxia, hypotension, hepatic failure, or renal failure. They had to be eligible for therapeutic anticoagulation and could not have any condition requiring hospitalization.

With these criteria, the researchers selected 200 patients. They were observed in the ED or hospital for 12-24 hours and then discharged with anticoagulant therapy. Patients received rivaroxaban (n = 149), enoxaparin transitioned to warfarin (n = 26), apixaban (n = 24), or enoxaparin alone (n = 1).

Results

The study’s primary outcome was the 90-day composite rate of all-cause mortality, recurrent symptomatic VTE, and major bleeding. There were no deaths and no cases of recurrent VTE, but one patient did experience major bleeding at day 61 because of a traumatic thigh injury.

Within 7 days of study enrollment, there were 19 patients (9.5%) who returned to the ED and 2 patients (1%) who were admitted to the hospital. One patient with pulmonary infarct was admitted for pain control (day 2); the other was admitted for an elective coronary intervention (day 7) because of a positive cardiac stress test.

Within 30 days, 32 patients (16%) returned to the ED, and 5 (3%) were admitted to the hospital for events unrelated to their PE.

The study also showed that patients were largely satisfied with outpatient care. Of the 146 patients who completed a satisfaction survey at 90 days, 89% said they would choose outpatient management if they had another PE in the future.

“We found a large subset of patients with blood clots who’d do well at home; in fact, who probably did better at home,” Dr. Bledsoe said. “When patients are sent home versus staying in the hospital, they’re at lower risk of getting another infection. It’s a lot less expensive, too.”

Currently, the standard of care in the United States for acute PE is hospitalization for all patients. That’s recommended, in part, because their overall mortality rate is 17%. However, the lower mortality rate among some appropriately risk-stratified patients suggests that at-home care, which has become the norm in some European countries, leads to better outcomes for those patients overall and less chance of a hospital-introduced infection, according to Dr. Bledsoe. “Our findings show that if you appropriately risk-stratify patients, there are a lot of people with blood clots who are safe to go home.”

He added that similar research should be conducted outside of the Intermountain Healthcare system to confirm the results of this study and that a larger group of patients should be studied.

The investigators reported no conflicts related to this study.

SOURCE: Bledsoe JR et al. Chest. 2018 Aug;154(2):249-56.

Over the past several months, I’ve found myself increasingly reflective on the intersection of culture, relationships, and my professional work with those who have an autism spectrum disorder. Last winter, an adolescent boy treated by myself and other providers died by suicide. Adam (name changed) had been diagnosed with autism as a toddler and had struggled with anxiety and depression for several years; in the office, as he grew into an athletic teenager, Adam spoke more frequently about “not fitting in” with his peers and therapeutic focus was placed on building Adam’s sense of himself and fostering his self-confidence and perceived self-competence. His unexpected death was a tremendous shock, and his loved ones – including the clinical team – desperately searched for answers that could help add some understanding to the heartbreaking event.

Rawpixel/Thinkstock

As I attempted to search for answers and reconcile national news with my clinical and teaching experiences, I was struck by something that Andrew Solomon eloquently captured in his June 2018 New Yorker article that again touches upon the theme of connection.⁶ Mr. Solomon writes “modernity is alienating” and about how he receives correspondence from those who struggle with depression. “What is most striking to me is how alone many of them are ... these people are so alone that they are effectively invisible to the rest of us ... many of them describe suicidal feelings,” he noted.

The power of connection in our day-to-day work is undeniable. The influence of human interaction and appreciating one’s unique narrative is a bedrock of clinical care and can unquestionably allow us to better understand individual suffering, deliver optimal care, and combat shame as Hannah Gadsby boldly shared in her recent Netflix comedy special “Nanette.” This shame can drive one to experience earth-shattering depressive episodes and influence thoughts of suicide. “We simply cannot make it on our own,” Ms. Gadsby explains, “we’re humans. We’re to be connected.” Humans are indeed hardwired for connection; isolation and disconnection can lead to significant health problems and are linked with mental health concerns. The former U.S. Surgeon General Vivek H. Murthy, MD, has referred to loneliness as an epidemic, and those with autism may be at increased risk for feeling lonely and isolated.^7,8

Synthesizing thoughts about relationships, suicide, loneliness, love, well-being, and autism produces a complicated web of, well, connections. Suicide in the autism population hasn’t been well researched, but one 2016 study revealed sobering numbers about suicide being a leading cause of premature death in people with autism.⁹ How do these numbers associate with feelings of isolation, wanting to fit in, and troubles talking about emotions – all of which can characterize those with ASD? Data, not surprisingly, support the role of loneliness as a risk factor for the development of depression and suicidal ideation in those with ASD.¹⁰ In addition, social-communication challenges, even in the absence of an autism diagnosis, are related to depression and suicidality.¹¹ Another recent study showed a relationship between autistic traits and depression symptoms, an association seemingly linked to being bullied.¹² We cannot continue to hold onto the myth that individuals with autism don’t desire relationships and love because it’s these desires and not being able to fulfill them, limited opportunities to engage in meaningful experiences, and feeling different that can lead to negative outcomes.

Dr. Dickerson, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington, where he is director of the autism diagnostic clinic. Email him at [email protected].

References

1. Harv Rev Psychiatry. 2018 Jul/Aug;26(4):201-15.

2. MMWR Morb Mortal Wkly Rep. 2018 Jun 8;67(22):617-24.

3. www.healthvermont.gov/YRBS

4. MMWR Surveill Summ. 2017 Oct;66(18):1-16.

5. JAMA Pediatr. 2015 May;169(5):466-73.

6. “Anthony Bourdain, Kate Spade, and the Preventable Tragedies of Suicide,” By Anthony Solomon, The New Yorker. Jun 8, 2018.

7. “Work and the Loneliness Epidemic,” By Vivek H. Murthy, Harvard Business Review. Sep 28, 2017.

8. Child Dev. 2000 Mar-Apr;71(2):447-56.

9. Br J Psychiatry. 2016 Mar;208(3):232-8.

10. Depress Anxiety. 2018 Jul;35(7):648-57.

11. J Am Acad Child Adolesc Psychiatry. 2018 May;57(5):313-20.

12. JAMA Psychiatry. 2018 Aug 1;75(8):835-43.

13. The Lancet Psychiatry. 2017 Jun;4(6):e11.

14. “Promoting Individual, Family, and Community Connectedness to Prevent Suicidal Behavior,” Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, www.cdc.gov/injury.

15. JAMA Psychiatry. 2018 Jul 11. doi: 10.1001/jamapsychiatry.2018.1776.

Over the past several months, I’ve found myself increasingly reflective on the intersection of culture, relationships, and my professional work with those who have an autism spectrum disorder. Last winter, an adolescent boy treated by myself and other providers died by suicide. Adam (name changed) had been diagnosed with autism as a toddler and had struggled with anxiety and depression for several years; in the office, as he grew into an athletic teenager, Adam spoke more frequently about “not fitting in” with his peers and therapeutic focus was placed on building Adam’s sense of himself and fostering his self-confidence and perceived self-competence. His unexpected death was a tremendous shock, and his loved ones – including the clinical team – desperately searched for answers that could help add some understanding to the heartbreaking event.

Rawpixel/Thinkstock

As I attempted to search for answers and reconcile national news with my clinical and teaching experiences, I was struck by something that Andrew Solomon eloquently captured in his June 2018 New Yorker article that again touches upon the theme of connection.⁶ Mr. Solomon writes “modernity is alienating” and about how he receives correspondence from those who struggle with depression. “What is most striking to me is how alone many of them are ... these people are so alone that they are effectively invisible to the rest of us ... many of them describe suicidal feelings,” he noted.

The power of connection in our day-to-day work is undeniable. The influence of human interaction and appreciating one’s unique narrative is a bedrock of clinical care and can unquestionably allow us to better understand individual suffering, deliver optimal care, and combat shame as Hannah Gadsby boldly shared in her recent Netflix comedy special “Nanette.” This shame can drive one to experience earth-shattering depressive episodes and influence thoughts of suicide. “We simply cannot make it on our own,” Ms. Gadsby explains, “we’re humans. We’re to be connected.” Humans are indeed hardwired for connection; isolation and disconnection can lead to significant health problems and are linked with mental health concerns. The former U.S. Surgeon General Vivek H. Murthy, MD, has referred to loneliness as an epidemic, and those with autism may be at increased risk for feeling lonely and isolated.^7,8

Synthesizing thoughts about relationships, suicide, loneliness, love, well-being, and autism produces a complicated web of, well, connections. Suicide in the autism population hasn’t been well researched, but one 2016 study revealed sobering numbers about suicide being a leading cause of premature death in people with autism.⁹ How do these numbers associate with feelings of isolation, wanting to fit in, and troubles talking about emotions – all of which can characterize those with ASD? Data, not surprisingly, support the role of loneliness as a risk factor for the development of depression and suicidal ideation in those with ASD.¹⁰ In addition, social-communication challenges, even in the absence of an autism diagnosis, are related to depression and suicidality.¹¹ Another recent study showed a relationship between autistic traits and depression symptoms, an association seemingly linked to being bullied.¹² We cannot continue to hold onto the myth that individuals with autism don’t desire relationships and love because it’s these desires and not being able to fulfill them, limited opportunities to engage in meaningful experiences, and feeling different that can lead to negative outcomes.

Dr. Dickerson, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington, where he is director of the autism diagnostic clinic. Email him at [email protected].

References

1. Harv Rev Psychiatry. 2018 Jul/Aug;26(4):201-15.

2. MMWR Morb Mortal Wkly Rep. 2018 Jun 8;67(22):617-24.

3. www.healthvermont.gov/YRBS

4. MMWR Surveill Summ. 2017 Oct;66(18):1-16.

5. JAMA Pediatr. 2015 May;169(5):466-73.

6. “Anthony Bourdain, Kate Spade, and the Preventable Tragedies of Suicide,” By Anthony Solomon, The New Yorker. Jun 8, 2018.

7. “Work and the Loneliness Epidemic,” By Vivek H. Murthy, Harvard Business Review. Sep 28, 2017.

8. Child Dev. 2000 Mar-Apr;71(2):447-56.

9. Br J Psychiatry. 2016 Mar;208(3):232-8.

10. Depress Anxiety. 2018 Jul;35(7):648-57.

11. J Am Acad Child Adolesc Psychiatry. 2018 May;57(5):313-20.

12. JAMA Psychiatry. 2018 Aug 1;75(8):835-43.

13. The Lancet Psychiatry. 2017 Jun;4(6):e11.

14. “Promoting Individual, Family, and Community Connectedness to Prevent Suicidal Behavior,” Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, www.cdc.gov/injury.

15. JAMA Psychiatry. 2018 Jul 11. doi: 10.1001/jamapsychiatry.2018.1776.

Over the past several months, I’ve found myself increasingly reflective on the intersection of culture, relationships, and my professional work with those who have an autism spectrum disorder. Last winter, an adolescent boy treated by myself and other providers died by suicide. Adam (name changed) had been diagnosed with autism as a toddler and had struggled with anxiety and depression for several years; in the office, as he grew into an athletic teenager, Adam spoke more frequently about “not fitting in” with his peers and therapeutic focus was placed on building Adam’s sense of himself and fostering his self-confidence and perceived self-competence. His unexpected death was a tremendous shock, and his loved ones – including the clinical team – desperately searched for answers that could help add some understanding to the heartbreaking event.

Rawpixel/Thinkstock

As I attempted to search for answers and reconcile national news with my clinical and teaching experiences, I was struck by something that Andrew Solomon eloquently captured in his June 2018 New Yorker article that again touches upon the theme of connection.⁶ Mr. Solomon writes “modernity is alienating” and about how he receives correspondence from those who struggle with depression. “What is most striking to me is how alone many of them are ... these people are so alone that they are effectively invisible to the rest of us ... many of them describe suicidal feelings,” he noted.

The power of connection in our day-to-day work is undeniable. The influence of human interaction and appreciating one’s unique narrative is a bedrock of clinical care and can unquestionably allow us to better understand individual suffering, deliver optimal care, and combat shame as Hannah Gadsby boldly shared in her recent Netflix comedy special “Nanette.” This shame can drive one to experience earth-shattering depressive episodes and influence thoughts of suicide. “We simply cannot make it on our own,” Ms. Gadsby explains, “we’re humans. We’re to be connected.” Humans are indeed hardwired for connection; isolation and disconnection can lead to significant health problems and are linked with mental health concerns. The former U.S. Surgeon General Vivek H. Murthy, MD, has referred to loneliness as an epidemic, and those with autism may be at increased risk for feeling lonely and isolated.^7,8

Synthesizing thoughts about relationships, suicide, loneliness, love, well-being, and autism produces a complicated web of, well, connections. Suicide in the autism population hasn’t been well researched, but one 2016 study revealed sobering numbers about suicide being a leading cause of premature death in people with autism.⁹ How do these numbers associate with feelings of isolation, wanting to fit in, and troubles talking about emotions – all of which can characterize those with ASD? Data, not surprisingly, support the role of loneliness as a risk factor for the development of depression and suicidal ideation in those with ASD.¹⁰ In addition, social-communication challenges, even in the absence of an autism diagnosis, are related to depression and suicidality.¹¹ Another recent study showed a relationship between autistic traits and depression symptoms, an association seemingly linked to being bullied.¹² We cannot continue to hold onto the myth that individuals with autism don’t desire relationships and love because it’s these desires and not being able to fulfill them, limited opportunities to engage in meaningful experiences, and feeling different that can lead to negative outcomes.

Dr. Dickerson, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington, where he is director of the autism diagnostic clinic. Email him at [email protected].

References

1. Harv Rev Psychiatry. 2018 Jul/Aug;26(4):201-15.

2. MMWR Morb Mortal Wkly Rep. 2018 Jun 8;67(22):617-24.

3. www.healthvermont.gov/YRBS

4. MMWR Surveill Summ. 2017 Oct;66(18):1-16.

5. JAMA Pediatr. 2015 May;169(5):466-73.

6. “Anthony Bourdain, Kate Spade, and the Preventable Tragedies of Suicide,” By Anthony Solomon, The New Yorker. Jun 8, 2018.

7. “Work and the Loneliness Epidemic,” By Vivek H. Murthy, Harvard Business Review. Sep 28, 2017.

8. Child Dev. 2000 Mar-Apr;71(2):447-56.

9. Br J Psychiatry. 2016 Mar;208(3):232-8.

10. Depress Anxiety. 2018 Jul;35(7):648-57.

11. J Am Acad Child Adolesc Psychiatry. 2018 May;57(5):313-20.

12. JAMA Psychiatry. 2018 Aug 1;75(8):835-43.

13. The Lancet Psychiatry. 2017 Jun;4(6):e11.

14. “Promoting Individual, Family, and Community Connectedness to Prevent Suicidal Behavior,” Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, www.cdc.gov/injury.

15. JAMA Psychiatry. 2018 Jul 11. doi: 10.1001/jamapsychiatry.2018.1776.

WASHINGTON – Pediatric patients who received interdisciplinary outpatient care for sickle cell disease–related chronic pain experienced a reduction in average length of stay for pain-related hospitalizations, according to an exploratory analysis of patient outcomes at a single center.

Dr_Microbe/Thinkstock

Experiences at Children’s Mercy Hospital in Kansas City, Mo., have added to the body of evidence supporting integrative care for sickle cell disease (SCD) pain, Derrick L. Goubeaux, DO, said during an interview at the annual symposium of the Foundation for Sickle Cell Disease Research.

With time, chronic pain can become an overlay on pain from vasoocclusive crises as patients with SCD age, shifting the way that patients and providers think about pain, said Dr. Goubeaux, a pediatric hematology/oncology fellow at Children’s Mercy Hospital in Kansas City.

Using a collaborative approach that pulls in psychologists, social workers, and pain management specialists, the hospital’s multidisciplinary Sickle Cell Integrated Pain Program (SCIPP) seeks to optimize pain control by adding nonpharmacologic measures to medications, he said.

Dr. Goubeaux and his colleagues conducted a retrospective chart review that looked at individuals who received care from, or were referred to, the institution’s SCD program. Included in the study were patients who received care for SCD for at least 2 years before their referral to the SCIPP clinic, so that investigators could compare care for those patients before and after SCIPP clinic integration. The study also included patients who had not yet been integrated into SCIPP clinic care, for comparison.

Though the seven patients who were integrated into the SCIPP clinic did not have fewer hospitalizations than the five who were not referred, average length of stay (LOS) for the SCIPP patients dropped from 11 days to 8 days. Mean LOS also decreased for the non-SCIPP patients, from 7.4 to 5.8 days. The number of admissions per month for both groups increased over the study period, from a mean of 0.41 to 0.84 admissions per month for SCIPP patients, and from 0.27 to 0.43 for non-SCIPP patients.

The patients, who ranged in age from 138 to 253 months, mostly had HbSS SCD, but HbSbeta₀, HbSD, and HbSC patients were also included. Four patients in the SCIPP group and two of the non-SCIPP patients were taking hydroxyurea.

Noting that data collection is still in the early stages, Dr. Goubeaux and his collaborators observed that “the LOS has shortened by 3 days in the integrated group, compared to 1.6 days in the [non-SCIPP] group.” They are currently also investigating whether costs per admission and admission-associated opioid use differs for patients integrated into the SCIPP clinic.

Aside from the small number of patients studied, Dr. Goubeaux and his colleagues acknowledged that even non-SCIPP patients are likely to have had pain management and psychology consultations during their inpatient stays – and these consults are conducted by SCIPP-associated providers.

Dr. Goubeaux reported no relevant disclosures or outside sources of funding.

[email protected]

WASHINGTON – Pediatric patients who received interdisciplinary outpatient care for sickle cell disease–related chronic pain experienced a reduction in average length of stay for pain-related hospitalizations, according to an exploratory analysis of patient outcomes at a single center.

Dr_Microbe/Thinkstock

Experiences at Children’s Mercy Hospital in Kansas City, Mo., have added to the body of evidence supporting integrative care for sickle cell disease (SCD) pain, Derrick L. Goubeaux, DO, said during an interview at the annual symposium of the Foundation for Sickle Cell Disease Research.

With time, chronic pain can become an overlay on pain from vasoocclusive crises as patients with SCD age, shifting the way that patients and providers think about pain, said Dr. Goubeaux, a pediatric hematology/oncology fellow at Children’s Mercy Hospital in Kansas City.

Using a collaborative approach that pulls in psychologists, social workers, and pain management specialists, the hospital’s multidisciplinary Sickle Cell Integrated Pain Program (SCIPP) seeks to optimize pain control by adding nonpharmacologic measures to medications, he said.

Dr. Goubeaux and his colleagues conducted a retrospective chart review that looked at individuals who received care from, or were referred to, the institution’s SCD program. Included in the study were patients who received care for SCD for at least 2 years before their referral to the SCIPP clinic, so that investigators could compare care for those patients before and after SCIPP clinic integration. The study also included patients who had not yet been integrated into SCIPP clinic care, for comparison.

Though the seven patients who were integrated into the SCIPP clinic did not have fewer hospitalizations than the five who were not referred, average length of stay (LOS) for the SCIPP patients dropped from 11 days to 8 days. Mean LOS also decreased for the non-SCIPP patients, from 7.4 to 5.8 days. The number of admissions per month for both groups increased over the study period, from a mean of 0.41 to 0.84 admissions per month for SCIPP patients, and from 0.27 to 0.43 for non-SCIPP patients.

The patients, who ranged in age from 138 to 253 months, mostly had HbSS SCD, but HbSbeta₀, HbSD, and HbSC patients were also included. Four patients in the SCIPP group and two of the non-SCIPP patients were taking hydroxyurea.

Noting that data collection is still in the early stages, Dr. Goubeaux and his collaborators observed that “the LOS has shortened by 3 days in the integrated group, compared to 1.6 days in the [non-SCIPP] group.” They are currently also investigating whether costs per admission and admission-associated opioid use differs for patients integrated into the SCIPP clinic.

Aside from the small number of patients studied, Dr. Goubeaux and his colleagues acknowledged that even non-SCIPP patients are likely to have had pain management and psychology consultations during their inpatient stays – and these consults are conducted by SCIPP-associated providers.

Dr. Goubeaux reported no relevant disclosures or outside sources of funding.

[email protected]

WASHINGTON – Pediatric patients who received interdisciplinary outpatient care for sickle cell disease–related chronic pain experienced a reduction in average length of stay for pain-related hospitalizations, according to an exploratory analysis of patient outcomes at a single center.

Dr_Microbe/Thinkstock

Experiences at Children’s Mercy Hospital in Kansas City, Mo., have added to the body of evidence supporting integrative care for sickle cell disease (SCD) pain, Derrick L. Goubeaux, DO, said during an interview at the annual symposium of the Foundation for Sickle Cell Disease Research.

With time, chronic pain can become an overlay on pain from vasoocclusive crises as patients with SCD age, shifting the way that patients and providers think about pain, said Dr. Goubeaux, a pediatric hematology/oncology fellow at Children’s Mercy Hospital in Kansas City.

Using a collaborative approach that pulls in psychologists, social workers, and pain management specialists, the hospital’s multidisciplinary Sickle Cell Integrated Pain Program (SCIPP) seeks to optimize pain control by adding nonpharmacologic measures to medications, he said.

Dr. Goubeaux and his colleagues conducted a retrospective chart review that looked at individuals who received care from, or were referred to, the institution’s SCD program. Included in the study were patients who received care for SCD for at least 2 years before their referral to the SCIPP clinic, so that investigators could compare care for those patients before and after SCIPP clinic integration. The study also included patients who had not yet been integrated into SCIPP clinic care, for comparison.

Though the seven patients who were integrated into the SCIPP clinic did not have fewer hospitalizations than the five who were not referred, average length of stay (LOS) for the SCIPP patients dropped from 11 days to 8 days. Mean LOS also decreased for the non-SCIPP patients, from 7.4 to 5.8 days. The number of admissions per month for both groups increased over the study period, from a mean of 0.41 to 0.84 admissions per month for SCIPP patients, and from 0.27 to 0.43 for non-SCIPP patients.

The patients, who ranged in age from 138 to 253 months, mostly had HbSS SCD, but HbSbeta₀, HbSD, and HbSC patients were also included. Four patients in the SCIPP group and two of the non-SCIPP patients were taking hydroxyurea.

Noting that data collection is still in the early stages, Dr. Goubeaux and his collaborators observed that “the LOS has shortened by 3 days in the integrated group, compared to 1.6 days in the [non-SCIPP] group.” They are currently also investigating whether costs per admission and admission-associated opioid use differs for patients integrated into the SCIPP clinic.

Aside from the small number of patients studied, Dr. Goubeaux and his colleagues acknowledged that even non-SCIPP patients are likely to have had pain management and psychology consultations during their inpatient stays – and these consults are conducted by SCIPP-associated providers.

Dr. Goubeaux reported no relevant disclosures or outside sources of funding.

[email protected]