The Food and Drug Administration has granted accelerated approval to avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) in adult and pediatric patients aged 12 years and older.

Avelumab, a programmed death-ligand 1 (PD-L1)–blocking human IgG1 lambda monoclonal antibody, is the first FDA-approved treatment for metastatic MCC.

Approval was based on a 33% overall response rate in a single arm trial (JAVELIN Merkel 200 trial) of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen, the FDA said in a written statement.

The response duration among that 33% ranged from 2.8 to 23.3+ months, and 86% of responses were durable for 6 months or more. “Responses were observed in patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus,” the FDA said.

There were safety data in 1,738 patients, who received 10 mg/kg of avelumab every 2 weeks. Immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus, and nephritis) and life-threatening infusion reactions were the most common, serious adverse events associated with avelumab. Of the 88 patients in the JAVELIN Merkel 200 trial, the most common adverse reactions were fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema. Serious adverse reactions that occurred in more than one patient in the trial were acute kidney injury, anemia, abdominal pain, ileus, asthenia, and cellulitis, the FDA said.

The recommended dose of avelumab is 10 mg/kg administered in an intravenous infusion over 60 minutes every 2 weeks. Labeling includes the recommendation that all patients should be premedicated with an antihistamine and acetaminophen before each of the first four infusions.

“As a condition of accelerated approval, an additional study is required to confirm the clinical benefit of avelumab for this indication,” according to the FDA.

The drug is being marketed as Bavencio by EMD Serono.

[email protected]
 

The Food and Drug Administration has granted accelerated approval to avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) in adult and pediatric patients aged 12 years and older.

Avelumab, a programmed death-ligand 1 (PD-L1)–blocking human IgG1 lambda monoclonal antibody, is the first FDA-approved treatment for metastatic MCC.

Approval was based on a 33% overall response rate in a single arm trial (JAVELIN Merkel 200 trial) of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen, the FDA said in a written statement.

The response duration among that 33% ranged from 2.8 to 23.3+ months, and 86% of responses were durable for 6 months or more. “Responses were observed in patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus,” the FDA said.

There were safety data in 1,738 patients, who received 10 mg/kg of avelumab every 2 weeks. Immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus, and nephritis) and life-threatening infusion reactions were the most common, serious adverse events associated with avelumab. Of the 88 patients in the JAVELIN Merkel 200 trial, the most common adverse reactions were fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema. Serious adverse reactions that occurred in more than one patient in the trial were acute kidney injury, anemia, abdominal pain, ileus, asthenia, and cellulitis, the FDA said.

The recommended dose of avelumab is 10 mg/kg administered in an intravenous infusion over 60 minutes every 2 weeks. Labeling includes the recommendation that all patients should be premedicated with an antihistamine and acetaminophen before each of the first four infusions.

“As a condition of accelerated approval, an additional study is required to confirm the clinical benefit of avelumab for this indication,” according to the FDA.

The drug is being marketed as Bavencio by EMD Serono.

[email protected]
 

The Food and Drug Administration has granted accelerated approval to avelumab for the treatment of metastatic Merkel cell carcinoma (MCC) in adult and pediatric patients aged 12 years and older.

Avelumab, a programmed death-ligand 1 (PD-L1)–blocking human IgG1 lambda monoclonal antibody, is the first FDA-approved treatment for metastatic MCC.

Approval was based on a 33% overall response rate in a single arm trial (JAVELIN Merkel 200 trial) of 88 patients with metastatic MCC who had been previously treated with at least one prior chemotherapy regimen, the FDA said in a written statement.

The response duration among that 33% ranged from 2.8 to 23.3+ months, and 86% of responses were durable for 6 months or more. “Responses were observed in patients regardless of PD-L1 tumor expression or presence of Merkel cell polyomavirus,” the FDA said.

There were safety data in 1,738 patients, who received 10 mg/kg of avelumab every 2 weeks. Immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, adrenal insufficiency, hypo- and hyperthyroidism, diabetes mellitus, and nephritis) and life-threatening infusion reactions were the most common, serious adverse events associated with avelumab. Of the 88 patients in the JAVELIN Merkel 200 trial, the most common adverse reactions were fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema. Serious adverse reactions that occurred in more than one patient in the trial were acute kidney injury, anemia, abdominal pain, ileus, asthenia, and cellulitis, the FDA said.

The recommended dose of avelumab is 10 mg/kg administered in an intravenous infusion over 60 minutes every 2 weeks. Labeling includes the recommendation that all patients should be premedicated with an antihistamine and acetaminophen before each of the first four infusions.

“As a condition of accelerated approval, an additional study is required to confirm the clinical benefit of avelumab for this indication,” according to the FDA.

The drug is being marketed as Bavencio by EMD Serono.

[email protected]
 

Family members other than parents can play a key role in initial recognition of problems prior to diagnosis of autism, which may lead to earlier diagnosis and potentially better outcomes, a study found.

Of 477 parents of children with autism who were surveyed online, 25% of parents reported that other individuals indicated their child might have a serious condition before they themselves suspected it. “The two most common categories of individuals are maternal grandmothers (27%) and teachers (24%),” Nachum Sicherman, PhD, of Columbia Business School, New York, and associates said. “If one adds maternal and paternal grandmothers and grandfathers together, then 59% of respondents who reported that anyone had raised concerns before they were aware that their child had a problem identified grandparents as having done so” (Autism. 2017. doi: 10.1177/1362361316679632)”

MattZ90/Thinkstockphotos.com

[email protected]

*This article was update 3/27/2018

Family members other than parents can play a key role in initial recognition of problems prior to diagnosis of autism, which may lead to earlier diagnosis and potentially better outcomes, a study found.

Of 477 parents of children with autism who were surveyed online, 25% of parents reported that other individuals indicated their child might have a serious condition before they themselves suspected it. “The two most common categories of individuals are maternal grandmothers (27%) and teachers (24%),” Nachum Sicherman, PhD, of Columbia Business School, New York, and associates said. “If one adds maternal and paternal grandmothers and grandfathers together, then 59% of respondents who reported that anyone had raised concerns before they were aware that their child had a problem identified grandparents as having done so” (Autism. 2017. doi: 10.1177/1362361316679632)”

MattZ90/Thinkstockphotos.com

[email protected]

*This article was update 3/27/2018

Family members other than parents can play a key role in initial recognition of problems prior to diagnosis of autism, which may lead to earlier diagnosis and potentially better outcomes, a study found.

Of 477 parents of children with autism who were surveyed online, 25% of parents reported that other individuals indicated their child might have a serious condition before they themselves suspected it. “The two most common categories of individuals are maternal grandmothers (27%) and teachers (24%),” Nachum Sicherman, PhD, of Columbia Business School, New York, and associates said. “If one adds maternal and paternal grandmothers and grandfathers together, then 59% of respondents who reported that anyone had raised concerns before they were aware that their child had a problem identified grandparents as having done so” (Autism. 2017. doi: 10.1177/1362361316679632)”

MattZ90/Thinkstockphotos.com

[email protected]

*This article was update 3/27/2018

ATLANTA – About a third to half of patients who test negative for penicillin allergies and have the label removed from their charts will, somewhere down the line, be relabeled as penicillin allergic.

It’s a vexing problem for the increasing number of patients who undergo confirmatory skin testing for penicillin sensitivity while in hospital. It’s become clear in recent years that at least 90% of people who say they have a penicillin allergy don’t really have one. Without confirmatory testing, they end up on expensive, second-line antibiotics, and don’t do well.

It’s unclear why people are relabeled after negative tests. Maybe patients don’t trust the results. Maybe doctors don’t hear about them or err on the side of caution despite negative testing. “I suspect it’s a combination of patient and provider factors,” said Sheenal Patel, MD, an allergy and immunology fellow at the University of Texas Southwestern Medical Center, Dallas.

[email protected]

ATLANTA – About a third to half of patients who test negative for penicillin allergies and have the label removed from their charts will, somewhere down the line, be relabeled as penicillin allergic.

It’s a vexing problem for the increasing number of patients who undergo confirmatory skin testing for penicillin sensitivity while in hospital. It’s become clear in recent years that at least 90% of people who say they have a penicillin allergy don’t really have one. Without confirmatory testing, they end up on expensive, second-line antibiotics, and don’t do well.

It’s unclear why people are relabeled after negative tests. Maybe patients don’t trust the results. Maybe doctors don’t hear about them or err on the side of caution despite negative testing. “I suspect it’s a combination of patient and provider factors,” said Sheenal Patel, MD, an allergy and immunology fellow at the University of Texas Southwestern Medical Center, Dallas.

[email protected]

ATLANTA – About a third to half of patients who test negative for penicillin allergies and have the label removed from their charts will, somewhere down the line, be relabeled as penicillin allergic.

It’s a vexing problem for the increasing number of patients who undergo confirmatory skin testing for penicillin sensitivity while in hospital. It’s become clear in recent years that at least 90% of people who say they have a penicillin allergy don’t really have one. Without confirmatory testing, they end up on expensive, second-line antibiotics, and don’t do well.

It’s unclear why people are relabeled after negative tests. Maybe patients don’t trust the results. Maybe doctors don’t hear about them or err on the side of caution despite negative testing. “I suspect it’s a combination of patient and provider factors,” said Sheenal Patel, MD, an allergy and immunology fellow at the University of Texas Southwestern Medical Center, Dallas.

[email protected]

WASHINGTON – In what could prove to be the final word in the clinical controversy over the safety of prescribing digoxin in patients with atrial fibrillation, a secondary analysis of the roughly 18,000-patient ARISTOTLE trial has come down emphatically on the side of avoiding the venerable drug.

“The clinical implications of our analysis are that in the absence of randomized trial data showing its safety and efficacy, digoxin should generally not be prescribed for patients with atrial fibrillation, particularly if symptoms can be alleviated with other treatments. And in patients with atrial fibrillation already taking digoxin, monitoring its serum concentration may be important, targeting blood levels below 1.2 ng/mL,” Renato D. Lopes, MD, PhD, said at the annual meeting of the American College of Cardiology.

Bruce Jancin/Frontline Medical News

[email protected]

WASHINGTON – In what could prove to be the final word in the clinical controversy over the safety of prescribing digoxin in patients with atrial fibrillation, a secondary analysis of the roughly 18,000-patient ARISTOTLE trial has come down emphatically on the side of avoiding the venerable drug.

“The clinical implications of our analysis are that in the absence of randomized trial data showing its safety and efficacy, digoxin should generally not be prescribed for patients with atrial fibrillation, particularly if symptoms can be alleviated with other treatments. And in patients with atrial fibrillation already taking digoxin, monitoring its serum concentration may be important, targeting blood levels below 1.2 ng/mL,” Renato D. Lopes, MD, PhD, said at the annual meeting of the American College of Cardiology.

Bruce Jancin/Frontline Medical News

[email protected]

WASHINGTON – In what could prove to be the final word in the clinical controversy over the safety of prescribing digoxin in patients with atrial fibrillation, a secondary analysis of the roughly 18,000-patient ARISTOTLE trial has come down emphatically on the side of avoiding the venerable drug.

“The clinical implications of our analysis are that in the absence of randomized trial data showing its safety and efficacy, digoxin should generally not be prescribed for patients with atrial fibrillation, particularly if symptoms can be alleviated with other treatments. And in patients with atrial fibrillation already taking digoxin, monitoring its serum concentration may be important, targeting blood levels below 1.2 ng/mL,” Renato D. Lopes, MD, PhD, said at the annual meeting of the American College of Cardiology.

Bruce Jancin/Frontline Medical News

[email protected]

Ota nevus is a dermal melanocytosis that is typically characterized by blue, gray, or brown pigmented patches in the periorbital region.¹ The condition has a prevalence of 0.04% in a Philadelphia study of 6915 patients and is most notable in patients with skin of color, affecting up to 0.6% of Asians,² 0.038% of white individuals, and 0.014% of black individuals.^3,4 The appearance of an Ota nevus often imparts a negative psychosocial impact on the patient, prompting requests for treatment and/or removal.⁵Laser treatment of Ota nevi must be carefully implemented, especially in Fitzpatrick skin types IV through VI. Although 532- and 755-nm Q-switched nanosecond lasers have been used to treat Ota nevi,^5,6 typically only moderate improvement is seen; further treatment at higher fluences will only increase the risk for dyspigmentation and scarring.⁶

We report a case of successful treatment of an Ota nevus following 2 treatment sessions with the 532-nm solid-state picosecond laser, which is a novel application in patients with skin of color (Fitzpatrick skin types IV-VI). The Q-switched nanosecond laser has been shown to be moderately effective at treating Ota nevi.⁶ 

Case Report

An 18-year-old woman with Fitzpatrick skin type IV presented for cosmetic removal of an 8×5-cm dark brown-blue patch on the right temple and malar and buccal cheek present since birth that had failed to respond to an unknown laser treatment that was administered outside of the United States (Figure, A). To ascertain the diagnosis, a biopsy was performed, showing histology consistent with Ota nevus. Initially, the 755-nm Q-switched nanosecond laser was recommended for treatment. Over the course of 7 months (1 treatment session per month [Table]), the patient saw improvement but not to the desired extent. The patient then underwent 2 treatments at 4-week intervals with the 1064-nm solid-state picosecond and nanosecond lasers; however, no improvement was seen following these 2 sessions (Table).

The next month the patient received treatment with a novel 532-nm solid-state picosecond laser using the following parameters: fluence, 0.5 J/cm²; spot size, 6 mm; repetition rate, 1 Hz; pulse duration, 750 picoseconds; 339 pulses. The end point was whitening. A remarkable clinical response was demonstrated 6 weeks later (Figure, B). A second treatment with the 532-nm solid-state picosecond laser was then performed at 14 months. On a return visit 2 months after the second treatment, the patient showed dramatic improvement, almost to the degree of complete resolution (Figure, C). 

Comment

Pigmentation disorders are more common in patients with skin of color, and those affected may experience psychological effects secondary to these dermatoses, prompting requests for treatment and/or removal.⁷ Although the 532- and 755-nm Q-switched nanosecond lasers have been used to treat Ota nevi,³ the challenge remains for patients with skin of color, as these lasers work through photothermolysis, which generates heat and may cause thermal damage by targeting melanin. Because more melanin is present in skin of color patients, the threshold for too much heat is lower and these patients are at a higher risk for adverse events such as scarring and hyperpigmentation.^6,8

By delivering energy in shorter pulses, the novel 532-nm solid-state picosecond laser shows greater fragmentation of melanosomes into melanin particles that are eventually phagocytosed.⁸ In our patient, dramatic improvement was noted after only 2 treatments, as evidenced by other picosecond treatments on Ota nevi,^6,8 suggesting that fewer treatments are necessary when using the 532-nm solid-state picosecond laser for Ota nevi.

Although the 532-nm solid-state picosecond laser was cleared by the US Food and Drug Administration for tattoo removal, this laser shows potential use in other pigmentary disorders, particularly in patients with skin of color, as demonstrated in our case. With continued understanding through further studies, this picosecond laser with a shorter pulse duration may prove to be a safer and more effective alternative to the Q-switched nanosecond laser.

Conclusion

As shown in our case, the 532-nm solid-state picosecond laser appears to be a safe and effective modality for treating Ota nevi. This case demonstrates the potential utility of this laser in patients desiring more complete clearing, as it removes pigment more rapidly with lower risk for serious adverse effects. The 9th Cosmetic Surgery Forum will be held November 29-December 2, 2017, in Las Vegas, Nevada. Get more information at www.cosmeticsurgeryforum.com.

Ota nevus is a dermal melanocytosis that is typically characterized by blue, gray, or brown pigmented patches in the periorbital region.¹ The condition has a prevalence of 0.04% in a Philadelphia study of 6915 patients and is most notable in patients with skin of color, affecting up to 0.6% of Asians,² 0.038% of white individuals, and 0.014% of black individuals.^3,4 The appearance of an Ota nevus often imparts a negative psychosocial impact on the patient, prompting requests for treatment and/or removal.⁵Laser treatment of Ota nevi must be carefully implemented, especially in Fitzpatrick skin types IV through VI. Although 532- and 755-nm Q-switched nanosecond lasers have been used to treat Ota nevi,^5,6 typically only moderate improvement is seen; further treatment at higher fluences will only increase the risk for dyspigmentation and scarring.⁶

We report a case of successful treatment of an Ota nevus following 2 treatment sessions with the 532-nm solid-state picosecond laser, which is a novel application in patients with skin of color (Fitzpatrick skin types IV-VI). The Q-switched nanosecond laser has been shown to be moderately effective at treating Ota nevi.⁶ 

Case Report

An 18-year-old woman with Fitzpatrick skin type IV presented for cosmetic removal of an 8×5-cm dark brown-blue patch on the right temple and malar and buccal cheek present since birth that had failed to respond to an unknown laser treatment that was administered outside of the United States (Figure, A). To ascertain the diagnosis, a biopsy was performed, showing histology consistent with Ota nevus. Initially, the 755-nm Q-switched nanosecond laser was recommended for treatment. Over the course of 7 months (1 treatment session per month [Table]), the patient saw improvement but not to the desired extent. The patient then underwent 2 treatments at 4-week intervals with the 1064-nm solid-state picosecond and nanosecond lasers; however, no improvement was seen following these 2 sessions (Table).

The next month the patient received treatment with a novel 532-nm solid-state picosecond laser using the following parameters: fluence, 0.5 J/cm²; spot size, 6 mm; repetition rate, 1 Hz; pulse duration, 750 picoseconds; 339 pulses. The end point was whitening. A remarkable clinical response was demonstrated 6 weeks later (Figure, B). A second treatment with the 532-nm solid-state picosecond laser was then performed at 14 months. On a return visit 2 months after the second treatment, the patient showed dramatic improvement, almost to the degree of complete resolution (Figure, C). 

Comment

Pigmentation disorders are more common in patients with skin of color, and those affected may experience psychological effects secondary to these dermatoses, prompting requests for treatment and/or removal.⁷ Although the 532- and 755-nm Q-switched nanosecond lasers have been used to treat Ota nevi,³ the challenge remains for patients with skin of color, as these lasers work through photothermolysis, which generates heat and may cause thermal damage by targeting melanin. Because more melanin is present in skin of color patients, the threshold for too much heat is lower and these patients are at a higher risk for adverse events such as scarring and hyperpigmentation.^6,8

By delivering energy in shorter pulses, the novel 532-nm solid-state picosecond laser shows greater fragmentation of melanosomes into melanin particles that are eventually phagocytosed.⁸ In our patient, dramatic improvement was noted after only 2 treatments, as evidenced by other picosecond treatments on Ota nevi,^6,8 suggesting that fewer treatments are necessary when using the 532-nm solid-state picosecond laser for Ota nevi.

Although the 532-nm solid-state picosecond laser was cleared by the US Food and Drug Administration for tattoo removal, this laser shows potential use in other pigmentary disorders, particularly in patients with skin of color, as demonstrated in our case. With continued understanding through further studies, this picosecond laser with a shorter pulse duration may prove to be a safer and more effective alternative to the Q-switched nanosecond laser.

Conclusion

As shown in our case, the 532-nm solid-state picosecond laser appears to be a safe and effective modality for treating Ota nevi. This case demonstrates the potential utility of this laser in patients desiring more complete clearing, as it removes pigment more rapidly with lower risk for serious adverse effects. The 9th Cosmetic Surgery Forum will be held November 29-December 2, 2017, in Las Vegas, Nevada. Get more information at www.cosmeticsurgeryforum.com.

Ota nevus is a dermal melanocytosis that is typically characterized by blue, gray, or brown pigmented patches in the periorbital region.¹ The condition has a prevalence of 0.04% in a Philadelphia study of 6915 patients and is most notable in patients with skin of color, affecting up to 0.6% of Asians,² 0.038% of white individuals, and 0.014% of black individuals.^3,4 The appearance of an Ota nevus often imparts a negative psychosocial impact on the patient, prompting requests for treatment and/or removal.⁵Laser treatment of Ota nevi must be carefully implemented, especially in Fitzpatrick skin types IV through VI. Although 532- and 755-nm Q-switched nanosecond lasers have been used to treat Ota nevi,^5,6 typically only moderate improvement is seen; further treatment at higher fluences will only increase the risk for dyspigmentation and scarring.⁶

We report a case of successful treatment of an Ota nevus following 2 treatment sessions with the 532-nm solid-state picosecond laser, which is a novel application in patients with skin of color (Fitzpatrick skin types IV-VI). The Q-switched nanosecond laser has been shown to be moderately effective at treating Ota nevi.⁶ 

Case Report

An 18-year-old woman with Fitzpatrick skin type IV presented for cosmetic removal of an 8×5-cm dark brown-blue patch on the right temple and malar and buccal cheek present since birth that had failed to respond to an unknown laser treatment that was administered outside of the United States (Figure, A). To ascertain the diagnosis, a biopsy was performed, showing histology consistent with Ota nevus. Initially, the 755-nm Q-switched nanosecond laser was recommended for treatment. Over the course of 7 months (1 treatment session per month [Table]), the patient saw improvement but not to the desired extent. The patient then underwent 2 treatments at 4-week intervals with the 1064-nm solid-state picosecond and nanosecond lasers; however, no improvement was seen following these 2 sessions (Table).

The next month the patient received treatment with a novel 532-nm solid-state picosecond laser using the following parameters: fluence, 0.5 J/cm²; spot size, 6 mm; repetition rate, 1 Hz; pulse duration, 750 picoseconds; 339 pulses. The end point was whitening. A remarkable clinical response was demonstrated 6 weeks later (Figure, B). A second treatment with the 532-nm solid-state picosecond laser was then performed at 14 months. On a return visit 2 months after the second treatment, the patient showed dramatic improvement, almost to the degree of complete resolution (Figure, C). 

Comment

Pigmentation disorders are more common in patients with skin of color, and those affected may experience psychological effects secondary to these dermatoses, prompting requests for treatment and/or removal.⁷ Although the 532- and 755-nm Q-switched nanosecond lasers have been used to treat Ota nevi,³ the challenge remains for patients with skin of color, as these lasers work through photothermolysis, which generates heat and may cause thermal damage by targeting melanin. Because more melanin is present in skin of color patients, the threshold for too much heat is lower and these patients are at a higher risk for adverse events such as scarring and hyperpigmentation.^6,8

By delivering energy in shorter pulses, the novel 532-nm solid-state picosecond laser shows greater fragmentation of melanosomes into melanin particles that are eventually phagocytosed.⁸ In our patient, dramatic improvement was noted after only 2 treatments, as evidenced by other picosecond treatments on Ota nevi,^6,8 suggesting that fewer treatments are necessary when using the 532-nm solid-state picosecond laser for Ota nevi.

Although the 532-nm solid-state picosecond laser was cleared by the US Food and Drug Administration for tattoo removal, this laser shows potential use in other pigmentary disorders, particularly in patients with skin of color, as demonstrated in our case. With continued understanding through further studies, this picosecond laser with a shorter pulse duration may prove to be a safer and more effective alternative to the Q-switched nanosecond laser.

Conclusion

As shown in our case, the 532-nm solid-state picosecond laser appears to be a safe and effective modality for treating Ota nevi. This case demonstrates the potential utility of this laser in patients desiring more complete clearing, as it removes pigment more rapidly with lower risk for serious adverse effects. The 9th Cosmetic Surgery Forum will be held November 29-December 2, 2017, in Las Vegas, Nevada. Get more information at www.cosmeticsurgeryforum.com.

The first pregnancy losses with Zika-related birth defects since last summer were reported March 14 by the Centers for Disease Control and Prevention.

Two new cases were reported to the U.S. Zika Pregnancy Registry between Feb. 21 and March 14 – the time period covered by the most recent release of data from the CDC. That brings the total number of Zika virus–related pregnancy losses to seven since the beginning of 2016 in the 50 states and the District of Columbia, along with 54 liveborn infants with Zika-related birth defects. The CDC stopped reporting adverse pregnancy outcomes in Puerto Rico and the other U.S. territories in early October 2016 because Puerto Rico’s Zika Active Pregnancy Surveillance System is not using the same inclusion criteria as its mainland counterpart.

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The first pregnancy losses with Zika-related birth defects since last summer were reported March 14 by the Centers for Disease Control and Prevention.

Two new cases were reported to the U.S. Zika Pregnancy Registry between Feb. 21 and March 14 – the time period covered by the most recent release of data from the CDC. That brings the total number of Zika virus–related pregnancy losses to seven since the beginning of 2016 in the 50 states and the District of Columbia, along with 54 liveborn infants with Zika-related birth defects. The CDC stopped reporting adverse pregnancy outcomes in Puerto Rico and the other U.S. territories in early October 2016 because Puerto Rico’s Zika Active Pregnancy Surveillance System is not using the same inclusion criteria as its mainland counterpart.

[email protected]

The first pregnancy losses with Zika-related birth defects since last summer were reported March 14 by the Centers for Disease Control and Prevention.

Two new cases were reported to the U.S. Zika Pregnancy Registry between Feb. 21 and March 14 – the time period covered by the most recent release of data from the CDC. That brings the total number of Zika virus–related pregnancy losses to seven since the beginning of 2016 in the 50 states and the District of Columbia, along with 54 liveborn infants with Zika-related birth defects. The CDC stopped reporting adverse pregnancy outcomes in Puerto Rico and the other U.S. territories in early October 2016 because Puerto Rico’s Zika Active Pregnancy Surveillance System is not using the same inclusion criteria as its mainland counterpart.

[email protected]

ORLANDO – Accumulating experience is showing the benefits of various models of care for cancer survivors in terms of health care use and costs, while also suggesting that some provide higher-quality care than others, according to a pair of studies reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Initiative for breast cancer survivors

“In 2011, Cancer Care Ontario did a quick environmental scan of our 14 regional cancer centers and found that the transition of breast cancer survivors from oncologists to primary care was very variable, and that centers often didn’t transition patients very frequently,” said Nicole Mittmann, PhD, first author on one of the studies, chief research officer for Cancer Care Ontario, and an investigator at Sunnybrook Research Institute, Toronto.

The advisory organization therefore implemented the Well Follow-Up Care Initiative to facilitate appropriate transition of breast cancer survivors. Each regional center was given a $100,000 incentive to roll out a model of the initiative.

Dr. Mittmann and her coinvestigators used provincial administrative databases to compare health care use and associated costs between 2,324 breast cancer survivors who were transitioned with the initiative and 2,324 propensity-matched control survivors who were not. The survivors were about 5 years out from their breast cancer diagnosis at baseline and had median follow-up of 2 years.

Study results reported at the symposium showed that the mean annual total cost of care per patient paid for by the provincial health ministry was $6,575 for the transitioned group and $10,832 for the nontransitioned group, a difference of $4,257 (39%). The main drivers were reduced costs of long-term care and cancer clinic visits.

Findings were similar for median annual costs, which amounted to $2,261 for the transitioned group and $2,903 for the control group, a difference of $638.

Compared with the nontransitioned group, the transitioned group had significantly fewer annual visits to medical oncologists (0.39 vs. 1.29) and radiation oncologists (0.16 vs. 0.36), while visits to general or family practitioners were statistically indistinguishable (7.35 and 7.91), Dr. Mittmann reported. There was also a trend toward fewer emergency department visits.

The transitioned group had fewer bone scans, CT and MRI scans, and radiographs annually, but differences were not significant.

Reassuringly, Dr. Mittmann said, survivors who were transitioned did not fare worse than their nontransitioned counterparts in overall survival; if anything, they tended to live longer. “We think that because the individual cancer centers enrolled patients that they thought were very well that this is a very well and highly selected and maybe a biased group,” Dr. Mittmann acknowledged. “But we certainly see that they are not doing worse than the control group.”

“About $1.4 million was distributed to the cancer centers” for the initiative, she noted. “That generated a savings for the health system of $1.5 million, if you are looking at median costs, to $9.9 million, if you are looking at mean costs.

“The transition of appropriate breast cancer survivors to the community appears to be safe and effective outside of a clinical trial, at least based on this particular retrospective analysis using databases,” she said. “The overall costs are not increased, and they may actually be decreased based on our data, and certainly these results will inform policy.”

The investigators plan several next steps, such as encouraging senior leadership at Cancer Care Ontario and the Ministry of Health to endorse the findings, according to Dr. Mittmann. In addition, “[we plan to] engage with both oncology and primary care leadership and think about how we can potentially roll out a program like this, and develop tools, whether those are letters or information packages, and education, to … appropriately transition individuals.”

Considerations in interpreting the study’s findings include the quality of the matching of survivors, according to invited discussant Monika K. Krzyzanowska, MD, a medical oncologist at Princess Margaret Cancer Centre, an associate professor at the University of Toronto, and a clinical lead of Quality Care and Access, Systemic Treatment Program, at Cancer Care Ontario. “The quality of that match depends on what’s in the model, so there could be potential for residual confounding, and administrative data may not have all of the elements that you would need to get a perfect match.”

Comparison of survivorship care models

Two-thirds of the large and growing population of cancer survivors are at least 5 years out from diagnosis, stimulating considerable discussion in the oncology community about how to best address their needs, according to Sarah Raskin, PhD, senior author on the second study and a research scientist at the Institute for Patient-Centered Initiatives and Health Equity at George Washington University Cancer Center, Washington.

“Yet, for a lack of cancer survivorship–specific guidelines from research or practice, cancer centers are increasingly developing survivorship care in a variety of ways, many of which are ad hoc or unproven as yet,” she said.

Dr. Raskin and her colleagues compared three emerging models of survivorship care: a specialized consultative model and a specialized longitudinal model – whereby patients have a single or multiple formalized survivorship visits, respectively, with care typically led by an oncology nurse-practitioner – and an oncology-embedded model – whereby survivorship is addressed as a part of ongoing oncology follow-up care, typically by the oncologist.

The investigators worked with survivors to develop the Patient-Prioritized Measure of High-Quality Survivorship Care, a 46-question scale assessing nine components of survivorship care that capture the health care priorities and needs that matter most to patients. Each component is rated on a scale from 0 (not at all met) to 1 (somewhat met) to 2 (definitely met).

Analyses were based on responses of 827 survivors of breast, colorectal, and prostate cancer who received care at 28 U.S. institutions using one of the above models and who were surveyed by telephone about the care received 1 week after their initial survivorship visit.

Results showed that survivors cared for under the three models differed significantly with respect to scores for seven of the nine components of quality of care, Dr. Raskin reported. The exceptions were practical life support, where the mean score was about 0.6-0.8 across the board, and having a medical home, where the mean score was about 1.8-1.9 across the board.

The specialized consult model of care had the highest scores for mental health and social support, information and resources, and supportive and prepared clinicians. The specialized longitudinal model of care had the highest scores for empowered and engaged patients, open patient-clinician communication, care coordination and transitions, and access to full spectrum of care. The oncology-embedded model had the lowest scores. Analysis of the tool’s 46 individual questions showed that patients cared for at institutions using the oncology-embedded model were significantly less likely than were counterparts cared for at institutions using the specialized models to report that the institution performed various activities such as offering a treatment summary, inquiring about the patient’s biggest worries or problems, and explaining the reasons why tests were needed (P less than .05 for each).

For some metrics, the overall proportion reporting that an activity was performed was low, regardless of the model being used. For example, only 48% of all patients reported being helped to set goals or make short-term plans to manage follow-up care and improve health, merely 24% reported being provided emotional and social support to deal with changes in relationships, and just 19% reported being referred to special providers for other medical problems.

“Overall, all three models are performing highly in terms of providing survivors with a medical home and communicating with patients. However, all three are performing quite low in terms of providing mental health and social support, as well as practical life support,” said Dr. Raskin.

“By model, we see that the embedded ongoing care model is significantly underperforming compared with both specialized models on seven of nine components, and we have some hypotheses from our early work with [Commission on Cancer]–accredited centers to explain this,” she added. “Embedded survivorship models have a lot of variability – many are high performers but others are low performers as compared with specialized programs. Embedded survivorship care models are typically led by the treating oncologist, who historically has focused on treating sick patients and less so on providing social supports for follow-up of well patients or ‘well-er’ patients. At the same time, specialized models focus predominantly on survivorship care and providing services and referrals for survivors, which may explain their high scores.

“We know that the higher quality of care measures presented here do not necessarily translate to better patient outcomes, and that’s actually going to be the next phase of our analysis,” she concluded.

The study sample may have had some selection bias, and it is unclear how well validated the tool was, according to Dr. Krzyzanowska, the discussant. Another issue was its assessment of quality of care at only a single time point.

Nonetheless, the findings show “that measuring quality of survivorship care from a patient perspective is feasible and valuable. We have already heard about [need for] survivorship plans in survivorship care, so certainly the work that was just presented is extremely important to help to fill some of these gaps,” she said.

“I’m not sure that we yet know what the optimal model of survivorship care is without the information of the other outcomes. Furthermore, there’s different survivor populations and different ways that health care is organized, so perhaps there isn’t really one optimal model, but the model has to fit with the context,” Dr. Krzyzanowska concluded. “That being said … the tool that they have created can be a great tool for existing survivorship care programs to assess and improve the quality of their care.”

Dr. Mittmann and Dr. Raskin had no disclosures to report.

ORLANDO – Accumulating experience is showing the benefits of various models of care for cancer survivors in terms of health care use and costs, while also suggesting that some provide higher-quality care than others, according to a pair of studies reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Initiative for breast cancer survivors

“In 2011, Cancer Care Ontario did a quick environmental scan of our 14 regional cancer centers and found that the transition of breast cancer survivors from oncologists to primary care was very variable, and that centers often didn’t transition patients very frequently,” said Nicole Mittmann, PhD, first author on one of the studies, chief research officer for Cancer Care Ontario, and an investigator at Sunnybrook Research Institute, Toronto.

The advisory organization therefore implemented the Well Follow-Up Care Initiative to facilitate appropriate transition of breast cancer survivors. Each regional center was given a $100,000 incentive to roll out a model of the initiative.

Dr. Mittmann and her coinvestigators used provincial administrative databases to compare health care use and associated costs between 2,324 breast cancer survivors who were transitioned with the initiative and 2,324 propensity-matched control survivors who were not. The survivors were about 5 years out from their breast cancer diagnosis at baseline and had median follow-up of 2 years.

Study results reported at the symposium showed that the mean annual total cost of care per patient paid for by the provincial health ministry was $6,575 for the transitioned group and $10,832 for the nontransitioned group, a difference of $4,257 (39%). The main drivers were reduced costs of long-term care and cancer clinic visits.

Findings were similar for median annual costs, which amounted to $2,261 for the transitioned group and $2,903 for the control group, a difference of $638.

Compared with the nontransitioned group, the transitioned group had significantly fewer annual visits to medical oncologists (0.39 vs. 1.29) and radiation oncologists (0.16 vs. 0.36), while visits to general or family practitioners were statistically indistinguishable (7.35 and 7.91), Dr. Mittmann reported. There was also a trend toward fewer emergency department visits.

The transitioned group had fewer bone scans, CT and MRI scans, and radiographs annually, but differences were not significant.

Reassuringly, Dr. Mittmann said, survivors who were transitioned did not fare worse than their nontransitioned counterparts in overall survival; if anything, they tended to live longer. “We think that because the individual cancer centers enrolled patients that they thought were very well that this is a very well and highly selected and maybe a biased group,” Dr. Mittmann acknowledged. “But we certainly see that they are not doing worse than the control group.”

“About $1.4 million was distributed to the cancer centers” for the initiative, she noted. “That generated a savings for the health system of $1.5 million, if you are looking at median costs, to $9.9 million, if you are looking at mean costs.

“The transition of appropriate breast cancer survivors to the community appears to be safe and effective outside of a clinical trial, at least based on this particular retrospective analysis using databases,” she said. “The overall costs are not increased, and they may actually be decreased based on our data, and certainly these results will inform policy.”

The investigators plan several next steps, such as encouraging senior leadership at Cancer Care Ontario and the Ministry of Health to endorse the findings, according to Dr. Mittmann. In addition, “[we plan to] engage with both oncology and primary care leadership and think about how we can potentially roll out a program like this, and develop tools, whether those are letters or information packages, and education, to … appropriately transition individuals.”

Considerations in interpreting the study’s findings include the quality of the matching of survivors, according to invited discussant Monika K. Krzyzanowska, MD, a medical oncologist at Princess Margaret Cancer Centre, an associate professor at the University of Toronto, and a clinical lead of Quality Care and Access, Systemic Treatment Program, at Cancer Care Ontario. “The quality of that match depends on what’s in the model, so there could be potential for residual confounding, and administrative data may not have all of the elements that you would need to get a perfect match.”

Comparison of survivorship care models

Two-thirds of the large and growing population of cancer survivors are at least 5 years out from diagnosis, stimulating considerable discussion in the oncology community about how to best address their needs, according to Sarah Raskin, PhD, senior author on the second study and a research scientist at the Institute for Patient-Centered Initiatives and Health Equity at George Washington University Cancer Center, Washington.

“Yet, for a lack of cancer survivorship–specific guidelines from research or practice, cancer centers are increasingly developing survivorship care in a variety of ways, many of which are ad hoc or unproven as yet,” she said.

Dr. Raskin and her colleagues compared three emerging models of survivorship care: a specialized consultative model and a specialized longitudinal model – whereby patients have a single or multiple formalized survivorship visits, respectively, with care typically led by an oncology nurse-practitioner – and an oncology-embedded model – whereby survivorship is addressed as a part of ongoing oncology follow-up care, typically by the oncologist.

The investigators worked with survivors to develop the Patient-Prioritized Measure of High-Quality Survivorship Care, a 46-question scale assessing nine components of survivorship care that capture the health care priorities and needs that matter most to patients. Each component is rated on a scale from 0 (not at all met) to 1 (somewhat met) to 2 (definitely met).

Analyses were based on responses of 827 survivors of breast, colorectal, and prostate cancer who received care at 28 U.S. institutions using one of the above models and who were surveyed by telephone about the care received 1 week after their initial survivorship visit.

Results showed that survivors cared for under the three models differed significantly with respect to scores for seven of the nine components of quality of care, Dr. Raskin reported. The exceptions were practical life support, where the mean score was about 0.6-0.8 across the board, and having a medical home, where the mean score was about 1.8-1.9 across the board.

The specialized consult model of care had the highest scores for mental health and social support, information and resources, and supportive and prepared clinicians. The specialized longitudinal model of care had the highest scores for empowered and engaged patients, open patient-clinician communication, care coordination and transitions, and access to full spectrum of care. The oncology-embedded model had the lowest scores. Analysis of the tool’s 46 individual questions showed that patients cared for at institutions using the oncology-embedded model were significantly less likely than were counterparts cared for at institutions using the specialized models to report that the institution performed various activities such as offering a treatment summary, inquiring about the patient’s biggest worries or problems, and explaining the reasons why tests were needed (P less than .05 for each).

For some metrics, the overall proportion reporting that an activity was performed was low, regardless of the model being used. For example, only 48% of all patients reported being helped to set goals or make short-term plans to manage follow-up care and improve health, merely 24% reported being provided emotional and social support to deal with changes in relationships, and just 19% reported being referred to special providers for other medical problems.

“Overall, all three models are performing highly in terms of providing survivors with a medical home and communicating with patients. However, all three are performing quite low in terms of providing mental health and social support, as well as practical life support,” said Dr. Raskin.

“By model, we see that the embedded ongoing care model is significantly underperforming compared with both specialized models on seven of nine components, and we have some hypotheses from our early work with [Commission on Cancer]–accredited centers to explain this,” she added. “Embedded survivorship models have a lot of variability – many are high performers but others are low performers as compared with specialized programs. Embedded survivorship care models are typically led by the treating oncologist, who historically has focused on treating sick patients and less so on providing social supports for follow-up of well patients or ‘well-er’ patients. At the same time, specialized models focus predominantly on survivorship care and providing services and referrals for survivors, which may explain their high scores.

“We know that the higher quality of care measures presented here do not necessarily translate to better patient outcomes, and that’s actually going to be the next phase of our analysis,” she concluded.

The study sample may have had some selection bias, and it is unclear how well validated the tool was, according to Dr. Krzyzanowska, the discussant. Another issue was its assessment of quality of care at only a single time point.

Nonetheless, the findings show “that measuring quality of survivorship care from a patient perspective is feasible and valuable. We have already heard about [need for] survivorship plans in survivorship care, so certainly the work that was just presented is extremely important to help to fill some of these gaps,” she said.

“I’m not sure that we yet know what the optimal model of survivorship care is without the information of the other outcomes. Furthermore, there’s different survivor populations and different ways that health care is organized, so perhaps there isn’t really one optimal model, but the model has to fit with the context,” Dr. Krzyzanowska concluded. “That being said … the tool that they have created can be a great tool for existing survivorship care programs to assess and improve the quality of their care.”

Dr. Mittmann and Dr. Raskin had no disclosures to report.

ORLANDO – Accumulating experience is showing the benefits of various models of care for cancer survivors in terms of health care use and costs, while also suggesting that some provide higher-quality care than others, according to a pair of studies reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Initiative for breast cancer survivors

“In 2011, Cancer Care Ontario did a quick environmental scan of our 14 regional cancer centers and found that the transition of breast cancer survivors from oncologists to primary care was very variable, and that centers often didn’t transition patients very frequently,” said Nicole Mittmann, PhD, first author on one of the studies, chief research officer for Cancer Care Ontario, and an investigator at Sunnybrook Research Institute, Toronto.

The advisory organization therefore implemented the Well Follow-Up Care Initiative to facilitate appropriate transition of breast cancer survivors. Each regional center was given a $100,000 incentive to roll out a model of the initiative.

Dr. Mittmann and her coinvestigators used provincial administrative databases to compare health care use and associated costs between 2,324 breast cancer survivors who were transitioned with the initiative and 2,324 propensity-matched control survivors who were not. The survivors were about 5 years out from their breast cancer diagnosis at baseline and had median follow-up of 2 years.

Study results reported at the symposium showed that the mean annual total cost of care per patient paid for by the provincial health ministry was $6,575 for the transitioned group and $10,832 for the nontransitioned group, a difference of $4,257 (39%). The main drivers were reduced costs of long-term care and cancer clinic visits.

Findings were similar for median annual costs, which amounted to $2,261 for the transitioned group and $2,903 for the control group, a difference of $638.

Compared with the nontransitioned group, the transitioned group had significantly fewer annual visits to medical oncologists (0.39 vs. 1.29) and radiation oncologists (0.16 vs. 0.36), while visits to general or family practitioners were statistically indistinguishable (7.35 and 7.91), Dr. Mittmann reported. There was also a trend toward fewer emergency department visits.

The transitioned group had fewer bone scans, CT and MRI scans, and radiographs annually, but differences were not significant.

Reassuringly, Dr. Mittmann said, survivors who were transitioned did not fare worse than their nontransitioned counterparts in overall survival; if anything, they tended to live longer. “We think that because the individual cancer centers enrolled patients that they thought were very well that this is a very well and highly selected and maybe a biased group,” Dr. Mittmann acknowledged. “But we certainly see that they are not doing worse than the control group.”

“About $1.4 million was distributed to the cancer centers” for the initiative, she noted. “That generated a savings for the health system of $1.5 million, if you are looking at median costs, to $9.9 million, if you are looking at mean costs.

“The transition of appropriate breast cancer survivors to the community appears to be safe and effective outside of a clinical trial, at least based on this particular retrospective analysis using databases,” she said. “The overall costs are not increased, and they may actually be decreased based on our data, and certainly these results will inform policy.”

The investigators plan several next steps, such as encouraging senior leadership at Cancer Care Ontario and the Ministry of Health to endorse the findings, according to Dr. Mittmann. In addition, “[we plan to] engage with both oncology and primary care leadership and think about how we can potentially roll out a program like this, and develop tools, whether those are letters or information packages, and education, to … appropriately transition individuals.”

Considerations in interpreting the study’s findings include the quality of the matching of survivors, according to invited discussant Monika K. Krzyzanowska, MD, a medical oncologist at Princess Margaret Cancer Centre, an associate professor at the University of Toronto, and a clinical lead of Quality Care and Access, Systemic Treatment Program, at Cancer Care Ontario. “The quality of that match depends on what’s in the model, so there could be potential for residual confounding, and administrative data may not have all of the elements that you would need to get a perfect match.”

Comparison of survivorship care models

Two-thirds of the large and growing population of cancer survivors are at least 5 years out from diagnosis, stimulating considerable discussion in the oncology community about how to best address their needs, according to Sarah Raskin, PhD, senior author on the second study and a research scientist at the Institute for Patient-Centered Initiatives and Health Equity at George Washington University Cancer Center, Washington.

“Yet, for a lack of cancer survivorship–specific guidelines from research or practice, cancer centers are increasingly developing survivorship care in a variety of ways, many of which are ad hoc or unproven as yet,” she said.

Dr. Raskin and her colleagues compared three emerging models of survivorship care: a specialized consultative model and a specialized longitudinal model – whereby patients have a single or multiple formalized survivorship visits, respectively, with care typically led by an oncology nurse-practitioner – and an oncology-embedded model – whereby survivorship is addressed as a part of ongoing oncology follow-up care, typically by the oncologist.

The investigators worked with survivors to develop the Patient-Prioritized Measure of High-Quality Survivorship Care, a 46-question scale assessing nine components of survivorship care that capture the health care priorities and needs that matter most to patients. Each component is rated on a scale from 0 (not at all met) to 1 (somewhat met) to 2 (definitely met).

Analyses were based on responses of 827 survivors of breast, colorectal, and prostate cancer who received care at 28 U.S. institutions using one of the above models and who were surveyed by telephone about the care received 1 week after their initial survivorship visit.

Results showed that survivors cared for under the three models differed significantly with respect to scores for seven of the nine components of quality of care, Dr. Raskin reported. The exceptions were practical life support, where the mean score was about 0.6-0.8 across the board, and having a medical home, where the mean score was about 1.8-1.9 across the board.

The specialized consult model of care had the highest scores for mental health and social support, information and resources, and supportive and prepared clinicians. The specialized longitudinal model of care had the highest scores for empowered and engaged patients, open patient-clinician communication, care coordination and transitions, and access to full spectrum of care. The oncology-embedded model had the lowest scores. Analysis of the tool’s 46 individual questions showed that patients cared for at institutions using the oncology-embedded model were significantly less likely than were counterparts cared for at institutions using the specialized models to report that the institution performed various activities such as offering a treatment summary, inquiring about the patient’s biggest worries or problems, and explaining the reasons why tests were needed (P less than .05 for each).

For some metrics, the overall proportion reporting that an activity was performed was low, regardless of the model being used. For example, only 48% of all patients reported being helped to set goals or make short-term plans to manage follow-up care and improve health, merely 24% reported being provided emotional and social support to deal with changes in relationships, and just 19% reported being referred to special providers for other medical problems.

“Overall, all three models are performing highly in terms of providing survivors with a medical home and communicating with patients. However, all three are performing quite low in terms of providing mental health and social support, as well as practical life support,” said Dr. Raskin.

“By model, we see that the embedded ongoing care model is significantly underperforming compared with both specialized models on seven of nine components, and we have some hypotheses from our early work with [Commission on Cancer]–accredited centers to explain this,” she added. “Embedded survivorship models have a lot of variability – many are high performers but others are low performers as compared with specialized programs. Embedded survivorship care models are typically led by the treating oncologist, who historically has focused on treating sick patients and less so on providing social supports for follow-up of well patients or ‘well-er’ patients. At the same time, specialized models focus predominantly on survivorship care and providing services and referrals for survivors, which may explain their high scores.

“We know that the higher quality of care measures presented here do not necessarily translate to better patient outcomes, and that’s actually going to be the next phase of our analysis,” she concluded.

The study sample may have had some selection bias, and it is unclear how well validated the tool was, according to Dr. Krzyzanowska, the discussant. Another issue was its assessment of quality of care at only a single time point.

Nonetheless, the findings show “that measuring quality of survivorship care from a patient perspective is feasible and valuable. We have already heard about [need for] survivorship plans in survivorship care, so certainly the work that was just presented is extremely important to help to fill some of these gaps,” she said.

“I’m not sure that we yet know what the optimal model of survivorship care is without the information of the other outcomes. Furthermore, there’s different survivor populations and different ways that health care is organized, so perhaps there isn’t really one optimal model, but the model has to fit with the context,” Dr. Krzyzanowska concluded. “That being said … the tool that they have created can be a great tool for existing survivorship care programs to assess and improve the quality of their care.”

Dr. Mittmann and Dr. Raskin had no disclosures to report.

Surgeons need to do more to identify patients who are taking opioids preoperatively, because this is a population that appears to be at a higher risk of worse surgical outcomes, according to a large retrospective investigation.

“Opioid users represent a potentially high-risk surgical population and may require tailored perioperative care [and] the prevalence and clinical impact of this problem in the general surgery population remain unclear,” wrote the authors of a study, led by David C. Cron, a medical student of the University of Michigan, Ann Arbor. “Given the impact of pain control and gastrointestinal function on hospital stay, it is intuitive that opioid users may have increased hospital length of stay (LOS) and may incur more costs [and] also be at higher risk for surgical complications.”

The study was published in the Annals of Surgery (2017;465[4]696-701).

Mr. Cron and his coauthors made a study cohort retrospectively from abdominopelvic surgery patients from the Michigan Surgical Quality Collaborative (MSQC) database who had surgery between 2008 and 2014. All patients were treated at the University of Michigan, and were admitted within 2 days of undergoing their operation. Any patient with data indicating use of buprenorphine prior to surgery, or those were who opioid naive before admission but received opioids after being admitted, were excluded.

Investigators found a total of 3,107 patients in the MSQC database that underwent abdominopelvic surgery at the University of Michigan during the designated time frame; from that group, 2,413 were ultimately found to match the inclusion criteria for the study. The primary outcomes were 90-day total hospital costs, along with patient LOS, and 30-day rates of complications and readmissions. Data underwent covariate risk adjustment to account for age, race, gender, body mass index, insurance class, and other factors.

“Major complications are recorded by the MSQC and include: surgical site infection, deep venous thrombosis, acute renal failure, postoperative bleeding requiring transfusion, stroke, unplanned intubation, fascial dehiscence, prolonged mechanical ventilation longer than 48 hours, myocardial infarction, pneumonia, pulmonary embolism, sepsis, vascular graft loss, and renal insufficiency,” the authors noted.

Of the 2,413 subjects overall, 502 (20.8%) were found to use opioids before surgery. Differences between opioid users and nonusers were not significant in terms of age (P = .10), gender (P = .76), and race (P = .78). After adjustment, data indicated that preoperative opioid users had 9.2% higher hospital costs than nonusers (95% confidence interval, 2.8%-15.6%, P = .005) and 12.4% longer hospital stay (95% CI, 2.3%-23.5%; P = .015). Complications and readmission rates were quantified by odds ratios, which were also found to be significantly higher in subjects who were preoperative opioid users: OR = 1.36 (95% CI, 1.04-1.78; P = .023) and OR = 1.57 (95% CI, 1.08-2.29; P = .018), respectively.

The study had some limitations, including being conducted at a single center and potentially not generalizable to other types of health care facilities and population types. Additionally, information on opioid dosage and duration of use was lacking, making it that “possible that some opioid users in our study were using opioids over a shorter time period for pain related to their surgical disease,” according to the investigators.

“These results argue the potential cost-effectiveness of intervention in this unique patient population,” Mr. Cron and his colleagues concluded. “Opioid use is a potentially modifiable risk factor, and major surgery can provide powerful leverage to improve health behavior [and] our institution has implemented a preoperative program to optimize high-risk patients for surgery.”

Mr. Cron received funding from the 2015 AOA Carolyn L. Kuckein Student Research Fellowship and the Blue Cross Blue Shield of Michigan Foundation Student Research Award for this study. He and his coauthors reported no relevant financial disclosures.

[email protected]

Surgeons need to do more to identify patients who are taking opioids preoperatively, because this is a population that appears to be at a higher risk of worse surgical outcomes, according to a large retrospective investigation.

“Opioid users represent a potentially high-risk surgical population and may require tailored perioperative care [and] the prevalence and clinical impact of this problem in the general surgery population remain unclear,” wrote the authors of a study, led by David C. Cron, a medical student of the University of Michigan, Ann Arbor. “Given the impact of pain control and gastrointestinal function on hospital stay, it is intuitive that opioid users may have increased hospital length of stay (LOS) and may incur more costs [and] also be at higher risk for surgical complications.”

The study was published in the Annals of Surgery (2017;465[4]696-701).

Mr. Cron and his coauthors made a study cohort retrospectively from abdominopelvic surgery patients from the Michigan Surgical Quality Collaborative (MSQC) database who had surgery between 2008 and 2014. All patients were treated at the University of Michigan, and were admitted within 2 days of undergoing their operation. Any patient with data indicating use of buprenorphine prior to surgery, or those were who opioid naive before admission but received opioids after being admitted, were excluded.

Investigators found a total of 3,107 patients in the MSQC database that underwent abdominopelvic surgery at the University of Michigan during the designated time frame; from that group, 2,413 were ultimately found to match the inclusion criteria for the study. The primary outcomes were 90-day total hospital costs, along with patient LOS, and 30-day rates of complications and readmissions. Data underwent covariate risk adjustment to account for age, race, gender, body mass index, insurance class, and other factors.

“Major complications are recorded by the MSQC and include: surgical site infection, deep venous thrombosis, acute renal failure, postoperative bleeding requiring transfusion, stroke, unplanned intubation, fascial dehiscence, prolonged mechanical ventilation longer than 48 hours, myocardial infarction, pneumonia, pulmonary embolism, sepsis, vascular graft loss, and renal insufficiency,” the authors noted.

Of the 2,413 subjects overall, 502 (20.8%) were found to use opioids before surgery. Differences between opioid users and nonusers were not significant in terms of age (P = .10), gender (P = .76), and race (P = .78). After adjustment, data indicated that preoperative opioid users had 9.2% higher hospital costs than nonusers (95% confidence interval, 2.8%-15.6%, P = .005) and 12.4% longer hospital stay (95% CI, 2.3%-23.5%; P = .015). Complications and readmission rates were quantified by odds ratios, which were also found to be significantly higher in subjects who were preoperative opioid users: OR = 1.36 (95% CI, 1.04-1.78; P = .023) and OR = 1.57 (95% CI, 1.08-2.29; P = .018), respectively.

The study had some limitations, including being conducted at a single center and potentially not generalizable to other types of health care facilities and population types. Additionally, information on opioid dosage and duration of use was lacking, making it that “possible that some opioid users in our study were using opioids over a shorter time period for pain related to their surgical disease,” according to the investigators.

“These results argue the potential cost-effectiveness of intervention in this unique patient population,” Mr. Cron and his colleagues concluded. “Opioid use is a potentially modifiable risk factor, and major surgery can provide powerful leverage to improve health behavior [and] our institution has implemented a preoperative program to optimize high-risk patients for surgery.”

Mr. Cron received funding from the 2015 AOA Carolyn L. Kuckein Student Research Fellowship and the Blue Cross Blue Shield of Michigan Foundation Student Research Award for this study. He and his coauthors reported no relevant financial disclosures.

[email protected]

Surgeons need to do more to identify patients who are taking opioids preoperatively, because this is a population that appears to be at a higher risk of worse surgical outcomes, according to a large retrospective investigation.

“Opioid users represent a potentially high-risk surgical population and may require tailored perioperative care [and] the prevalence and clinical impact of this problem in the general surgery population remain unclear,” wrote the authors of a study, led by David C. Cron, a medical student of the University of Michigan, Ann Arbor. “Given the impact of pain control and gastrointestinal function on hospital stay, it is intuitive that opioid users may have increased hospital length of stay (LOS) and may incur more costs [and] also be at higher risk for surgical complications.”

The study was published in the Annals of Surgery (2017;465[4]696-701).

Mr. Cron and his coauthors made a study cohort retrospectively from abdominopelvic surgery patients from the Michigan Surgical Quality Collaborative (MSQC) database who had surgery between 2008 and 2014. All patients were treated at the University of Michigan, and were admitted within 2 days of undergoing their operation. Any patient with data indicating use of buprenorphine prior to surgery, or those were who opioid naive before admission but received opioids after being admitted, were excluded.

Investigators found a total of 3,107 patients in the MSQC database that underwent abdominopelvic surgery at the University of Michigan during the designated time frame; from that group, 2,413 were ultimately found to match the inclusion criteria for the study. The primary outcomes were 90-day total hospital costs, along with patient LOS, and 30-day rates of complications and readmissions. Data underwent covariate risk adjustment to account for age, race, gender, body mass index, insurance class, and other factors.

“Major complications are recorded by the MSQC and include: surgical site infection, deep venous thrombosis, acute renal failure, postoperative bleeding requiring transfusion, stroke, unplanned intubation, fascial dehiscence, prolonged mechanical ventilation longer than 48 hours, myocardial infarction, pneumonia, pulmonary embolism, sepsis, vascular graft loss, and renal insufficiency,” the authors noted.

Of the 2,413 subjects overall, 502 (20.8%) were found to use opioids before surgery. Differences between opioid users and nonusers were not significant in terms of age (P = .10), gender (P = .76), and race (P = .78). After adjustment, data indicated that preoperative opioid users had 9.2% higher hospital costs than nonusers (95% confidence interval, 2.8%-15.6%, P = .005) and 12.4% longer hospital stay (95% CI, 2.3%-23.5%; P = .015). Complications and readmission rates were quantified by odds ratios, which were also found to be significantly higher in subjects who were preoperative opioid users: OR = 1.36 (95% CI, 1.04-1.78; P = .023) and OR = 1.57 (95% CI, 1.08-2.29; P = .018), respectively.

The study had some limitations, including being conducted at a single center and potentially not generalizable to other types of health care facilities and population types. Additionally, information on opioid dosage and duration of use was lacking, making it that “possible that some opioid users in our study were using opioids over a shorter time period for pain related to their surgical disease,” according to the investigators.

“These results argue the potential cost-effectiveness of intervention in this unique patient population,” Mr. Cron and his colleagues concluded. “Opioid use is a potentially modifiable risk factor, and major surgery can provide powerful leverage to improve health behavior [and] our institution has implemented a preoperative program to optimize high-risk patients for surgery.”

Mr. Cron received funding from the 2015 AOA Carolyn L. Kuckein Student Research Fellowship and the Blue Cross Blue Shield of Michigan Foundation Student Research Award for this study. He and his coauthors reported no relevant financial disclosures.

[email protected]

ATLANTA – For low-income and minority children with asthma, parents’ perception of a child’s asthma control may be an important predictor of future acute visits, independent of guideline-based criteria for asthma control, judging from the results from a prospective cohort study.

The National Asthma Education and Prevention Program (NAEPP)–based assessment of asthma control incorporates symptoms, nighttime awakenings, and activity interference; short-acting beta 2-agonist use, lung function, and history of exacerbations, “but it does not take into account parental perceptions of asthma control,” lead study author Suzanne Rossi, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “We also know that parental report of symptom frequency and their perception of their child’s asthma control are frequently discordant.”

marekuliasz/Thinkstock

[email protected]

ATLANTA – For low-income and minority children with asthma, parents’ perception of a child’s asthma control may be an important predictor of future acute visits, independent of guideline-based criteria for asthma control, judging from the results from a prospective cohort study.

The National Asthma Education and Prevention Program (NAEPP)–based assessment of asthma control incorporates symptoms, nighttime awakenings, and activity interference; short-acting beta 2-agonist use, lung function, and history of exacerbations, “but it does not take into account parental perceptions of asthma control,” lead study author Suzanne Rossi, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “We also know that parental report of symptom frequency and their perception of their child’s asthma control are frequently discordant.”

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ATLANTA – For low-income and minority children with asthma, parents’ perception of a child’s asthma control may be an important predictor of future acute visits, independent of guideline-based criteria for asthma control, judging from the results from a prospective cohort study.

The National Asthma Education and Prevention Program (NAEPP)–based assessment of asthma control incorporates symptoms, nighttime awakenings, and activity interference; short-acting beta 2-agonist use, lung function, and history of exacerbations, “but it does not take into account parental perceptions of asthma control,” lead study author Suzanne Rossi, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “We also know that parental report of symptom frequency and their perception of their child’s asthma control are frequently discordant.”

marekuliasz/Thinkstock

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In the July 2010 issue of GI & Hepatology News, Dr. Howard Levy reviewed a number of strategies for recognizing of hereditary colon cancer, specifically Lynch syndrome. At that time, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group had recommended universal molecular tumor testing.

The EGAPP recommendation was the first of several ensuing endorsements of universal tumor testing using immunohistochemistry (IHC) or microsatellite instability (MSI) analysis. For example, the AGA Guideline on Diagnosis and Management of Lynch Syndrome (Gastroenterology. 2015;149[3]:777-82) issued a strong recommendation for tumor testing. We have learned about reflexive BRAF or promoter hypermethylation testing and, in some cases, tumor sequencing for double somatic mutations to identify sporadic MSI-high cases. While tumor testing is widely endorsed and is cost effective, implementation and quality control still remain challenges in clinical practice.

In addition to widespread endorsement of tumor testing, there have been a number of important developments in our understanding of Lynch syndrome. A recent publication estimated the prevalence of mismatch-repair gene mutations associated with Lynch syndrome at 1 in 279. Cancer risks in Lynch syndrome are significantly elevated over the general population, and it has become clear that there are distinct risk estimates depending on the gene that is mutated. New risk prediction models, such as PREMM1,2,6, have improved test characteristics over Amsterdam and Bethesda criteria for identification of mutation carriers. The Colorectal Adenoma/Carcinoma Prevention Programme (CAPP) trials have shown that aspirin is chemopreventive in Lynch syndrome. Survival in Lynch syndrome patients who develop colorectal cancer is over 90% based on results from a prospective database. Immune checkpoint inhibitor therapy has been shown to be effective in treatment of metastatic MSI-high colorectal cancer including from Lynch syndrome patients. Immunotherapy has also shown to be effective in patients with biallelic mismatch repair deficiency (BMMRD), a childhood cancer syndrome characterized by brain and gastrointestinal tumors, among others.

Sonia S. Kupfer, MD, is assistant professor of gastroenterology, director of the Gastrointestinal Cancer Risk and Prevention Clinic at the University of Chicago, and an Associate Editor of GI & Hepatology News.

In the July 2010 issue of GI & Hepatology News, Dr. Howard Levy reviewed a number of strategies for recognizing of hereditary colon cancer, specifically Lynch syndrome. At that time, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group had recommended universal molecular tumor testing.

The EGAPP recommendation was the first of several ensuing endorsements of universal tumor testing using immunohistochemistry (IHC) or microsatellite instability (MSI) analysis. For example, the AGA Guideline on Diagnosis and Management of Lynch Syndrome (Gastroenterology. 2015;149[3]:777-82) issued a strong recommendation for tumor testing. We have learned about reflexive BRAF or promoter hypermethylation testing and, in some cases, tumor sequencing for double somatic mutations to identify sporadic MSI-high cases. While tumor testing is widely endorsed and is cost effective, implementation and quality control still remain challenges in clinical practice.

In addition to widespread endorsement of tumor testing, there have been a number of important developments in our understanding of Lynch syndrome. A recent publication estimated the prevalence of mismatch-repair gene mutations associated with Lynch syndrome at 1 in 279. Cancer risks in Lynch syndrome are significantly elevated over the general population, and it has become clear that there are distinct risk estimates depending on the gene that is mutated. New risk prediction models, such as PREMM1,2,6, have improved test characteristics over Amsterdam and Bethesda criteria for identification of mutation carriers. The Colorectal Adenoma/Carcinoma Prevention Programme (CAPP) trials have shown that aspirin is chemopreventive in Lynch syndrome. Survival in Lynch syndrome patients who develop colorectal cancer is over 90% based on results from a prospective database. Immune checkpoint inhibitor therapy has been shown to be effective in treatment of metastatic MSI-high colorectal cancer including from Lynch syndrome patients. Immunotherapy has also shown to be effective in patients with biallelic mismatch repair deficiency (BMMRD), a childhood cancer syndrome characterized by brain and gastrointestinal tumors, among others.

Sonia S. Kupfer, MD, is assistant professor of gastroenterology, director of the Gastrointestinal Cancer Risk and Prevention Clinic at the University of Chicago, and an Associate Editor of GI & Hepatology News.

In the July 2010 issue of GI & Hepatology News, Dr. Howard Levy reviewed a number of strategies for recognizing of hereditary colon cancer, specifically Lynch syndrome. At that time, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group had recommended universal molecular tumor testing.

The EGAPP recommendation was the first of several ensuing endorsements of universal tumor testing using immunohistochemistry (IHC) or microsatellite instability (MSI) analysis. For example, the AGA Guideline on Diagnosis and Management of Lynch Syndrome (Gastroenterology. 2015;149[3]:777-82) issued a strong recommendation for tumor testing. We have learned about reflexive BRAF or promoter hypermethylation testing and, in some cases, tumor sequencing for double somatic mutations to identify sporadic MSI-high cases. While tumor testing is widely endorsed and is cost effective, implementation and quality control still remain challenges in clinical practice.

In addition to widespread endorsement of tumor testing, there have been a number of important developments in our understanding of Lynch syndrome. A recent publication estimated the prevalence of mismatch-repair gene mutations associated with Lynch syndrome at 1 in 279. Cancer risks in Lynch syndrome are significantly elevated over the general population, and it has become clear that there are distinct risk estimates depending on the gene that is mutated. New risk prediction models, such as PREMM1,2,6, have improved test characteristics over Amsterdam and Bethesda criteria for identification of mutation carriers. The Colorectal Adenoma/Carcinoma Prevention Programme (CAPP) trials have shown that aspirin is chemopreventive in Lynch syndrome. Survival in Lynch syndrome patients who develop colorectal cancer is over 90% based on results from a prospective database. Immune checkpoint inhibitor therapy has been shown to be effective in treatment of metastatic MSI-high colorectal cancer including from Lynch syndrome patients. Immunotherapy has also shown to be effective in patients with biallelic mismatch repair deficiency (BMMRD), a childhood cancer syndrome characterized by brain and gastrointestinal tumors, among others.

Sonia S. Kupfer, MD, is assistant professor of gastroenterology, director of the Gastrointestinal Cancer Risk and Prevention Clinic at the University of Chicago, and an Associate Editor of GI & Hepatology News.