The most common type of skin cancer in Hispanic patients is basal cell carcinoma, according to Maritza Perez, MD, Associate Clinical Professor of Dermatology at the Icahn School of Medicine at Mount Sinai, New York, New York. Dr. Perez reviewed skin cancer in Hispanics as part of the “Skin Issues in Latino Patients” forum at the 74th Annual Meeting of the American Academy of Dermatology (AAD)(March 4-8, 2016) in Washington, DC. The head and neck region is the most common location of BCC in Hispanics, and it is more common among Hispanic males. Squamous cell carcinomas are the second most common, and melanomas are third most common.

The mortality rate from squamous cell carcinoma is higher in Hispanic patients compared to white patients. Dr. Perez indicated that UV light exposure is a predisposing factor for these types of skin cancer, and poor sun protection practices in this population are to blame.

“Patients [in this population] do not perceive that they are prone to skin cancer,” said Dr. Perez. This erroneous perception has led to delayed diagnosis and treatment of patients in this group, which has caused increased mortality and decreased survival.

Marta Rendon, MD, director of the session at the AAD and Medical Director of The Rendon Center for Dermatology & Aesthetic Medicine, Boca Raton, Florida, noted that Latinos are the fastest growing minority population in the United States and it is estimated that they will be approximately 30% of the population by the year 2050. As a result, dermatologists must emphasize sun protection, avoidance of midday sun, and avoidance of UV radiation.

In his Cutis practical pearls, “Patient Compliance With Photoprotection,” Vincent A. DeLeo, MD, provided tips on sunscreen use. “Patients need a realistic approach to photoprotection based on their genetics, including Fitzpatrick skin type and family history . . . and lifestyle history, which should include location of residence as well as occupation and recreational pursuits,” he said. “These inquiries should lead to a frank discussion of the patient’s risk for developing photodamage and skin cancer.”

Encourage routine use of a sunscreen with a sun protection factor of 30 or higher that carries a “broad spectrum” label. “There is evidence that sunscreens prevent squamous cell carcinoma, actinic keratosis, and photoaging. Early evidence, less strong but positive, also suggests protection against basal cell carcinoma and melanoma,” Dr. DeLeo reported.

The most common type of skin cancer in Hispanic patients is basal cell carcinoma, according to Maritza Perez, MD, Associate Clinical Professor of Dermatology at the Icahn School of Medicine at Mount Sinai, New York, New York. Dr. Perez reviewed skin cancer in Hispanics as part of the “Skin Issues in Latino Patients” forum at the 74th Annual Meeting of the American Academy of Dermatology (AAD)(March 4-8, 2016) in Washington, DC. The head and neck region is the most common location of BCC in Hispanics, and it is more common among Hispanic males. Squamous cell carcinomas are the second most common, and melanomas are third most common.

The mortality rate from squamous cell carcinoma is higher in Hispanic patients compared to white patients. Dr. Perez indicated that UV light exposure is a predisposing factor for these types of skin cancer, and poor sun protection practices in this population are to blame.

“Patients [in this population] do not perceive that they are prone to skin cancer,” said Dr. Perez. This erroneous perception has led to delayed diagnosis and treatment of patients in this group, which has caused increased mortality and decreased survival.

Marta Rendon, MD, director of the session at the AAD and Medical Director of The Rendon Center for Dermatology & Aesthetic Medicine, Boca Raton, Florida, noted that Latinos are the fastest growing minority population in the United States and it is estimated that they will be approximately 30% of the population by the year 2050. As a result, dermatologists must emphasize sun protection, avoidance of midday sun, and avoidance of UV radiation.

In his Cutis practical pearls, “Patient Compliance With Photoprotection,” Vincent A. DeLeo, MD, provided tips on sunscreen use. “Patients need a realistic approach to photoprotection based on their genetics, including Fitzpatrick skin type and family history . . . and lifestyle history, which should include location of residence as well as occupation and recreational pursuits,” he said. “These inquiries should lead to a frank discussion of the patient’s risk for developing photodamage and skin cancer.”

Encourage routine use of a sunscreen with a sun protection factor of 30 or higher that carries a “broad spectrum” label. “There is evidence that sunscreens prevent squamous cell carcinoma, actinic keratosis, and photoaging. Early evidence, less strong but positive, also suggests protection against basal cell carcinoma and melanoma,” Dr. DeLeo reported.

The most common type of skin cancer in Hispanic patients is basal cell carcinoma, according to Maritza Perez, MD, Associate Clinical Professor of Dermatology at the Icahn School of Medicine at Mount Sinai, New York, New York. Dr. Perez reviewed skin cancer in Hispanics as part of the “Skin Issues in Latino Patients” forum at the 74th Annual Meeting of the American Academy of Dermatology (AAD)(March 4-8, 2016) in Washington, DC. The head and neck region is the most common location of BCC in Hispanics, and it is more common among Hispanic males. Squamous cell carcinomas are the second most common, and melanomas are third most common.

The mortality rate from squamous cell carcinoma is higher in Hispanic patients compared to white patients. Dr. Perez indicated that UV light exposure is a predisposing factor for these types of skin cancer, and poor sun protection practices in this population are to blame.

“Patients [in this population] do not perceive that they are prone to skin cancer,” said Dr. Perez. This erroneous perception has led to delayed diagnosis and treatment of patients in this group, which has caused increased mortality and decreased survival.

Marta Rendon, MD, director of the session at the AAD and Medical Director of The Rendon Center for Dermatology & Aesthetic Medicine, Boca Raton, Florida, noted that Latinos are the fastest growing minority population in the United States and it is estimated that they will be approximately 30% of the population by the year 2050. As a result, dermatologists must emphasize sun protection, avoidance of midday sun, and avoidance of UV radiation.

In his Cutis practical pearls, “Patient Compliance With Photoprotection,” Vincent A. DeLeo, MD, provided tips on sunscreen use. “Patients need a realistic approach to photoprotection based on their genetics, including Fitzpatrick skin type and family history . . . and lifestyle history, which should include location of residence as well as occupation and recreational pursuits,” he said. “These inquiries should lead to a frank discussion of the patient’s risk for developing photodamage and skin cancer.”

Encourage routine use of a sunscreen with a sun protection factor of 30 or higher that carries a “broad spectrum” label. “There is evidence that sunscreens prevent squamous cell carcinoma, actinic keratosis, and photoaging. Early evidence, less strong but positive, also suggests protection against basal cell carcinoma and melanoma,” Dr. DeLeo reported.

Obese women taking oral contraceptives had a 30-fold increased odds for cerebral venous thrombosis (CVT), compared with normal-weight women, in an unmatched case-control study of 186 CVT cases and 6,134 controls.

The association between a body-mass index of 30 kg/m² or higher and increased odds of CVT “appears to be fully attributable to a strongly increased risk in women who use oral contraceptives [OCs],” said Dr. Susanna M. Zuurbier of the Academic Medical Centre in Amsterdam, and her colleagues.

©Tina Sbrigato/iStockphoto.com

“Although the relative risks are increased substantially, the absolute risks of CVT are still small,” the researchers said. “Moreover, withholding oral contraceptives may lead to an increase in unintended pregnancies and thus the number of pregnancy-related thrombosis cases.”

After controlling for multiple variables, CVT was 2.63 times more likely to occur in obese individuals, compared with those of normal weight. When the findings were stratified by sex, a BMI greater than 30 kg/m² had no significant impact on CVT in men, but the odds rose 3.5-fold in women, the investigators reported online March 14 in JAMA Neurology (JAMA Neurol. 2016 Mar 14. doi: 10.1001/jamaneurol.2016.000100).

On further analysis, overweight and obesity had a dose-dependent impact on the odds of CVT among women who used OCs. Adjusted odds ratios were 11.87 for those with BMIs ranging from 25 kg/m² to 29 kg/m², and 29.26 for those with BMIs of 30 kg/m² or higher when compared against normal-weight women who did not use OCs. No association was found between obesity and CVT risk in women who did not use OCs, the researchers noted.

Patients with CVT were recruited in 2006-2014 from two medical centers, one in the Netherlands and the other in Switzerland. The controls were part of the Dutch Multiple Environmental and Genetic Assessment of Risk Factors for Venous Thrombosis (MEGA) study. Overall, patients with CVT were more likely to be younger than controls (median age 40 years vs. 48 years). They also were more likely than controls to be female (72% vs. 53%), users of oral contraceptives (73% vs. 24%) and have a history of cancer (9% vs. 4%).

The study was limited by several factors, including the small number of CVT cases, the lack of complete BMI data for the study population, and time difference in recruitment of cases and controls, the researchers noted, but they advised clinicians to keep the risk in mind when counseling obese women about OC use.

“Alternative methods of contraception that are not associated with thrombosis, such as an intrauterine device, might be offered to these women,” they wrote.

The study was funded by grants from the Netherlands Organisation for Scientific Research, the Dutch Thrombosis Society, the Remmert Adriaan Laan Foundation, and the Swiss Heart Foundation. Study coauthor Dr. Marcel Arnold disclosed receiving honoraria for giving lectures and serving on advisory boards for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Covidien.

Obese women taking oral contraceptives had a 30-fold increased odds for cerebral venous thrombosis (CVT), compared with normal-weight women, in an unmatched case-control study of 186 CVT cases and 6,134 controls.

The association between a body-mass index of 30 kg/m² or higher and increased odds of CVT “appears to be fully attributable to a strongly increased risk in women who use oral contraceptives [OCs],” said Dr. Susanna M. Zuurbier of the Academic Medical Centre in Amsterdam, and her colleagues.

©Tina Sbrigato/iStockphoto.com

“Although the relative risks are increased substantially, the absolute risks of CVT are still small,” the researchers said. “Moreover, withholding oral contraceptives may lead to an increase in unintended pregnancies and thus the number of pregnancy-related thrombosis cases.”

After controlling for multiple variables, CVT was 2.63 times more likely to occur in obese individuals, compared with those of normal weight. When the findings were stratified by sex, a BMI greater than 30 kg/m² had no significant impact on CVT in men, but the odds rose 3.5-fold in women, the investigators reported online March 14 in JAMA Neurology (JAMA Neurol. 2016 Mar 14. doi: 10.1001/jamaneurol.2016.000100).

On further analysis, overweight and obesity had a dose-dependent impact on the odds of CVT among women who used OCs. Adjusted odds ratios were 11.87 for those with BMIs ranging from 25 kg/m² to 29 kg/m², and 29.26 for those with BMIs of 30 kg/m² or higher when compared against normal-weight women who did not use OCs. No association was found between obesity and CVT risk in women who did not use OCs, the researchers noted.

Patients with CVT were recruited in 2006-2014 from two medical centers, one in the Netherlands and the other in Switzerland. The controls were part of the Dutch Multiple Environmental and Genetic Assessment of Risk Factors for Venous Thrombosis (MEGA) study. Overall, patients with CVT were more likely to be younger than controls (median age 40 years vs. 48 years). They also were more likely than controls to be female (72% vs. 53%), users of oral contraceptives (73% vs. 24%) and have a history of cancer (9% vs. 4%).

The study was limited by several factors, including the small number of CVT cases, the lack of complete BMI data for the study population, and time difference in recruitment of cases and controls, the researchers noted, but they advised clinicians to keep the risk in mind when counseling obese women about OC use.

“Alternative methods of contraception that are not associated with thrombosis, such as an intrauterine device, might be offered to these women,” they wrote.

The study was funded by grants from the Netherlands Organisation for Scientific Research, the Dutch Thrombosis Society, the Remmert Adriaan Laan Foundation, and the Swiss Heart Foundation. Study coauthor Dr. Marcel Arnold disclosed receiving honoraria for giving lectures and serving on advisory boards for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Covidien.

Obese women taking oral contraceptives had a 30-fold increased odds for cerebral venous thrombosis (CVT), compared with normal-weight women, in an unmatched case-control study of 186 CVT cases and 6,134 controls.

The association between a body-mass index of 30 kg/m² or higher and increased odds of CVT “appears to be fully attributable to a strongly increased risk in women who use oral contraceptives [OCs],” said Dr. Susanna M. Zuurbier of the Academic Medical Centre in Amsterdam, and her colleagues.

©Tina Sbrigato/iStockphoto.com

“Although the relative risks are increased substantially, the absolute risks of CVT are still small,” the researchers said. “Moreover, withholding oral contraceptives may lead to an increase in unintended pregnancies and thus the number of pregnancy-related thrombosis cases.”

After controlling for multiple variables, CVT was 2.63 times more likely to occur in obese individuals, compared with those of normal weight. When the findings were stratified by sex, a BMI greater than 30 kg/m² had no significant impact on CVT in men, but the odds rose 3.5-fold in women, the investigators reported online March 14 in JAMA Neurology (JAMA Neurol. 2016 Mar 14. doi: 10.1001/jamaneurol.2016.000100).

On further analysis, overweight and obesity had a dose-dependent impact on the odds of CVT among women who used OCs. Adjusted odds ratios were 11.87 for those with BMIs ranging from 25 kg/m² to 29 kg/m², and 29.26 for those with BMIs of 30 kg/m² or higher when compared against normal-weight women who did not use OCs. No association was found between obesity and CVT risk in women who did not use OCs, the researchers noted.

Patients with CVT were recruited in 2006-2014 from two medical centers, one in the Netherlands and the other in Switzerland. The controls were part of the Dutch Multiple Environmental and Genetic Assessment of Risk Factors for Venous Thrombosis (MEGA) study. Overall, patients with CVT were more likely to be younger than controls (median age 40 years vs. 48 years). They also were more likely than controls to be female (72% vs. 53%), users of oral contraceptives (73% vs. 24%) and have a history of cancer (9% vs. 4%).

The study was limited by several factors, including the small number of CVT cases, the lack of complete BMI data for the study population, and time difference in recruitment of cases and controls, the researchers noted, but they advised clinicians to keep the risk in mind when counseling obese women about OC use.

“Alternative methods of contraception that are not associated with thrombosis, such as an intrauterine device, might be offered to these women,” they wrote.

The study was funded by grants from the Netherlands Organisation for Scientific Research, the Dutch Thrombosis Society, the Remmert Adriaan Laan Foundation, and the Swiss Heart Foundation. Study coauthor Dr. Marcel Arnold disclosed receiving honoraria for giving lectures and serving on advisory boards for Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Covidien.

LOS ANGELES – Medtronic’s Reveal LINQ implantable loop recorders misidentified 84% of rhythm anomalies as atrial fibrillation in 52 stroke patients at Emory University in Atlanta, according to a presentation at the International Stroke Conference.

Two electrophysiologists reviewed a random sample of 166 rhythm strips from those patients that were identified by Reveal as atrial fibrillation (AF) over a 2-month period; 140 (84%) were false positives. Eighty (57%) of the false positives were premature atrial complexes, 31 (22%) were due to T wave over-sensing, 14 (10%) to noise, 7 (5%) to premature ventricular complexes, 4 (2.9%) to under-sensing, and 4 (2.9%) to sinus arrhythmias.

There wasn’t a mix-and-match of true and false positives in the same patient; false and true positives were consistent in patients over the study period.

The take-home message from the study is that the high sensitivity of Medtronic’s implantable loop recorders means that they are good at detecting possible AF, but their findings must be reviewed and confirmed before being acted upon.

“There are high rates of false positives, but the results can be easily adjudicated by electrophysiologists as evidenced by our observer agreement,” which was 100%. “These strips need to be adjudicated by somebody, and not taken at face value,” said investigator Dr. Spencer Maddox, an Emory resident.

The devices look mainly at RR intervals and the presence or absence of P waves. Runs of 2 minutes are required for AF. One of the issues in the study was that T waves were identified as QRS complexes, which changed the RR interval and trigged the device to report AF, he said.

Medtronic could reduce the false positive rate by, for instance, extending the run required for AF, but it would be a bad idea. “The goal here is to not miss atrial fibrillation,” Dr. Maddox said. “There are false positives, but as long as you go back and reread, I think that’s fine. I wouldn’t mess with the sensitivity of the device.”

The company said the same thing when asked for comment on the study.

“The AF detection algorithm ... is tuned to favor sensitivity because manual review can subsequently rule out any false positives. This is one reason it is important to have trained cardiologists or electrophysiologists involved in reviewing reports of irregular heart rhythms to determine a diagnosis of AF,” said Medtronic spokesman Ryan Mathre, who also noted that company data suggest a lower false positive rate (Cerebrovasc Dis. 2015;40:175-81).

Even so, confirmation doesn’t always happen, “and that’s the scary part. In practice almost all the time,” the report comes in “and it’s acted on,” said Dr. Robert Hart, a neurology professor at McMaster University in Hamilton, Ont., and comoderator of the study presentation.

The Emory patients were all recovering from ischemic strokes or TIAs. They were about 70 years old on average, about 60% were men, and almost all were white. A total of 38 had implantable loop recorders for cryptogenic strokes; the devices detected true AF in 4 (11%) after a mean of 92 days. Early Holter monitoring missed it.

Emory generally prescribes anticoagulants if AF is confirmed, but, as several audience members noted, the burden of AF that requires anticoagulation is unclear. “It’s an area with a lot of thought now, but no good answers,” Dr. Maddox said at the conference, sponsored by the American Heart Association.

The investigators had no disclosures, and there was no outside funding for the work.

[email protected]

LOS ANGELES – Medtronic’s Reveal LINQ implantable loop recorders misidentified 84% of rhythm anomalies as atrial fibrillation in 52 stroke patients at Emory University in Atlanta, according to a presentation at the International Stroke Conference.

Two electrophysiologists reviewed a random sample of 166 rhythm strips from those patients that were identified by Reveal as atrial fibrillation (AF) over a 2-month period; 140 (84%) were false positives. Eighty (57%) of the false positives were premature atrial complexes, 31 (22%) were due to T wave over-sensing, 14 (10%) to noise, 7 (5%) to premature ventricular complexes, 4 (2.9%) to under-sensing, and 4 (2.9%) to sinus arrhythmias.

There wasn’t a mix-and-match of true and false positives in the same patient; false and true positives were consistent in patients over the study period.

The take-home message from the study is that the high sensitivity of Medtronic’s implantable loop recorders means that they are good at detecting possible AF, but their findings must be reviewed and confirmed before being acted upon.

“There are high rates of false positives, but the results can be easily adjudicated by electrophysiologists as evidenced by our observer agreement,” which was 100%. “These strips need to be adjudicated by somebody, and not taken at face value,” said investigator Dr. Spencer Maddox, an Emory resident.

The devices look mainly at RR intervals and the presence or absence of P waves. Runs of 2 minutes are required for AF. One of the issues in the study was that T waves were identified as QRS complexes, which changed the RR interval and trigged the device to report AF, he said.

Medtronic could reduce the false positive rate by, for instance, extending the run required for AF, but it would be a bad idea. “The goal here is to not miss atrial fibrillation,” Dr. Maddox said. “There are false positives, but as long as you go back and reread, I think that’s fine. I wouldn’t mess with the sensitivity of the device.”

The company said the same thing when asked for comment on the study.

“The AF detection algorithm ... is tuned to favor sensitivity because manual review can subsequently rule out any false positives. This is one reason it is important to have trained cardiologists or electrophysiologists involved in reviewing reports of irregular heart rhythms to determine a diagnosis of AF,” said Medtronic spokesman Ryan Mathre, who also noted that company data suggest a lower false positive rate (Cerebrovasc Dis. 2015;40:175-81).

Even so, confirmation doesn’t always happen, “and that’s the scary part. In practice almost all the time,” the report comes in “and it’s acted on,” said Dr. Robert Hart, a neurology professor at McMaster University in Hamilton, Ont., and comoderator of the study presentation.

The Emory patients were all recovering from ischemic strokes or TIAs. They were about 70 years old on average, about 60% were men, and almost all were white. A total of 38 had implantable loop recorders for cryptogenic strokes; the devices detected true AF in 4 (11%) after a mean of 92 days. Early Holter monitoring missed it.

Emory generally prescribes anticoagulants if AF is confirmed, but, as several audience members noted, the burden of AF that requires anticoagulation is unclear. “It’s an area with a lot of thought now, but no good answers,” Dr. Maddox said at the conference, sponsored by the American Heart Association.

The investigators had no disclosures, and there was no outside funding for the work.

[email protected]

LOS ANGELES – Medtronic’s Reveal LINQ implantable loop recorders misidentified 84% of rhythm anomalies as atrial fibrillation in 52 stroke patients at Emory University in Atlanta, according to a presentation at the International Stroke Conference.

Two electrophysiologists reviewed a random sample of 166 rhythm strips from those patients that were identified by Reveal as atrial fibrillation (AF) over a 2-month period; 140 (84%) were false positives. Eighty (57%) of the false positives were premature atrial complexes, 31 (22%) were due to T wave over-sensing, 14 (10%) to noise, 7 (5%) to premature ventricular complexes, 4 (2.9%) to under-sensing, and 4 (2.9%) to sinus arrhythmias.

There wasn’t a mix-and-match of true and false positives in the same patient; false and true positives were consistent in patients over the study period.

The take-home message from the study is that the high sensitivity of Medtronic’s implantable loop recorders means that they are good at detecting possible AF, but their findings must be reviewed and confirmed before being acted upon.

“There are high rates of false positives, but the results can be easily adjudicated by electrophysiologists as evidenced by our observer agreement,” which was 100%. “These strips need to be adjudicated by somebody, and not taken at face value,” said investigator Dr. Spencer Maddox, an Emory resident.

The devices look mainly at RR intervals and the presence or absence of P waves. Runs of 2 minutes are required for AF. One of the issues in the study was that T waves were identified as QRS complexes, which changed the RR interval and trigged the device to report AF, he said.

Medtronic could reduce the false positive rate by, for instance, extending the run required for AF, but it would be a bad idea. “The goal here is to not miss atrial fibrillation,” Dr. Maddox said. “There are false positives, but as long as you go back and reread, I think that’s fine. I wouldn’t mess with the sensitivity of the device.”

The company said the same thing when asked for comment on the study.

“The AF detection algorithm ... is tuned to favor sensitivity because manual review can subsequently rule out any false positives. This is one reason it is important to have trained cardiologists or electrophysiologists involved in reviewing reports of irregular heart rhythms to determine a diagnosis of AF,” said Medtronic spokesman Ryan Mathre, who also noted that company data suggest a lower false positive rate (Cerebrovasc Dis. 2015;40:175-81).

Even so, confirmation doesn’t always happen, “and that’s the scary part. In practice almost all the time,” the report comes in “and it’s acted on,” said Dr. Robert Hart, a neurology professor at McMaster University in Hamilton, Ont., and comoderator of the study presentation.

The Emory patients were all recovering from ischemic strokes or TIAs. They were about 70 years old on average, about 60% were men, and almost all were white. A total of 38 had implantable loop recorders for cryptogenic strokes; the devices detected true AF in 4 (11%) after a mean of 92 days. Early Holter monitoring missed it.

Emory generally prescribes anticoagulants if AF is confirmed, but, as several audience members noted, the burden of AF that requires anticoagulation is unclear. “It’s an area with a lot of thought now, but no good answers,” Dr. Maddox said at the conference, sponsored by the American Heart Association.

The investigators had no disclosures, and there was no outside funding for the work.

[email protected]

Swapping lenalidomide for thalidomide in a standard regimen for transplant-ineligible patients with untreated multiple myeloma did not improve efficacy, but the toxicity profile may favor the use of lenalidomide in a maintenance regimen, results of a randomized trial suggest.

Among patients with previously untreated multiple myeloma who were not eligible for autologous stem cell transplant, neither median progression-free survival (PFS) nor overall survival (OS) were significantly different for patients treated with either melphalan, prednisone, and thalidomide (MPT-T) followed by thalidomide maintenance, or with the same regimen with lenalidomide (Revlimid) substituted for thalidomide (MPR-R), reported Dr. Sonja Zweegman of Vrije University Medical Center in Amsterdam.

“MPR-R has no advantage over MPT-T with respect to response rate, PFS, and OS. However, the use of thalidomide as maintenance therapy was associated with a high rate of clinically significant neuropathy and is therefore not preferred for maintenance strategies,” they wrote (Blood 2016;127[9];1109-16).

The investigators randomly assigned 637 transplant-ineligible patients with newly-diagnosed multiple myeloma to receive nine 4-week cycles of either MPT-T (318 patients) or MPR-R (319 patients). At 36 months’ median follow-up, median PFS, the primary endpoint, was 20 months for patients treated with MPT-T, compared with 23 months for those treated with MPR-R. This translated into a hazard ratio (HR) of 0.87, P = .12).

The overall response rates were 81% for MPT-T and 84% for MPR-R. Very good partial responses or better were seen in 47% and 45%, of patients, respectively. The complete response rate with MPT-T was 10%, compared with 13% for MPR-R. Median time to response and time to maximum response were similar between the arms.

OS at 2, 3, and 4 years in the MPT-T and MPR-R arms was 73% vs. 84%, 64% vs 69%, and 52% vs. 56%, respectively. These differences were not statistically significant.

The proportion of patients with one or more grade 3 or 4 adverse events was 81% with thalidomide and 86% with lenalidomide.

The investigators noted, however, that there was a high rate of discontinuation during induction therapy in each arm, with 49% of those starting on MPT-T and 41% of those starting on MPR-R halting therapy. Most of the patients who discontinued were older than age 75. Early treatment deaths (within three cycles) occurred in 13 patients on MPT-T, and 8 on MPR-R.

Among patients who started on maintenance therapy, significantly more patients on thalidomide had to discontinue thalidomide than did patients who started on lenalidomide maintenance (60% vs, 17%, P = .017).

The primary reason for the higher rate of discontinuation of MPT-T maintenance was neuropathy, which occurred in 87% of the discontinuations in this study arm, compared with 3% of those in the lenalidomide arm. Neuropathy of at least grade 3 was 16% in the MPT-T arm vs. 2% in MPR-R, resulting in a significantly shorter duration of maintenance therapy (5 vs. 17 months in MPR-R), irrespective of age.

Hematologic toxicities were higher in the MPR-R group, especially grades 3 and 4 neutropenia (64% vs 27%), but this did not translate into a higher clinical infection rate, and the toxicities were manageable in older patients, the investigators reported.

Swapping lenalidomide for thalidomide in a standard regimen for transplant-ineligible patients with untreated multiple myeloma did not improve efficacy, but the toxicity profile may favor the use of lenalidomide in a maintenance regimen, results of a randomized trial suggest.

Among patients with previously untreated multiple myeloma who were not eligible for autologous stem cell transplant, neither median progression-free survival (PFS) nor overall survival (OS) were significantly different for patients treated with either melphalan, prednisone, and thalidomide (MPT-T) followed by thalidomide maintenance, or with the same regimen with lenalidomide (Revlimid) substituted for thalidomide (MPR-R), reported Dr. Sonja Zweegman of Vrije University Medical Center in Amsterdam.

“MPR-R has no advantage over MPT-T with respect to response rate, PFS, and OS. However, the use of thalidomide as maintenance therapy was associated with a high rate of clinically significant neuropathy and is therefore not preferred for maintenance strategies,” they wrote (Blood 2016;127[9];1109-16).

The investigators randomly assigned 637 transplant-ineligible patients with newly-diagnosed multiple myeloma to receive nine 4-week cycles of either MPT-T (318 patients) or MPR-R (319 patients). At 36 months’ median follow-up, median PFS, the primary endpoint, was 20 months for patients treated with MPT-T, compared with 23 months for those treated with MPR-R. This translated into a hazard ratio (HR) of 0.87, P = .12).

The overall response rates were 81% for MPT-T and 84% for MPR-R. Very good partial responses or better were seen in 47% and 45%, of patients, respectively. The complete response rate with MPT-T was 10%, compared with 13% for MPR-R. Median time to response and time to maximum response were similar between the arms.

OS at 2, 3, and 4 years in the MPT-T and MPR-R arms was 73% vs. 84%, 64% vs 69%, and 52% vs. 56%, respectively. These differences were not statistically significant.

The proportion of patients with one or more grade 3 or 4 adverse events was 81% with thalidomide and 86% with lenalidomide.

The investigators noted, however, that there was a high rate of discontinuation during induction therapy in each arm, with 49% of those starting on MPT-T and 41% of those starting on MPR-R halting therapy. Most of the patients who discontinued were older than age 75. Early treatment deaths (within three cycles) occurred in 13 patients on MPT-T, and 8 on MPR-R.

Among patients who started on maintenance therapy, significantly more patients on thalidomide had to discontinue thalidomide than did patients who started on lenalidomide maintenance (60% vs, 17%, P = .017).

The primary reason for the higher rate of discontinuation of MPT-T maintenance was neuropathy, which occurred in 87% of the discontinuations in this study arm, compared with 3% of those in the lenalidomide arm. Neuropathy of at least grade 3 was 16% in the MPT-T arm vs. 2% in MPR-R, resulting in a significantly shorter duration of maintenance therapy (5 vs. 17 months in MPR-R), irrespective of age.

Hematologic toxicities were higher in the MPR-R group, especially grades 3 and 4 neutropenia (64% vs 27%), but this did not translate into a higher clinical infection rate, and the toxicities were manageable in older patients, the investigators reported.

Swapping lenalidomide for thalidomide in a standard regimen for transplant-ineligible patients with untreated multiple myeloma did not improve efficacy, but the toxicity profile may favor the use of lenalidomide in a maintenance regimen, results of a randomized trial suggest.

Among patients with previously untreated multiple myeloma who were not eligible for autologous stem cell transplant, neither median progression-free survival (PFS) nor overall survival (OS) were significantly different for patients treated with either melphalan, prednisone, and thalidomide (MPT-T) followed by thalidomide maintenance, or with the same regimen with lenalidomide (Revlimid) substituted for thalidomide (MPR-R), reported Dr. Sonja Zweegman of Vrije University Medical Center in Amsterdam.

“MPR-R has no advantage over MPT-T with respect to response rate, PFS, and OS. However, the use of thalidomide as maintenance therapy was associated with a high rate of clinically significant neuropathy and is therefore not preferred for maintenance strategies,” they wrote (Blood 2016;127[9];1109-16).

The investigators randomly assigned 637 transplant-ineligible patients with newly-diagnosed multiple myeloma to receive nine 4-week cycles of either MPT-T (318 patients) or MPR-R (319 patients). At 36 months’ median follow-up, median PFS, the primary endpoint, was 20 months for patients treated with MPT-T, compared with 23 months for those treated with MPR-R. This translated into a hazard ratio (HR) of 0.87, P = .12).

The overall response rates were 81% for MPT-T and 84% for MPR-R. Very good partial responses or better were seen in 47% and 45%, of patients, respectively. The complete response rate with MPT-T was 10%, compared with 13% for MPR-R. Median time to response and time to maximum response were similar between the arms.

OS at 2, 3, and 4 years in the MPT-T and MPR-R arms was 73% vs. 84%, 64% vs 69%, and 52% vs. 56%, respectively. These differences were not statistically significant.

The proportion of patients with one or more grade 3 or 4 adverse events was 81% with thalidomide and 86% with lenalidomide.

The investigators noted, however, that there was a high rate of discontinuation during induction therapy in each arm, with 49% of those starting on MPT-T and 41% of those starting on MPR-R halting therapy. Most of the patients who discontinued were older than age 75. Early treatment deaths (within three cycles) occurred in 13 patients on MPT-T, and 8 on MPR-R.

Among patients who started on maintenance therapy, significantly more patients on thalidomide had to discontinue thalidomide than did patients who started on lenalidomide maintenance (60% vs, 17%, P = .017).

The primary reason for the higher rate of discontinuation of MPT-T maintenance was neuropathy, which occurred in 87% of the discontinuations in this study arm, compared with 3% of those in the lenalidomide arm. Neuropathy of at least grade 3 was 16% in the MPT-T arm vs. 2% in MPR-R, resulting in a significantly shorter duration of maintenance therapy (5 vs. 17 months in MPR-R), irrespective of age.

Hematologic toxicities were higher in the MPR-R group, especially grades 3 and 4 neutropenia (64% vs 27%), but this did not translate into a higher clinical infection rate, and the toxicities were manageable in older patients, the investigators reported.

Last year, Congress passed legislation to permanently eliminate the Sustainable Growth Rate (SGR) formula, created in 1997 and designed to hold Medicare Part B or outpatient spending under control. Allowing the SGR to go into effect would have severely cut physician reimbursements in recent years, but Congress passed legislation each year to temporarily avert these cuts (also known annually as the “doc fix”). In search of a permanent solution, the passage of bipartisan legislation permanently repealing the SGR in 2015 was hailed as a way to ensure more certainty around the future of Medicare payments for physicians.

This legislation (H.R. 2, 114th Congress), sponsored by Rep. Michael C. Burgess (R-Texas) and entitled “Medicare Access and CHIP Reauthorization Act of 2015,” or MACRA, does much more than simply remove the SGR’s threat of broader Medicare payment cuts. The law changes the ways physicians are reimbursed by Medicare and continues to shift our healthcare system away from volume-based reimbursements and toward a value-based payment system.

What Is MIPS?

MACRA creates two value-based payment tracks for physicians. The first, the Merit-Based Incentive Payment System (MIPS), is closer to the old fee-for-service model of reimbursement. However, MIPS takes into account both volume and quality (i.e., payment is adjusted based on physician-quality scores). These physician-specific scores broaden the scope of quality measurement by including new measures related to resource utilization, electronic health record (EHR) use, and clinical improvement practices, along with the traditional clinical quality markers.

Under MIPS, the current Physician Quality Reporting System (PQRS), EHR Incentive Program, and Physician Value-Based Modifier all will be integrated into this single-payment adjustment.

The range of potential payment adjustments based on a physician’s MIPS score grows each year through 2022 (in 2022, adjustments can range from +9% to -9%). The program is budget neutral, which means that increases in payments to high-scoring providers will be offset by decreases in payments to low-scoring providers. For 2019 to 2024, there also will be an additional payment adjustment given to the highest MIPS performers for exceptional performance.

A benefit of MIPS is that it will streamline the various quality-reporting programs currently in place into one single program and does not ask physicians to assume any additional financial risk related to outcomes when taking care of patients. However, the particulars of how the MIPS score will be calculated are yet to be determined, and much of the utility and palatability of this score will depend on the chosen metrics. The goal of these metrics should be that they are meaningful, valid, and attributable to specific providers.

What Are APMs?

The other payment option MACRA provides for physicians allows them to opt out of MIPS and participate in the Alternative Payment Models (APMs) track. To incentivize physicians to take part in this riskier track, providers taking part in APMs will receive some extra money for their participation: a 5% annual lump sum bonus on reimbursement payments. To clarify, qualifying APMs are those where providers take on “more than nominal” financial risk, report on their quality measures, and use certified EHR technology.

To qualify as a participant in an APM (for example, the Medicare Shared Savings Program), providers must hit a threshold for percentage of total revenue received or percentage of patients from qualifying APMs. This threshold will increase over time. For example, from 2019 to 2020, providers must obtain at least 25% of their Medicare revenue or patients via APMs, whereas in 2023, 75% of their Medicare revenue or \ patients will need to come from APMs.

Providers will benefit from the increased reimbursement offered if they participate in APMs. There also is funding allocated in MACRA to help develop quality measures, with a call for physician leads to develop quality standards. This payment model, however, does come with increased financial risk for the provider contingent on patient outcomes. In addition, it may be difficult for all providers to hit the thresholds for participation.

 

Stick with MIPS? Or Take the Plunge with APM?

How MACRA affects you will depend a lot on the practice environment. As described above, MACRA is designed to move physicians into risk-based payment structures if possible. If possible, or otherwise, to simplify the current fee-for-service mechanism of payment by consolidating various Medicare pay-for-performance programs.

Let’s look at a few scenarios:

Hospitalist A works for a physician group that assumes risk for patients in a MACRA-approved APM and sees only those inpatients as opposed to unassigned patients. Therefore, almost all of hospitalist A’s patients are covered by risk-based contracts, and hospitalist A might be well positioned for the new APM structure.

Hospitalist B works for a group, or a university, and sees whatever patients are admitted to the hospital. Hospitalist B’s eligibility to participate in the APM will depend on the percentage of patients in alternative payment models in their market. If hospitalist B’s market has many Medicare accountable care organizations, and Medicaid and the commercial insurers compensate through a risk-sharing model, hospitalist B might reach the threshold. This is more accidental than planned, however, and hospitalist B might not be able to consistently hit this threshold year after year.

In addition, just working within the model will probably not be enough to qualify. Hospitalist B will need to also take on “more than nominal risk” as a participant in the model. In an employed academic setting, where the hospital is taking on risk as part of an APM, it is unlikely hospitalist B will qualify just by virtue of hospital employment. Hospitalist B must also meet/exceed the patient or payment thresholds under the model.

Bottom line: Given the current situation, we expect many hospitalists will likely be required to participate in MIPS and not qualify for APMs. Understanding the details and expectations now will help them be successful in the future.

Is MACRA Good for Hospitalists?

Most of organized medicine is happy to be free from the annual threat of reimbursement cuts. In addition, the new law might streamline quality reporting. But the specific upside depends on your perspective.

With APMs, a hospitalist might enjoy more upside potential, particularly for high-quality work and EHR use. However, whether it is realistic for most hospitalists to even participate in the model depends on many factors, as described previously, and SHM is advocating for the law to be implemented in ways that will more readily accommodate hospitalist practice and employment structures.

For example, the SHM Public Policy Committee has provided the Centers for Medicare & Medicaid Services (CMS) with realistic options for implementing the APM framework that would allow hospitalist B in the above example to qualify as an APM participant.

With MIPS, the benefit to hospitalists depends a fair amount on the way the law is implemented: how quality reporting happens, what metrics will count as quality improvement efforts, and how utilization of EHRs is measured.

What Issues Should Hospitalists Be Aware Of?

As MACRA is further developed, the main issue for hospitalists will be to ensure fairness in assessing quality and incentive payments. As previously encountered with quality reporting, hospitalists are not differentiated clearly from outpatient providers. As a result, they could suffer from the comparison of their quality outcomes for their sicker hospitalized patients to the patients cared for in a typical primary-care internal medicine practice. This inaccurate comparison poses problems in both models.

A potential solution would be a hospitalist-specific billing code, which would make it easier to identify hospitalists. SHM applied for and advocated for the approval of such a billing code and the request was recently approved by CMS.

 

In addition, as hospitalists mostly work in groups with shift-based schedules, thus sharing care of patients, individual identifiers may not be as significant as possibly looking at hospital, system, or team-based metrics. Using facility performance measures for both clinical quality and performance improvement—where hospitalists can opt to align with their hospital, which is already reporting quality outcomes—might be one way out of this conundrum. It would take into account the type of facility-level quality improvement work many hospitalists participate in. This also would decrease reporting burden for hospitalist groups.

SHM has advocated for this solution and was able to ensure this concept was included in the law; however, it is unclear when or how CMS will implement it.

To summarize, looking good in quality reporting will continue to be a challenge for hospitalists. It will be critical to keep pressure on CMS to implement solutions that account for the unique situation of our specialty.

Another issue to be aware of is the ability of hospitalists to participate in APMs. As with other facility-based providers, hospitalists have little control over whether their facility participates in an APM. Ways to ensure hospitalists can reach thresholds for participation could include allowing the various APMs that hospitalist patients are aligned with count toward an individual hospitalists’ APM participation total—a solution that SHM is advocating for Medicare to include in the APM framework.

What’s Next?

Much remains to be solidified regarding implementation of MACRA, despite the fact it goes live in a few short years (see Figure 1). CMS has asked for comments and stakeholder input regarding MIPS and APMs, and it will be releasing the first round of rules around MACRA this year.

SHM is actively working with CMS to ensure this legislation will reflect the work we are doing as hospitalists to provide high-quality clinical care for our patients and enhance the performance of our hospitals and health system. TH

---

Dr. Doctoroff is a hospitalist at Beth Israel Deaconess Medical Center and an instructor of medicine at Harvard Medical School in Boston. Dr. Dutta is a hospitalist at Rush University Medical Center and an assistant professor of medicine at Rush Medical College in Chicago. Both are members of the SHM Public Policy Committee.

Last year, Congress passed legislation to permanently eliminate the Sustainable Growth Rate (SGR) formula, created in 1997 and designed to hold Medicare Part B or outpatient spending under control. Allowing the SGR to go into effect would have severely cut physician reimbursements in recent years, but Congress passed legislation each year to temporarily avert these cuts (also known annually as the “doc fix”). In search of a permanent solution, the passage of bipartisan legislation permanently repealing the SGR in 2015 was hailed as a way to ensure more certainty around the future of Medicare payments for physicians.

This legislation (H.R. 2, 114th Congress), sponsored by Rep. Michael C. Burgess (R-Texas) and entitled “Medicare Access and CHIP Reauthorization Act of 2015,” or MACRA, does much more than simply remove the SGR’s threat of broader Medicare payment cuts. The law changes the ways physicians are reimbursed by Medicare and continues to shift our healthcare system away from volume-based reimbursements and toward a value-based payment system.

What Is MIPS?

MACRA creates two value-based payment tracks for physicians. The first, the Merit-Based Incentive Payment System (MIPS), is closer to the old fee-for-service model of reimbursement. However, MIPS takes into account both volume and quality (i.e., payment is adjusted based on physician-quality scores). These physician-specific scores broaden the scope of quality measurement by including new measures related to resource utilization, electronic health record (EHR) use, and clinical improvement practices, along with the traditional clinical quality markers.

Under MIPS, the current Physician Quality Reporting System (PQRS), EHR Incentive Program, and Physician Value-Based Modifier all will be integrated into this single-payment adjustment.

The range of potential payment adjustments based on a physician’s MIPS score grows each year through 2022 (in 2022, adjustments can range from +9% to -9%). The program is budget neutral, which means that increases in payments to high-scoring providers will be offset by decreases in payments to low-scoring providers. For 2019 to 2024, there also will be an additional payment adjustment given to the highest MIPS performers for exceptional performance.

A benefit of MIPS is that it will streamline the various quality-reporting programs currently in place into one single program and does not ask physicians to assume any additional financial risk related to outcomes when taking care of patients. However, the particulars of how the MIPS score will be calculated are yet to be determined, and much of the utility and palatability of this score will depend on the chosen metrics. The goal of these metrics should be that they are meaningful, valid, and attributable to specific providers.

What Are APMs?

The other payment option MACRA provides for physicians allows them to opt out of MIPS and participate in the Alternative Payment Models (APMs) track. To incentivize physicians to take part in this riskier track, providers taking part in APMs will receive some extra money for their participation: a 5% annual lump sum bonus on reimbursement payments. To clarify, qualifying APMs are those where providers take on “more than nominal” financial risk, report on their quality measures, and use certified EHR technology.

To qualify as a participant in an APM (for example, the Medicare Shared Savings Program), providers must hit a threshold for percentage of total revenue received or percentage of patients from qualifying APMs. This threshold will increase over time. For example, from 2019 to 2020, providers must obtain at least 25% of their Medicare revenue or patients via APMs, whereas in 2023, 75% of their Medicare revenue or \ patients will need to come from APMs.

Providers will benefit from the increased reimbursement offered if they participate in APMs. There also is funding allocated in MACRA to help develop quality measures, with a call for physician leads to develop quality standards. This payment model, however, does come with increased financial risk for the provider contingent on patient outcomes. In addition, it may be difficult for all providers to hit the thresholds for participation.

 

Stick with MIPS? Or Take the Plunge with APM?

How MACRA affects you will depend a lot on the practice environment. As described above, MACRA is designed to move physicians into risk-based payment structures if possible. If possible, or otherwise, to simplify the current fee-for-service mechanism of payment by consolidating various Medicare pay-for-performance programs.

Let’s look at a few scenarios:

Hospitalist A works for a physician group that assumes risk for patients in a MACRA-approved APM and sees only those inpatients as opposed to unassigned patients. Therefore, almost all of hospitalist A’s patients are covered by risk-based contracts, and hospitalist A might be well positioned for the new APM structure.

Hospitalist B works for a group, or a university, and sees whatever patients are admitted to the hospital. Hospitalist B’s eligibility to participate in the APM will depend on the percentage of patients in alternative payment models in their market. If hospitalist B’s market has many Medicare accountable care organizations, and Medicaid and the commercial insurers compensate through a risk-sharing model, hospitalist B might reach the threshold. This is more accidental than planned, however, and hospitalist B might not be able to consistently hit this threshold year after year.

In addition, just working within the model will probably not be enough to qualify. Hospitalist B will need to also take on “more than nominal risk” as a participant in the model. In an employed academic setting, where the hospital is taking on risk as part of an APM, it is unlikely hospitalist B will qualify just by virtue of hospital employment. Hospitalist B must also meet/exceed the patient or payment thresholds under the model.

Bottom line: Given the current situation, we expect many hospitalists will likely be required to participate in MIPS and not qualify for APMs. Understanding the details and expectations now will help them be successful in the future.

Is MACRA Good for Hospitalists?

Most of organized medicine is happy to be free from the annual threat of reimbursement cuts. In addition, the new law might streamline quality reporting. But the specific upside depends on your perspective.

With APMs, a hospitalist might enjoy more upside potential, particularly for high-quality work and EHR use. However, whether it is realistic for most hospitalists to even participate in the model depends on many factors, as described previously, and SHM is advocating for the law to be implemented in ways that will more readily accommodate hospitalist practice and employment structures.

For example, the SHM Public Policy Committee has provided the Centers for Medicare & Medicaid Services (CMS) with realistic options for implementing the APM framework that would allow hospitalist B in the above example to qualify as an APM participant.

With MIPS, the benefit to hospitalists depends a fair amount on the way the law is implemented: how quality reporting happens, what metrics will count as quality improvement efforts, and how utilization of EHRs is measured.

What Issues Should Hospitalists Be Aware Of?

As MACRA is further developed, the main issue for hospitalists will be to ensure fairness in assessing quality and incentive payments. As previously encountered with quality reporting, hospitalists are not differentiated clearly from outpatient providers. As a result, they could suffer from the comparison of their quality outcomes for their sicker hospitalized patients to the patients cared for in a typical primary-care internal medicine practice. This inaccurate comparison poses problems in both models.

A potential solution would be a hospitalist-specific billing code, which would make it easier to identify hospitalists. SHM applied for and advocated for the approval of such a billing code and the request was recently approved by CMS.

 

In addition, as hospitalists mostly work in groups with shift-based schedules, thus sharing care of patients, individual identifiers may not be as significant as possibly looking at hospital, system, or team-based metrics. Using facility performance measures for both clinical quality and performance improvement—where hospitalists can opt to align with their hospital, which is already reporting quality outcomes—might be one way out of this conundrum. It would take into account the type of facility-level quality improvement work many hospitalists participate in. This also would decrease reporting burden for hospitalist groups.

SHM has advocated for this solution and was able to ensure this concept was included in the law; however, it is unclear when or how CMS will implement it.

To summarize, looking good in quality reporting will continue to be a challenge for hospitalists. It will be critical to keep pressure on CMS to implement solutions that account for the unique situation of our specialty.

Another issue to be aware of is the ability of hospitalists to participate in APMs. As with other facility-based providers, hospitalists have little control over whether their facility participates in an APM. Ways to ensure hospitalists can reach thresholds for participation could include allowing the various APMs that hospitalist patients are aligned with count toward an individual hospitalists’ APM participation total—a solution that SHM is advocating for Medicare to include in the APM framework.

What’s Next?

Much remains to be solidified regarding implementation of MACRA, despite the fact it goes live in a few short years (see Figure 1). CMS has asked for comments and stakeholder input regarding MIPS and APMs, and it will be releasing the first round of rules around MACRA this year.

SHM is actively working with CMS to ensure this legislation will reflect the work we are doing as hospitalists to provide high-quality clinical care for our patients and enhance the performance of our hospitals and health system. TH

---

Dr. Doctoroff is a hospitalist at Beth Israel Deaconess Medical Center and an instructor of medicine at Harvard Medical School in Boston. Dr. Dutta is a hospitalist at Rush University Medical Center and an assistant professor of medicine at Rush Medical College in Chicago. Both are members of the SHM Public Policy Committee.

Last year, Congress passed legislation to permanently eliminate the Sustainable Growth Rate (SGR) formula, created in 1997 and designed to hold Medicare Part B or outpatient spending under control. Allowing the SGR to go into effect would have severely cut physician reimbursements in recent years, but Congress passed legislation each year to temporarily avert these cuts (also known annually as the “doc fix”). In search of a permanent solution, the passage of bipartisan legislation permanently repealing the SGR in 2015 was hailed as a way to ensure more certainty around the future of Medicare payments for physicians.

This legislation (H.R. 2, 114th Congress), sponsored by Rep. Michael C. Burgess (R-Texas) and entitled “Medicare Access and CHIP Reauthorization Act of 2015,” or MACRA, does much more than simply remove the SGR’s threat of broader Medicare payment cuts. The law changes the ways physicians are reimbursed by Medicare and continues to shift our healthcare system away from volume-based reimbursements and toward a value-based payment system.

What Is MIPS?

MACRA creates two value-based payment tracks for physicians. The first, the Merit-Based Incentive Payment System (MIPS), is closer to the old fee-for-service model of reimbursement. However, MIPS takes into account both volume and quality (i.e., payment is adjusted based on physician-quality scores). These physician-specific scores broaden the scope of quality measurement by including new measures related to resource utilization, electronic health record (EHR) use, and clinical improvement practices, along with the traditional clinical quality markers.

Under MIPS, the current Physician Quality Reporting System (PQRS), EHR Incentive Program, and Physician Value-Based Modifier all will be integrated into this single-payment adjustment.

The range of potential payment adjustments based on a physician’s MIPS score grows each year through 2022 (in 2022, adjustments can range from +9% to -9%). The program is budget neutral, which means that increases in payments to high-scoring providers will be offset by decreases in payments to low-scoring providers. For 2019 to 2024, there also will be an additional payment adjustment given to the highest MIPS performers for exceptional performance.

A benefit of MIPS is that it will streamline the various quality-reporting programs currently in place into one single program and does not ask physicians to assume any additional financial risk related to outcomes when taking care of patients. However, the particulars of how the MIPS score will be calculated are yet to be determined, and much of the utility and palatability of this score will depend on the chosen metrics. The goal of these metrics should be that they are meaningful, valid, and attributable to specific providers.

What Are APMs?

The other payment option MACRA provides for physicians allows them to opt out of MIPS and participate in the Alternative Payment Models (APMs) track. To incentivize physicians to take part in this riskier track, providers taking part in APMs will receive some extra money for their participation: a 5% annual lump sum bonus on reimbursement payments. To clarify, qualifying APMs are those where providers take on “more than nominal” financial risk, report on their quality measures, and use certified EHR technology.

To qualify as a participant in an APM (for example, the Medicare Shared Savings Program), providers must hit a threshold for percentage of total revenue received or percentage of patients from qualifying APMs. This threshold will increase over time. For example, from 2019 to 2020, providers must obtain at least 25% of their Medicare revenue or patients via APMs, whereas in 2023, 75% of their Medicare revenue or \ patients will need to come from APMs.

Providers will benefit from the increased reimbursement offered if they participate in APMs. There also is funding allocated in MACRA to help develop quality measures, with a call for physician leads to develop quality standards. This payment model, however, does come with increased financial risk for the provider contingent on patient outcomes. In addition, it may be difficult for all providers to hit the thresholds for participation.

 

Stick with MIPS? Or Take the Plunge with APM?

How MACRA affects you will depend a lot on the practice environment. As described above, MACRA is designed to move physicians into risk-based payment structures if possible. If possible, or otherwise, to simplify the current fee-for-service mechanism of payment by consolidating various Medicare pay-for-performance programs.

Let’s look at a few scenarios:

Hospitalist A works for a physician group that assumes risk for patients in a MACRA-approved APM and sees only those inpatients as opposed to unassigned patients. Therefore, almost all of hospitalist A’s patients are covered by risk-based contracts, and hospitalist A might be well positioned for the new APM structure.

Hospitalist B works for a group, or a university, and sees whatever patients are admitted to the hospital. Hospitalist B’s eligibility to participate in the APM will depend on the percentage of patients in alternative payment models in their market. If hospitalist B’s market has many Medicare accountable care organizations, and Medicaid and the commercial insurers compensate through a risk-sharing model, hospitalist B might reach the threshold. This is more accidental than planned, however, and hospitalist B might not be able to consistently hit this threshold year after year.

In addition, just working within the model will probably not be enough to qualify. Hospitalist B will need to also take on “more than nominal risk” as a participant in the model. In an employed academic setting, where the hospital is taking on risk as part of an APM, it is unlikely hospitalist B will qualify just by virtue of hospital employment. Hospitalist B must also meet/exceed the patient or payment thresholds under the model.

Bottom line: Given the current situation, we expect many hospitalists will likely be required to participate in MIPS and not qualify for APMs. Understanding the details and expectations now will help them be successful in the future.

Is MACRA Good for Hospitalists?

Most of organized medicine is happy to be free from the annual threat of reimbursement cuts. In addition, the new law might streamline quality reporting. But the specific upside depends on your perspective.

With APMs, a hospitalist might enjoy more upside potential, particularly for high-quality work and EHR use. However, whether it is realistic for most hospitalists to even participate in the model depends on many factors, as described previously, and SHM is advocating for the law to be implemented in ways that will more readily accommodate hospitalist practice and employment structures.

For example, the SHM Public Policy Committee has provided the Centers for Medicare & Medicaid Services (CMS) with realistic options for implementing the APM framework that would allow hospitalist B in the above example to qualify as an APM participant.

With MIPS, the benefit to hospitalists depends a fair amount on the way the law is implemented: how quality reporting happens, what metrics will count as quality improvement efforts, and how utilization of EHRs is measured.

What Issues Should Hospitalists Be Aware Of?

As MACRA is further developed, the main issue for hospitalists will be to ensure fairness in assessing quality and incentive payments. As previously encountered with quality reporting, hospitalists are not differentiated clearly from outpatient providers. As a result, they could suffer from the comparison of their quality outcomes for their sicker hospitalized patients to the patients cared for in a typical primary-care internal medicine practice. This inaccurate comparison poses problems in both models.

A potential solution would be a hospitalist-specific billing code, which would make it easier to identify hospitalists. SHM applied for and advocated for the approval of such a billing code and the request was recently approved by CMS.

 

In addition, as hospitalists mostly work in groups with shift-based schedules, thus sharing care of patients, individual identifiers may not be as significant as possibly looking at hospital, system, or team-based metrics. Using facility performance measures for both clinical quality and performance improvement—where hospitalists can opt to align with their hospital, which is already reporting quality outcomes—might be one way out of this conundrum. It would take into account the type of facility-level quality improvement work many hospitalists participate in. This also would decrease reporting burden for hospitalist groups.

SHM has advocated for this solution and was able to ensure this concept was included in the law; however, it is unclear when or how CMS will implement it.

To summarize, looking good in quality reporting will continue to be a challenge for hospitalists. It will be critical to keep pressure on CMS to implement solutions that account for the unique situation of our specialty.

Another issue to be aware of is the ability of hospitalists to participate in APMs. As with other facility-based providers, hospitalists have little control over whether their facility participates in an APM. Ways to ensure hospitalists can reach thresholds for participation could include allowing the various APMs that hospitalist patients are aligned with count toward an individual hospitalists’ APM participation total—a solution that SHM is advocating for Medicare to include in the APM framework.

What’s Next?

Much remains to be solidified regarding implementation of MACRA, despite the fact it goes live in a few short years (see Figure 1). CMS has asked for comments and stakeholder input regarding MIPS and APMs, and it will be releasing the first round of rules around MACRA this year.

SHM is actively working with CMS to ensure this legislation will reflect the work we are doing as hospitalists to provide high-quality clinical care for our patients and enhance the performance of our hospitals and health system. TH

---

Dr. Doctoroff is a hospitalist at Beth Israel Deaconess Medical Center and an instructor of medicine at Harvard Medical School in Boston. Dr. Dutta is a hospitalist at Rush University Medical Center and an assistant professor of medicine at Rush Medical College in Chicago. Both are members of the SHM Public Policy Committee.

When developing the “Fight the Resistance” campaign last year, the SHM team knew that antibiotic resistance would continue to be one of the most high-profile medical concerns heading into 2016. To promote appropriate antibiotic prescribing, SHM worked with its members to establish the following recommendations for clinicians and other hospital-based staff to promote awareness and inspire a dialogue around antibiotic stewardship:

• Identify opportunities to engage with all hospital-based clinicians to improve antibiotic stewardship in your hospital.
• Pay attention to appropriate antibiotic choice and resistance patterns and identify mechanisms to educate providers on overprescribing in your hospital.
• Consider the following:

  Adhere to antibiotic treatment guidelines.

  Track the day.

  Set a stop date.

  Reevaluate therapy.

  Streamline therapy.

  Avoid automatic time courses.

As part of this initiative, SHM designed a series of posters inspired by the propaganda style of the early 20th century to display the recommendations and asked for your help to join the fight through SHM’s first Twitter contest. The support and enthusiasm from members and nonmembers alike were contagious! To enter, participants took a photo of themselves and their teams hanging a “Fight the Resistance” poster in their hospitals or offices, then tweeted the photo with the #FightTheResistance hashtag to @SHMLive.

Not only did participants receive recognition for their efforts hanging up the posters and engaging their teams, the posters’ presence in various hospitals and offices around the country created thousands of impressions among hospital-based staff and others directly responsible for proper antibiotic prescribing.

Although the contest is over, you can still help facilitate culture change related to appropriate antibiotic prescribing. Follow SHM on Twitter @SHMLive, and continue to visit FightTheResistance.org for the latest updates on the campaign and new tools to promote antibiotic stewardship. TH

---

Brett Radler is SHM’s communications coordinator.

When developing the “Fight the Resistance” campaign last year, the SHM team knew that antibiotic resistance would continue to be one of the most high-profile medical concerns heading into 2016. To promote appropriate antibiotic prescribing, SHM worked with its members to establish the following recommendations for clinicians and other hospital-based staff to promote awareness and inspire a dialogue around antibiotic stewardship:

• Identify opportunities to engage with all hospital-based clinicians to improve antibiotic stewardship in your hospital.
• Pay attention to appropriate antibiotic choice and resistance patterns and identify mechanisms to educate providers on overprescribing in your hospital.
• Consider the following:

  Adhere to antibiotic treatment guidelines.

  Track the day.

  Set a stop date.

  Reevaluate therapy.

  Streamline therapy.

  Avoid automatic time courses.

As part of this initiative, SHM designed a series of posters inspired by the propaganda style of the early 20th century to display the recommendations and asked for your help to join the fight through SHM’s first Twitter contest. The support and enthusiasm from members and nonmembers alike were contagious! To enter, participants took a photo of themselves and their teams hanging a “Fight the Resistance” poster in their hospitals or offices, then tweeted the photo with the #FightTheResistance hashtag to @SHMLive.

Not only did participants receive recognition for their efforts hanging up the posters and engaging their teams, the posters’ presence in various hospitals and offices around the country created thousands of impressions among hospital-based staff and others directly responsible for proper antibiotic prescribing.

Although the contest is over, you can still help facilitate culture change related to appropriate antibiotic prescribing. Follow SHM on Twitter @SHMLive, and continue to visit FightTheResistance.org for the latest updates on the campaign and new tools to promote antibiotic stewardship. TH

---

Brett Radler is SHM’s communications coordinator.

When developing the “Fight the Resistance” campaign last year, the SHM team knew that antibiotic resistance would continue to be one of the most high-profile medical concerns heading into 2016. To promote appropriate antibiotic prescribing, SHM worked with its members to establish the following recommendations for clinicians and other hospital-based staff to promote awareness and inspire a dialogue around antibiotic stewardship:

• Identify opportunities to engage with all hospital-based clinicians to improve antibiotic stewardship in your hospital.
• Pay attention to appropriate antibiotic choice and resistance patterns and identify mechanisms to educate providers on overprescribing in your hospital.
• Consider the following:

  Adhere to antibiotic treatment guidelines.

  Track the day.

  Set a stop date.

  Reevaluate therapy.

  Streamline therapy.

  Avoid automatic time courses.

As part of this initiative, SHM designed a series of posters inspired by the propaganda style of the early 20th century to display the recommendations and asked for your help to join the fight through SHM’s first Twitter contest. The support and enthusiasm from members and nonmembers alike were contagious! To enter, participants took a photo of themselves and their teams hanging a “Fight the Resistance” poster in their hospitals or offices, then tweeted the photo with the #FightTheResistance hashtag to @SHMLive.

Not only did participants receive recognition for their efforts hanging up the posters and engaging their teams, the posters’ presence in various hospitals and offices around the country created thousands of impressions among hospital-based staff and others directly responsible for proper antibiotic prescribing.

Although the contest is over, you can still help facilitate culture change related to appropriate antibiotic prescribing. Follow SHM on Twitter @SHMLive, and continue to visit FightTheResistance.org for the latest updates on the campaign and new tools to promote antibiotic stewardship. TH

---

Brett Radler is SHM’s communications coordinator.

New research indicates that gut microbes alter platelet function, which affects the risk of thrombosis and related events like heart attack and stroke.

When the nutrient choline, which is abundant in animal products like meat and egg yolk, is ingested, gut microbes play a role in breaking it down and producing the compound TMAO.

Recent studies have shown that blood TMAO levels are associated with a heightened risk of heart attack and stroke.

The new study, published in Cell, suggests that TMAO encourages hyper-reactive platelet function, thereby increasing the likelihood of thrombosis.

Researchers said this could be the mechanism by which TMAO increases the risk of heart attack and stroke. And these findings reveal a previously unrecognized mechanistic link between specific dietary nutrients, gut microbes, platelet function, and thrombosis risk.

“It is remarkable that gut microbes produce a compound that alters platelet function and thrombotic heart attack and stroke risk,” said study author Stanley Hazen, MD, PhD, of the Cleveland Clinic in Ohio.

“This new link helps explain how diet-induced TMAO generation is mechanistically linked to development of lethal adverse complications of heart disease.”

Dr Hazen and his colleagues first discovered a link between TMAO, gut microbes, and heart disease 5 years ago.

For the current study, the researchers analyzed blood levels of TMAO in more than 4000 patients and saw a significant correlation between higher TMAO and thrombosis potential. This led to the hypothesis that TMAO may directly impact platelet function.

Subsequent studies with both human platelets and animal models confirmed that TMAO makes platelets hyper-reactive, heightening thrombosis potential and accelerating clotting rates.

“We have shown that TMAO fundamentally alters calcium signaling within platelets,” Dr Hazen said. “When TMAO is elevated, platelet responsiveness to known triggers like thrombin, collagen, or ADP is heightened.”

“In general, there’s a broad range for how quickly different people will form clots. However, across the board, when TMAO is elevated, platelet responsiveness jumps to the hyper-reactive side of normal.”

Dr Hazen and his colleagues said these results suggest that lowering TMAO—via dietary manipulation, alteration in microbial community with a probiotic or prebiotic, or direct pharmacological inhibition of microbial enzymes involved in TMA production—may be a way to reduce the risk of thrombotic events.

They noted that, unlike current antiplatelet therapies, targeting TMAO would likely reduce platelet hyper-responsiveness to the normal range and not induce impairment in overall platelet function. So the intervention could attenuate pro-thrombotic tendencies without increasing the risk of bleeding complications.

New research indicates that gut microbes alter platelet function, which affects the risk of thrombosis and related events like heart attack and stroke.

When the nutrient choline, which is abundant in animal products like meat and egg yolk, is ingested, gut microbes play a role in breaking it down and producing the compound TMAO.

Recent studies have shown that blood TMAO levels are associated with a heightened risk of heart attack and stroke.

The new study, published in Cell, suggests that TMAO encourages hyper-reactive platelet function, thereby increasing the likelihood of thrombosis.

Researchers said this could be the mechanism by which TMAO increases the risk of heart attack and stroke. And these findings reveal a previously unrecognized mechanistic link between specific dietary nutrients, gut microbes, platelet function, and thrombosis risk.

“It is remarkable that gut microbes produce a compound that alters platelet function and thrombotic heart attack and stroke risk,” said study author Stanley Hazen, MD, PhD, of the Cleveland Clinic in Ohio.

“This new link helps explain how diet-induced TMAO generation is mechanistically linked to development of lethal adverse complications of heart disease.”

Dr Hazen and his colleagues first discovered a link between TMAO, gut microbes, and heart disease 5 years ago.

For the current study, the researchers analyzed blood levels of TMAO in more than 4000 patients and saw a significant correlation between higher TMAO and thrombosis potential. This led to the hypothesis that TMAO may directly impact platelet function.

Subsequent studies with both human platelets and animal models confirmed that TMAO makes platelets hyper-reactive, heightening thrombosis potential and accelerating clotting rates.

“We have shown that TMAO fundamentally alters calcium signaling within platelets,” Dr Hazen said. “When TMAO is elevated, platelet responsiveness to known triggers like thrombin, collagen, or ADP is heightened.”

“In general, there’s a broad range for how quickly different people will form clots. However, across the board, when TMAO is elevated, platelet responsiveness jumps to the hyper-reactive side of normal.”

Dr Hazen and his colleagues said these results suggest that lowering TMAO—via dietary manipulation, alteration in microbial community with a probiotic or prebiotic, or direct pharmacological inhibition of microbial enzymes involved in TMA production—may be a way to reduce the risk of thrombotic events.

They noted that, unlike current antiplatelet therapies, targeting TMAO would likely reduce platelet hyper-responsiveness to the normal range and not induce impairment in overall platelet function. So the intervention could attenuate pro-thrombotic tendencies without increasing the risk of bleeding complications.

New research indicates that gut microbes alter platelet function, which affects the risk of thrombosis and related events like heart attack and stroke.

When the nutrient choline, which is abundant in animal products like meat and egg yolk, is ingested, gut microbes play a role in breaking it down and producing the compound TMAO.

Recent studies have shown that blood TMAO levels are associated with a heightened risk of heart attack and stroke.

The new study, published in Cell, suggests that TMAO encourages hyper-reactive platelet function, thereby increasing the likelihood of thrombosis.

Researchers said this could be the mechanism by which TMAO increases the risk of heart attack and stroke. And these findings reveal a previously unrecognized mechanistic link between specific dietary nutrients, gut microbes, platelet function, and thrombosis risk.

“It is remarkable that gut microbes produce a compound that alters platelet function and thrombotic heart attack and stroke risk,” said study author Stanley Hazen, MD, PhD, of the Cleveland Clinic in Ohio.

“This new link helps explain how diet-induced TMAO generation is mechanistically linked to development of lethal adverse complications of heart disease.”

Dr Hazen and his colleagues first discovered a link between TMAO, gut microbes, and heart disease 5 years ago.

For the current study, the researchers analyzed blood levels of TMAO in more than 4000 patients and saw a significant correlation between higher TMAO and thrombosis potential. This led to the hypothesis that TMAO may directly impact platelet function.

Subsequent studies with both human platelets and animal models confirmed that TMAO makes platelets hyper-reactive, heightening thrombosis potential and accelerating clotting rates.

“We have shown that TMAO fundamentally alters calcium signaling within platelets,” Dr Hazen said. “When TMAO is elevated, platelet responsiveness to known triggers like thrombin, collagen, or ADP is heightened.”

“In general, there’s a broad range for how quickly different people will form clots. However, across the board, when TMAO is elevated, platelet responsiveness jumps to the hyper-reactive side of normal.”

Dr Hazen and his colleagues said these results suggest that lowering TMAO—via dietary manipulation, alteration in microbial community with a probiotic or prebiotic, or direct pharmacological inhibition of microbial enzymes involved in TMA production—may be a way to reduce the risk of thrombotic events.

They noted that, unlike current antiplatelet therapies, targeting TMAO would likely reduce platelet hyper-responsiveness to the normal range and not induce impairment in overall platelet function. So the intervention could attenuate pro-thrombotic tendencies without increasing the risk of bleeding complications.

Cancer trials with negative results don’t make an immediate splash in the scientific literature, but they do have a long-term impact on research, according to a study published in JAMA Oncology.

Researchers found that first reports of positive phase 3 cancer trials were twice as likely as first reports of negative phase 3 cancer trials

to be cited in scientific journals.

But over time, when all articles associated with the trials were considered, the scientific impact of negative trials and positive trials was about the same.

“Negative trials aren’t scientific failures,” said study author Joseph Unger, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

“We found that they have a positive, lasting impact on cancer research.”

Dr Unger and his colleagues analyzed every randomized, phase 3 cancer trial completed by the cooperative group SWOG from 1984 to 2014. This amounted to 94 studies involving 46,424 patients.

Of those 94 studies, 26 were positive, meaning that the treatment tested performed measurably better than the standard treatment at the time.

Analyses revealed that primary manuscripts first announcing these encouraging results were published in journals with higher impact factors and were cited twice as often as primary manuscripts of negative trials.

The mean 2-year impact factor of the journals was 28 for positive trials and 18 for negative trials (P=0.007). And the mean number of citations per year was 43 for positive trials and 21 for negative trials (P=0.03).

However, when the researchers looked at the number of citations from all primary and secondary manuscripts, they did not see a significant difference between positive and negative trials. The mean number of citations per year was 55 and 45, respectively (P=0.53).

“Negative trials matter because they tell us what doesn’t work, which can be as important as what does,” said study author Dawn Hershman, MD, of Columbia University Medical Center in New York, New York.

“Negative trials are also critical for secondary research, which mines existing trial data to answer new questions in cancer care and prevention. Negative trials are used frequently in secondary research and add great value to the scientific community.”

Cancer trials with negative results don’t make an immediate splash in the scientific literature, but they do have a long-term impact on research, according to a study published in JAMA Oncology.

Researchers found that first reports of positive phase 3 cancer trials were twice as likely as first reports of negative phase 3 cancer trials

to be cited in scientific journals.

But over time, when all articles associated with the trials were considered, the scientific impact of negative trials and positive trials was about the same.

“Negative trials aren’t scientific failures,” said study author Joseph Unger, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

“We found that they have a positive, lasting impact on cancer research.”

Dr Unger and his colleagues analyzed every randomized, phase 3 cancer trial completed by the cooperative group SWOG from 1984 to 2014. This amounted to 94 studies involving 46,424 patients.

Of those 94 studies, 26 were positive, meaning that the treatment tested performed measurably better than the standard treatment at the time.

Analyses revealed that primary manuscripts first announcing these encouraging results were published in journals with higher impact factors and were cited twice as often as primary manuscripts of negative trials.

The mean 2-year impact factor of the journals was 28 for positive trials and 18 for negative trials (P=0.007). And the mean number of citations per year was 43 for positive trials and 21 for negative trials (P=0.03).

However, when the researchers looked at the number of citations from all primary and secondary manuscripts, they did not see a significant difference between positive and negative trials. The mean number of citations per year was 55 and 45, respectively (P=0.53).

“Negative trials matter because they tell us what doesn’t work, which can be as important as what does,” said study author Dawn Hershman, MD, of Columbia University Medical Center in New York, New York.

“Negative trials are also critical for secondary research, which mines existing trial data to answer new questions in cancer care and prevention. Negative trials are used frequently in secondary research and add great value to the scientific community.”

Cancer trials with negative results don’t make an immediate splash in the scientific literature, but they do have a long-term impact on research, according to a study published in JAMA Oncology.

Researchers found that first reports of positive phase 3 cancer trials were twice as likely as first reports of negative phase 3 cancer trials

to be cited in scientific journals.

But over time, when all articles associated with the trials were considered, the scientific impact of negative trials and positive trials was about the same.

“Negative trials aren’t scientific failures,” said study author Joseph Unger, PhD, of the Fred Hutchinson Cancer Research Center in Seattle, Washington.

“We found that they have a positive, lasting impact on cancer research.”

Dr Unger and his colleagues analyzed every randomized, phase 3 cancer trial completed by the cooperative group SWOG from 1984 to 2014. This amounted to 94 studies involving 46,424 patients.

Of those 94 studies, 26 were positive, meaning that the treatment tested performed measurably better than the standard treatment at the time.

Analyses revealed that primary manuscripts first announcing these encouraging results were published in journals with higher impact factors and were cited twice as often as primary manuscripts of negative trials.

The mean 2-year impact factor of the journals was 28 for positive trials and 18 for negative trials (P=0.007). And the mean number of citations per year was 43 for positive trials and 21 for negative trials (P=0.03).

However, when the researchers looked at the number of citations from all primary and secondary manuscripts, they did not see a significant difference between positive and negative trials. The mean number of citations per year was 55 and 45, respectively (P=0.53).

“Negative trials matter because they tell us what doesn’t work, which can be as important as what does,” said study author Dawn Hershman, MD, of Columbia University Medical Center in New York, New York.

“Negative trials are also critical for secondary research, which mines existing trial data to answer new questions in cancer care and prevention. Negative trials are used frequently in secondary research and add great value to the scientific community.”

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

jancin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

jancin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.

“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”

jancin

Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.

The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.

The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.

Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).

The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.

Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.

Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.

CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.

[email protected]

On Twitter @whitneymcknight

MONTREAL – Patients who stayed on antiplatelet therapy close to – or even up until – major surgery fared just as well as those who stopped their medication earlier in a retrospective, single-center study.

The study found no difference in blood product administration, adverse perioperative events, or all-cause 30-day mortality regardless of whether patients stopped clopidogrel (Plavix) the recommended 5 days before surgery.

“We believe that continuing clopidogrel in elective and emergent surgical situations appears to be safe, and may challenge the current recommendations,” said presenter Dr. David Strosberg.

Kari Oakes/Frontline Medical News

The study addressed a thorny question for surgeons, Dr. Strosberg said. “As surgeons, we face a dilemma: Do we take the risk of thrombotic complications in stopping the antiplatelet drugs, or do we take the risk of increased surgical bleeding with continuing therapy?”

The package insert for clopidogrel advises discontinuation 5 days prior to surgery. However, manufacturer labeling also states that discontinuation of clopidogrel can lead to adverse cardiac events, said Dr. Strosberg, a general surgery resident at Ohio State University in Columbus.

The aim of the study, presented at the annual meeting of the Central Surgical Association, was to ascertain whether continuing antiplatelet therapy increased the rate of adverse surgical outcomes in those undergoing major emergent or elective surgery.

Dr. Strosberg and his colleagues retrospectively reviewed the record of patients over a 4-year period at a single institution and included those undergoing major general, thoracic, or vascular surgery who were taking clopidogrel at the time of presentation.

Data collected included patient characteristics, including demographic data and comorbidities, as well as transfusion requirements and perioperative events.

A total of 200 patients who had 205 qualifying procedures and were taking clopidogrel were included in the study. Of these, 116 patients (Group A) had their clopidogrel held for at least 5 days preoperatively. The remaining 89 patients (Group B) had their clopidogrel held for less than 5 days, or not at all.

Patient demographics were similar between the two groups. Patients in Group A were more likely to have emergency surgery, to have peripheral stents placed, to have COPD or peripheral vascular disease, to have a malignancy, and to have received aspirin within five days of surgery (P less than .01 for all).

Blood product administration rates and volumes did not differ significantly between the two groups, and there was no difference between the groups in the incidence of myocardial infarctions, cerebrovascular events, or acute visceral or lower extremity ischemia.

Three patients in each group died within 30 days of the procedure, a nonsignificant difference. However, in the group that had clopidogrel held, three patients had perioperative myocardial infarctions, and two of these patients died. In discussing the study, Dr. Michael Dalsing said, “I think a lot of us would accept bleeding more over myocardial infarction.”

A subgroup analysis of the group who had clopidogrel held for fewer than 5 days compared outcomes for emergent vs. non-emergent surgery. The emergent surgery subgroup had a significantly higher rate of preoperative platelet transfusions, although numbers overall were small (2/17, 11.8%, vs. 0/72; P = .03).

Dr. Strosberg noted study limitations that included the retrospective, single-center nature of the study, and the fact that one variable, estimated blood loss, is notoriously subjective and inaccurate.

Dr. Dalsing, chief of vascular surgery at Indiana University, Indianapolis, said that he “was surprised that not even one patient went back for postoperative bleeding in this high-risk group of patients,” and raised the question of potential selection bias. Dr. Strosberg replied that comorbidities were ascertained by the physician at the time of surgery planning; since no differences were seen between study groups, investigators didn’t go back and parse out details about comorbid conditions.

In discussion following the presentation, surgeons spoke to the real-world challenges of performing surgery on a patient with antiplatelet therapy on board.

“Overall, I think your data support kind of a bias I have. Since I’m a vascular surgeon, we almost always operate on clopidogrel, and I don’t know if our bleeding risk is worse or better. But it’s something we almost have to do to keep our grafts going,” Dr. Dalsing said.

Dr. Peter Henke, professor of vascular surgery at the University of Michigan, Ann Arbor, said, “I’d be a little bit cautious with this. If you’ve ever done a big aortic procedure on someone on Plavix, I’ve seen them lose up to a couple of liters of blood just with oozing.”

“Those of us who do open aortic surgery know that very few things bleed like the back wall of an aortic anastomosis of a patient on Plavix,” echoed Dr. Peter Rossi, associate professor of vascular surgery at the Medical College of Wisconsin, Milwaukee.

 

The study authors reported no relevant disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – Patients who stayed on antiplatelet therapy close to – or even up until – major surgery fared just as well as those who stopped their medication earlier in a retrospective, single-center study.

The study found no difference in blood product administration, adverse perioperative events, or all-cause 30-day mortality regardless of whether patients stopped clopidogrel (Plavix) the recommended 5 days before surgery.

“We believe that continuing clopidogrel in elective and emergent surgical situations appears to be safe, and may challenge the current recommendations,” said presenter Dr. David Strosberg.

Kari Oakes/Frontline Medical News

The study addressed a thorny question for surgeons, Dr. Strosberg said. “As surgeons, we face a dilemma: Do we take the risk of thrombotic complications in stopping the antiplatelet drugs, or do we take the risk of increased surgical bleeding with continuing therapy?”

The package insert for clopidogrel advises discontinuation 5 days prior to surgery. However, manufacturer labeling also states that discontinuation of clopidogrel can lead to adverse cardiac events, said Dr. Strosberg, a general surgery resident at Ohio State University in Columbus.

The aim of the study, presented at the annual meeting of the Central Surgical Association, was to ascertain whether continuing antiplatelet therapy increased the rate of adverse surgical outcomes in those undergoing major emergent or elective surgery.

Dr. Strosberg and his colleagues retrospectively reviewed the record of patients over a 4-year period at a single institution and included those undergoing major general, thoracic, or vascular surgery who were taking clopidogrel at the time of presentation.

Data collected included patient characteristics, including demographic data and comorbidities, as well as transfusion requirements and perioperative events.

A total of 200 patients who had 205 qualifying procedures and were taking clopidogrel were included in the study. Of these, 116 patients (Group A) had their clopidogrel held for at least 5 days preoperatively. The remaining 89 patients (Group B) had their clopidogrel held for less than 5 days, or not at all.

Patient demographics were similar between the two groups. Patients in Group A were more likely to have emergency surgery, to have peripheral stents placed, to have COPD or peripheral vascular disease, to have a malignancy, and to have received aspirin within five days of surgery (P less than .01 for all).

Blood product administration rates and volumes did not differ significantly between the two groups, and there was no difference between the groups in the incidence of myocardial infarctions, cerebrovascular events, or acute visceral or lower extremity ischemia.

Three patients in each group died within 30 days of the procedure, a nonsignificant difference. However, in the group that had clopidogrel held, three patients had perioperative myocardial infarctions, and two of these patients died. In discussing the study, Dr. Michael Dalsing said, “I think a lot of us would accept bleeding more over myocardial infarction.”

A subgroup analysis of the group who had clopidogrel held for fewer than 5 days compared outcomes for emergent vs. non-emergent surgery. The emergent surgery subgroup had a significantly higher rate of preoperative platelet transfusions, although numbers overall were small (2/17, 11.8%, vs. 0/72; P = .03).

Dr. Strosberg noted study limitations that included the retrospective, single-center nature of the study, and the fact that one variable, estimated blood loss, is notoriously subjective and inaccurate.

Dr. Dalsing, chief of vascular surgery at Indiana University, Indianapolis, said that he “was surprised that not even one patient went back for postoperative bleeding in this high-risk group of patients,” and raised the question of potential selection bias. Dr. Strosberg replied that comorbidities were ascertained by the physician at the time of surgery planning; since no differences were seen between study groups, investigators didn’t go back and parse out details about comorbid conditions.

In discussion following the presentation, surgeons spoke to the real-world challenges of performing surgery on a patient with antiplatelet therapy on board.

“Overall, I think your data support kind of a bias I have. Since I’m a vascular surgeon, we almost always operate on clopidogrel, and I don’t know if our bleeding risk is worse or better. But it’s something we almost have to do to keep our grafts going,” Dr. Dalsing said.

Dr. Peter Henke, professor of vascular surgery at the University of Michigan, Ann Arbor, said, “I’d be a little bit cautious with this. If you’ve ever done a big aortic procedure on someone on Plavix, I’ve seen them lose up to a couple of liters of blood just with oozing.”

“Those of us who do open aortic surgery know that very few things bleed like the back wall of an aortic anastomosis of a patient on Plavix,” echoed Dr. Peter Rossi, associate professor of vascular surgery at the Medical College of Wisconsin, Milwaukee.

 

The study authors reported no relevant disclosures.

[email protected]

On Twitter @karioakes

MONTREAL – Patients who stayed on antiplatelet therapy close to – or even up until – major surgery fared just as well as those who stopped their medication earlier in a retrospective, single-center study.

The study found no difference in blood product administration, adverse perioperative events, or all-cause 30-day mortality regardless of whether patients stopped clopidogrel (Plavix) the recommended 5 days before surgery.

“We believe that continuing clopidogrel in elective and emergent surgical situations appears to be safe, and may challenge the current recommendations,” said presenter Dr. David Strosberg.

Kari Oakes/Frontline Medical News

The study addressed a thorny question for surgeons, Dr. Strosberg said. “As surgeons, we face a dilemma: Do we take the risk of thrombotic complications in stopping the antiplatelet drugs, or do we take the risk of increased surgical bleeding with continuing therapy?”

The package insert for clopidogrel advises discontinuation 5 days prior to surgery. However, manufacturer labeling also states that discontinuation of clopidogrel can lead to adverse cardiac events, said Dr. Strosberg, a general surgery resident at Ohio State University in Columbus.

The aim of the study, presented at the annual meeting of the Central Surgical Association, was to ascertain whether continuing antiplatelet therapy increased the rate of adverse surgical outcomes in those undergoing major emergent or elective surgery.

Dr. Strosberg and his colleagues retrospectively reviewed the record of patients over a 4-year period at a single institution and included those undergoing major general, thoracic, or vascular surgery who were taking clopidogrel at the time of presentation.

Data collected included patient characteristics, including demographic data and comorbidities, as well as transfusion requirements and perioperative events.

A total of 200 patients who had 205 qualifying procedures and were taking clopidogrel were included in the study. Of these, 116 patients (Group A) had their clopidogrel held for at least 5 days preoperatively. The remaining 89 patients (Group B) had their clopidogrel held for less than 5 days, or not at all.

Patient demographics were similar between the two groups. Patients in Group A were more likely to have emergency surgery, to have peripheral stents placed, to have COPD or peripheral vascular disease, to have a malignancy, and to have received aspirin within five days of surgery (P less than .01 for all).

Blood product administration rates and volumes did not differ significantly between the two groups, and there was no difference between the groups in the incidence of myocardial infarctions, cerebrovascular events, or acute visceral or lower extremity ischemia.

Three patients in each group died within 30 days of the procedure, a nonsignificant difference. However, in the group that had clopidogrel held, three patients had perioperative myocardial infarctions, and two of these patients died. In discussing the study, Dr. Michael Dalsing said, “I think a lot of us would accept bleeding more over myocardial infarction.”

A subgroup analysis of the group who had clopidogrel held for fewer than 5 days compared outcomes for emergent vs. non-emergent surgery. The emergent surgery subgroup had a significantly higher rate of preoperative platelet transfusions, although numbers overall were small (2/17, 11.8%, vs. 0/72; P = .03).

Dr. Strosberg noted study limitations that included the retrospective, single-center nature of the study, and the fact that one variable, estimated blood loss, is notoriously subjective and inaccurate.

Dr. Dalsing, chief of vascular surgery at Indiana University, Indianapolis, said that he “was surprised that not even one patient went back for postoperative bleeding in this high-risk group of patients,” and raised the question of potential selection bias. Dr. Strosberg replied that comorbidities were ascertained by the physician at the time of surgery planning; since no differences were seen between study groups, investigators didn’t go back and parse out details about comorbid conditions.

In discussion following the presentation, surgeons spoke to the real-world challenges of performing surgery on a patient with antiplatelet therapy on board.

“Overall, I think your data support kind of a bias I have. Since I’m a vascular surgeon, we almost always operate on clopidogrel, and I don’t know if our bleeding risk is worse or better. But it’s something we almost have to do to keep our grafts going,” Dr. Dalsing said.

Dr. Peter Henke, professor of vascular surgery at the University of Michigan, Ann Arbor, said, “I’d be a little bit cautious with this. If you’ve ever done a big aortic procedure on someone on Plavix, I’ve seen them lose up to a couple of liters of blood just with oozing.”

“Those of us who do open aortic surgery know that very few things bleed like the back wall of an aortic anastomosis of a patient on Plavix,” echoed Dr. Peter Rossi, associate professor of vascular surgery at the Medical College of Wisconsin, Milwaukee.

 

The study authors reported no relevant disclosures.

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