The Food and Drug Administration approved the antioxidant drug edaravone on May 5 for the treatment of amyotrophic lateral sclerosis, making it only the second drug ever to be approved by the agency for the motor neuron disease.

The FDA granted approval for edaravone, to be marketed by Mitsubishi Tanabe Pharma America under the brand name Radicava, through its orphan drug pathway, which is meant for drugs used to treat rare diseases or conditions. The Centers for Disease Control and Prevention estimates that amyotrophic lateral sclerosis (ALS) affects 12,000-15,000 Americans.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

The Food and Drug Administration approved the antioxidant drug edaravone on May 5 for the treatment of amyotrophic lateral sclerosis, making it only the second drug ever to be approved by the agency for the motor neuron disease.

The FDA granted approval for edaravone, to be marketed by Mitsubishi Tanabe Pharma America under the brand name Radicava, through its orphan drug pathway, which is meant for drugs used to treat rare diseases or conditions. The Centers for Disease Control and Prevention estimates that amyotrophic lateral sclerosis (ALS) affects 12,000-15,000 Americans.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

The Food and Drug Administration approved the antioxidant drug edaravone on May 5 for the treatment of amyotrophic lateral sclerosis, making it only the second drug ever to be approved by the agency for the motor neuron disease.

The FDA granted approval for edaravone, to be marketed by Mitsubishi Tanabe Pharma America under the brand name Radicava, through its orphan drug pathway, which is meant for drugs used to treat rare diseases or conditions. The Centers for Disease Control and Prevention estimates that amyotrophic lateral sclerosis (ALS) affects 12,000-15,000 Americans.

Courtesy Wikimedia Commons/FitzColinGerald/Creative Commons License

[email protected]

Micrograph showing CLL

Long-term follow-up of a phase 1 study suggests the BTK inhibitor ONO/GS-4059 can stave off progression in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Roughly 60% of the patients studied were progression-free and still taking ONO/GS-4059 at last follow-up, with the longest time on treatment exceeding 3 years.

In addition, researchers said the extended follow-up revealed no new safety concerns, and the maximum tolerated dose of ONO/GS-4059 has not been reached.

Martin Dyer, DPhil, of the University of Leicester in the UK, and his colleagues reported these results in Blood.

The research was funded by Gilead Sciences, Inc., and ONO Pharmaceuticals helped with data analysis.

The study enrolled 90 patients with relapsed or refractory B-cell malignancies, 28 of whom had CLL. Dr Dyer and his colleagues reported follow-up results in CLL patients only.

The patients’ median number of prior treatments was 4 (range, 2-9), and 11 patients were refractory to their last line of therapy. None had received prior treatment with a BTK inhibitor.

The patients received ONO/GS-4059 at varying doses, from 20 mg once daily (QD) to 600 mg QD and a twice-daily (BID) regimen of 300 mg. Six patients were also taking anticoagulant therapy while on study.

Patients were allowed to continue treatment with ONO/GS-4059 if they responded to the drug or maintained stable disease.

Initially, 25 patients were evaluable for response, and 24 of them responded to ONO/GS-4059, for an overall response rate of 96%.

At last follow-up on June 8, 2016, 17 patients were still receiving ONO/GS-4059, and all had a very good partial response.

Dr Dyer said the responses have been similar to those seen with other irreversible BTK inhibitors. Most have involved rapid and almost complete resolution of lymph node masses and rapid improvement in hematological indexes.

“It is clear . . . that the major responses occur rapidly, within the first 3 months of drug, and that, thereafter, improvement occurs at a much slower rate,” Dr Dyer said. “It will be of interest, I think, to look at the remaining patients on study to assess whether responses deepen with time on drug.”

The duration of treatment for these patients ranged from 302 days to 1160 days at last follow-up. They were receiving ONO/GS-4059 at doses ranging from 40 mg QD to 600 mg QD or 300 mg BID, and no maximum tolerated dose had been identified.

Eleven patients (39.3%) discontinued ONO/GS-4059 due to death (n=3), disease progression (n=4), adverse events (AEs, n=3), and sponsor decision due to extended drug interruption (n=1). One of the patients included in the AE group also had concurrent disease progression.

The median progression-free survival was 38.5 months, and the median overall survival was 44.9 months. The median time on study was 32.5 months.

The most common treatment-emergent AEs were bruising (35.7%), neutropenia (35.7%), anemia (32.1%), nasopharyngitis (32.1%), fall (32.1%), cough (28.6%), arthralgia (28.6%), and basal cell carcinoma (28.6%).

The most common grade 3/4 AEs included neutropenia (25%), thrombocytopenia (14.3%), lower respiratory tract infection (14.3%), and anemia (10.7%).

“Our long-term follow-up shows maintained efficacy without toxicity,” Dr Dyer said. “This study is the first report of long-term follow-up of a selective BTK inhibitor, and it is excellent news for patients. We are now doing studies of ONO/GS-4059 in combination with other precision medicines to assess whether these results can be enhanced in patients with CLL and other B-cell malignancies.” 

Micrograph showing CLL

Long-term follow-up of a phase 1 study suggests the BTK inhibitor ONO/GS-4059 can stave off progression in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Roughly 60% of the patients studied were progression-free and still taking ONO/GS-4059 at last follow-up, with the longest time on treatment exceeding 3 years.

In addition, researchers said the extended follow-up revealed no new safety concerns, and the maximum tolerated dose of ONO/GS-4059 has not been reached.

Martin Dyer, DPhil, of the University of Leicester in the UK, and his colleagues reported these results in Blood.

The research was funded by Gilead Sciences, Inc., and ONO Pharmaceuticals helped with data analysis.

The study enrolled 90 patients with relapsed or refractory B-cell malignancies, 28 of whom had CLL. Dr Dyer and his colleagues reported follow-up results in CLL patients only.

The patients’ median number of prior treatments was 4 (range, 2-9), and 11 patients were refractory to their last line of therapy. None had received prior treatment with a BTK inhibitor.

The patients received ONO/GS-4059 at varying doses, from 20 mg once daily (QD) to 600 mg QD and a twice-daily (BID) regimen of 300 mg. Six patients were also taking anticoagulant therapy while on study.

Patients were allowed to continue treatment with ONO/GS-4059 if they responded to the drug or maintained stable disease.

Initially, 25 patients were evaluable for response, and 24 of them responded to ONO/GS-4059, for an overall response rate of 96%.

At last follow-up on June 8, 2016, 17 patients were still receiving ONO/GS-4059, and all had a very good partial response.

Dr Dyer said the responses have been similar to those seen with other irreversible BTK inhibitors. Most have involved rapid and almost complete resolution of lymph node masses and rapid improvement in hematological indexes.

“It is clear . . . that the major responses occur rapidly, within the first 3 months of drug, and that, thereafter, improvement occurs at a much slower rate,” Dr Dyer said. “It will be of interest, I think, to look at the remaining patients on study to assess whether responses deepen with time on drug.”

The duration of treatment for these patients ranged from 302 days to 1160 days at last follow-up. They were receiving ONO/GS-4059 at doses ranging from 40 mg QD to 600 mg QD or 300 mg BID, and no maximum tolerated dose had been identified.

Eleven patients (39.3%) discontinued ONO/GS-4059 due to death (n=3), disease progression (n=4), adverse events (AEs, n=3), and sponsor decision due to extended drug interruption (n=1). One of the patients included in the AE group also had concurrent disease progression.

The median progression-free survival was 38.5 months, and the median overall survival was 44.9 months. The median time on study was 32.5 months.

The most common treatment-emergent AEs were bruising (35.7%), neutropenia (35.7%), anemia (32.1%), nasopharyngitis (32.1%), fall (32.1%), cough (28.6%), arthralgia (28.6%), and basal cell carcinoma (28.6%).

The most common grade 3/4 AEs included neutropenia (25%), thrombocytopenia (14.3%), lower respiratory tract infection (14.3%), and anemia (10.7%).

“Our long-term follow-up shows maintained efficacy without toxicity,” Dr Dyer said. “This study is the first report of long-term follow-up of a selective BTK inhibitor, and it is excellent news for patients. We are now doing studies of ONO/GS-4059 in combination with other precision medicines to assess whether these results can be enhanced in patients with CLL and other B-cell malignancies.” 

Micrograph showing CLL

Long-term follow-up of a phase 1 study suggests the BTK inhibitor ONO/GS-4059 can stave off progression in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

Roughly 60% of the patients studied were progression-free and still taking ONO/GS-4059 at last follow-up, with the longest time on treatment exceeding 3 years.

In addition, researchers said the extended follow-up revealed no new safety concerns, and the maximum tolerated dose of ONO/GS-4059 has not been reached.

Martin Dyer, DPhil, of the University of Leicester in the UK, and his colleagues reported these results in Blood.

The research was funded by Gilead Sciences, Inc., and ONO Pharmaceuticals helped with data analysis.

The study enrolled 90 patients with relapsed or refractory B-cell malignancies, 28 of whom had CLL. Dr Dyer and his colleagues reported follow-up results in CLL patients only.

The patients’ median number of prior treatments was 4 (range, 2-9), and 11 patients were refractory to their last line of therapy. None had received prior treatment with a BTK inhibitor.

The patients received ONO/GS-4059 at varying doses, from 20 mg once daily (QD) to 600 mg QD and a twice-daily (BID) regimen of 300 mg. Six patients were also taking anticoagulant therapy while on study.

Patients were allowed to continue treatment with ONO/GS-4059 if they responded to the drug or maintained stable disease.

Initially, 25 patients were evaluable for response, and 24 of them responded to ONO/GS-4059, for an overall response rate of 96%.

At last follow-up on June 8, 2016, 17 patients were still receiving ONO/GS-4059, and all had a very good partial response.

Dr Dyer said the responses have been similar to those seen with other irreversible BTK inhibitors. Most have involved rapid and almost complete resolution of lymph node masses and rapid improvement in hematological indexes.

“It is clear . . . that the major responses occur rapidly, within the first 3 months of drug, and that, thereafter, improvement occurs at a much slower rate,” Dr Dyer said. “It will be of interest, I think, to look at the remaining patients on study to assess whether responses deepen with time on drug.”

The duration of treatment for these patients ranged from 302 days to 1160 days at last follow-up. They were receiving ONO/GS-4059 at doses ranging from 40 mg QD to 600 mg QD or 300 mg BID, and no maximum tolerated dose had been identified.

Eleven patients (39.3%) discontinued ONO/GS-4059 due to death (n=3), disease progression (n=4), adverse events (AEs, n=3), and sponsor decision due to extended drug interruption (n=1). One of the patients included in the AE group also had concurrent disease progression.

The median progression-free survival was 38.5 months, and the median overall survival was 44.9 months. The median time on study was 32.5 months.

The most common treatment-emergent AEs were bruising (35.7%), neutropenia (35.7%), anemia (32.1%), nasopharyngitis (32.1%), fall (32.1%), cough (28.6%), arthralgia (28.6%), and basal cell carcinoma (28.6%).

The most common grade 3/4 AEs included neutropenia (25%), thrombocytopenia (14.3%), lower respiratory tract infection (14.3%), and anemia (10.7%).

“Our long-term follow-up shows maintained efficacy without toxicity,” Dr Dyer said. “This study is the first report of long-term follow-up of a selective BTK inhibitor, and it is excellent news for patients. We are now doing studies of ONO/GS-4059 in combination with other precision medicines to assess whether these results can be enhanced in patients with CLL and other B-cell malignancies.” 

Robert Lowell knew civic valor. Sixteen times and more he had been down on his knees in madness, he said. Sixteen times and more he had gotten up. He had gone back to his work, entered back into life. He had faced down uncertainty and madness, had created new forms when pushed to stay with the old, had brought back imaginative order from chaos. It was a different kind of courage, this civic courage, and the rules of engagement were unclear. Lowell’s life, as his daughter observed, was a messy one, difficult for him and for those who knew him. But it was lived with iron, and often with grace. He kept always in the front of his mind what he thought he ought to be, even when he couldn’t be it; he believed in what his country could be, even if it wasn’t. He worked hard at his art.

–Kay Redfield Jamison, PhD, in “Robert Lowell, Setting the River on Fire: A Study of Genius, Mania, and Character” (New York: Alfred A. Knopf, 2017).

Lowell, who lived from 1917 to 1977, was a two-time Pulitzer Prize winner, deemed to be the greatest American poet of his time. He studied the classics and was obsessed with Napoleon as a child, and he drew on the work of other great poets and classicists as influences for his own work. I must confess, I came to this psychological study having never read the work of Robert Lowell. My only familiarity with the poet came directly from the author. I heard Dr. Jamison, a professor of psychiatry at Johns Hopkins University, Baltimore, speak several years ago at the Johns Hopkins Annual Mood Disorders Symposium about her then work-in-progress as she was researching this book. What I heard was intriguing enough that I was eager to read and review a long and solid book about a great poet whose work I had never read.

As I began “Setting The River On Fire,” my first thought was that the writing itself was astounding. Dr. Jamison’s words flow, her metaphors never fall flat or feel artificial, the ride itself is lovely. I looked for a few lines to quote as an example, and I was left at a standstill. One line was more gracious than the next. I finally settled on the quote I used at the beginning of this piece, benignly chosen from page 403 because it encapsulated not just the beautiful writing but a synopsis of who Lowell was and what he had achieved, set in the context of attempted differentiation between the man, the madness, and the interplay of the two.

Dr. Jamison’s research on Lowell’s life is nothing short of astounding and was clearly a labor that took both sustained passion and years of her time. Dr. Jamison quoted the poet at length. She is an expert on his many volumes of poetry and prose, as well as his life and loves – three marriages and many intimate friendships – documented through letters and conversations. In addition, she quoted many other poets as examples of how their work influenced Lowell. Beyond the literature and correspondence, Dr. Jamison interviewed those who knew Lowell well. She unearthed his medical and psychiatric records, and she plotted out the course of his life in an uncanny way, linking so much of his work to the ebbs and flows of his illness. My only “criticism” of the book would be in how extensive it is. She sometimes makes a point by quoting several sources, each of whom drive at the same idea. It makes for very strong rhetoric.

Dr. Miller, who practices in Baltimore, is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

Robert Lowell knew civic valor. Sixteen times and more he had been down on his knees in madness, he said. Sixteen times and more he had gotten up. He had gone back to his work, entered back into life. He had faced down uncertainty and madness, had created new forms when pushed to stay with the old, had brought back imaginative order from chaos. It was a different kind of courage, this civic courage, and the rules of engagement were unclear. Lowell’s life, as his daughter observed, was a messy one, difficult for him and for those who knew him. But it was lived with iron, and often with grace. He kept always in the front of his mind what he thought he ought to be, even when he couldn’t be it; he believed in what his country could be, even if it wasn’t. He worked hard at his art.

–Kay Redfield Jamison, PhD, in “Robert Lowell, Setting the River on Fire: A Study of Genius, Mania, and Character” (New York: Alfred A. Knopf, 2017).

Lowell, who lived from 1917 to 1977, was a two-time Pulitzer Prize winner, deemed to be the greatest American poet of his time. He studied the classics and was obsessed with Napoleon as a child, and he drew on the work of other great poets and classicists as influences for his own work. I must confess, I came to this psychological study having never read the work of Robert Lowell. My only familiarity with the poet came directly from the author. I heard Dr. Jamison, a professor of psychiatry at Johns Hopkins University, Baltimore, speak several years ago at the Johns Hopkins Annual Mood Disorders Symposium about her then work-in-progress as she was researching this book. What I heard was intriguing enough that I was eager to read and review a long and solid book about a great poet whose work I had never read.

As I began “Setting The River On Fire,” my first thought was that the writing itself was astounding. Dr. Jamison’s words flow, her metaphors never fall flat or feel artificial, the ride itself is lovely. I looked for a few lines to quote as an example, and I was left at a standstill. One line was more gracious than the next. I finally settled on the quote I used at the beginning of this piece, benignly chosen from page 403 because it encapsulated not just the beautiful writing but a synopsis of who Lowell was and what he had achieved, set in the context of attempted differentiation between the man, the madness, and the interplay of the two.

Dr. Jamison’s research on Lowell’s life is nothing short of astounding and was clearly a labor that took both sustained passion and years of her time. Dr. Jamison quoted the poet at length. She is an expert on his many volumes of poetry and prose, as well as his life and loves – three marriages and many intimate friendships – documented through letters and conversations. In addition, she quoted many other poets as examples of how their work influenced Lowell. Beyond the literature and correspondence, Dr. Jamison interviewed those who knew Lowell well. She unearthed his medical and psychiatric records, and she plotted out the course of his life in an uncanny way, linking so much of his work to the ebbs and flows of his illness. My only “criticism” of the book would be in how extensive it is. She sometimes makes a point by quoting several sources, each of whom drive at the same idea. It makes for very strong rhetoric.

Dr. Miller, who practices in Baltimore, is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

Robert Lowell knew civic valor. Sixteen times and more he had been down on his knees in madness, he said. Sixteen times and more he had gotten up. He had gone back to his work, entered back into life. He had faced down uncertainty and madness, had created new forms when pushed to stay with the old, had brought back imaginative order from chaos. It was a different kind of courage, this civic courage, and the rules of engagement were unclear. Lowell’s life, as his daughter observed, was a messy one, difficult for him and for those who knew him. But it was lived with iron, and often with grace. He kept always in the front of his mind what he thought he ought to be, even when he couldn’t be it; he believed in what his country could be, even if it wasn’t. He worked hard at his art.

–Kay Redfield Jamison, PhD, in “Robert Lowell, Setting the River on Fire: A Study of Genius, Mania, and Character” (New York: Alfred A. Knopf, 2017).

Lowell, who lived from 1917 to 1977, was a two-time Pulitzer Prize winner, deemed to be the greatest American poet of his time. He studied the classics and was obsessed with Napoleon as a child, and he drew on the work of other great poets and classicists as influences for his own work. I must confess, I came to this psychological study having never read the work of Robert Lowell. My only familiarity with the poet came directly from the author. I heard Dr. Jamison, a professor of psychiatry at Johns Hopkins University, Baltimore, speak several years ago at the Johns Hopkins Annual Mood Disorders Symposium about her then work-in-progress as she was researching this book. What I heard was intriguing enough that I was eager to read and review a long and solid book about a great poet whose work I had never read.

As I began “Setting The River On Fire,” my first thought was that the writing itself was astounding. Dr. Jamison’s words flow, her metaphors never fall flat or feel artificial, the ride itself is lovely. I looked for a few lines to quote as an example, and I was left at a standstill. One line was more gracious than the next. I finally settled on the quote I used at the beginning of this piece, benignly chosen from page 403 because it encapsulated not just the beautiful writing but a synopsis of who Lowell was and what he had achieved, set in the context of attempted differentiation between the man, the madness, and the interplay of the two.

Dr. Jamison’s research on Lowell’s life is nothing short of astounding and was clearly a labor that took both sustained passion and years of her time. Dr. Jamison quoted the poet at length. She is an expert on his many volumes of poetry and prose, as well as his life and loves – three marriages and many intimate friendships – documented through letters and conversations. In addition, she quoted many other poets as examples of how their work influenced Lowell. Beyond the literature and correspondence, Dr. Jamison interviewed those who knew Lowell well. She unearthed his medical and psychiatric records, and she plotted out the course of his life in an uncanny way, linking so much of his work to the ebbs and flows of his illness. My only “criticism” of the book would be in how extensive it is. She sometimes makes a point by quoting several sources, each of whom drive at the same idea. It makes for very strong rhetoric.

Dr. Miller, who practices in Baltimore, is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care,” (Baltimore: Johns Hopkins University Press, 2016).

As chair of the American Academy of Dermatology’s Patient Access and Payer Relations Committee, I traveled around the United States for three years with other well-versed dermatologists and explained the value of dermatology to insurance company medical directors (thanks to James Zalla, Scott Collins, Howard Rogers, Alexa Kimball, Clifford Lober, Sabra Sullivan, Mark Lebwohl, Beth Lertzman, Bruce Brod, Carrie Kovarik, Brent Moody, George Hruza, and Carl Johnson).

We showed them the statistics, clinical guidelines, and clinical photos and explained how cost effective dermatologists are in treating skin disease. We argued against using blunt tools, like average provider expense, as a proxy for quality. I thought it was a pretty compelling story, but the medical directors always asked for a reproducible quality metric. Almost no one in specialty medicine has reproducible quality metrics, and these are very difficult to develop.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

As chair of the American Academy of Dermatology’s Patient Access and Payer Relations Committee, I traveled around the United States for three years with other well-versed dermatologists and explained the value of dermatology to insurance company medical directors (thanks to James Zalla, Scott Collins, Howard Rogers, Alexa Kimball, Clifford Lober, Sabra Sullivan, Mark Lebwohl, Beth Lertzman, Bruce Brod, Carrie Kovarik, Brent Moody, George Hruza, and Carl Johnson).

We showed them the statistics, clinical guidelines, and clinical photos and explained how cost effective dermatologists are in treating skin disease. We argued against using blunt tools, like average provider expense, as a proxy for quality. I thought it was a pretty compelling story, but the medical directors always asked for a reproducible quality metric. Almost no one in specialty medicine has reproducible quality metrics, and these are very difficult to develop.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

As chair of the American Academy of Dermatology’s Patient Access and Payer Relations Committee, I traveled around the United States for three years with other well-versed dermatologists and explained the value of dermatology to insurance company medical directors (thanks to James Zalla, Scott Collins, Howard Rogers, Alexa Kimball, Clifford Lober, Sabra Sullivan, Mark Lebwohl, Beth Lertzman, Bruce Brod, Carrie Kovarik, Brent Moody, George Hruza, and Carl Johnson).

We showed them the statistics, clinical guidelines, and clinical photos and explained how cost effective dermatologists are in treating skin disease. We argued against using blunt tools, like average provider expense, as a proxy for quality. I thought it was a pretty compelling story, but the medical directors always asked for a reproducible quality metric. Almost no one in specialty medicine has reproducible quality metrics, and these are very difficult to develop.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].

The US Census Bureau predicts that more than half of the country’s population will identify as a race other than non-Hispanic white by the year 2044.In 2014, the US population was 62.2% non-Hispanic white, and the projected figure for 2060 is 43.6%.¹ However, most physicians currently are informed by research that is generalized from a study population of primarily white males.² Disparities also exist among the physician population where black individuals and Latinos are underrepresented.³ These differences have inspired dermatologists to develop methods to address the need for parity among patients with skin of color. Both ethnic skin centers and the Skin of Color Society (SOCS) have been established since the turn of the millennium to improve disparities and prepare for the future. The efforts and impact of SOCS are widening since its inception and chronicle one approach to broadening the scope of the specialty of dermatology.

Established in 2004 by dermatologist Susan C. Taylor, MD (Philadelphia, Pennsylvania), SOCS provides educational support to health care providers, the media, the legislature, third parties (eg, insurance organizations), and the general public on dermatologic health for patients with skin of color. The society is organized into committees that represent the multifaceted aspects of the organization. It also stimulates and endorses an increase in scientific knowledge through basic science and clinical, surgical, and cosmetic research.⁴

Scientific, research, mentorship, professional development, national and international outreach, patient education, and technology and media committees within SOCS, as well as a newly formed diversity in action task force, uphold the mission of the society. The scientific committee, one of the organization’s major committees, plans the annual symposium. The annual symposium, which immediately precedes the Annual Meeting of the American Academy of Dermatology, acts as a central educational symposium for dermatologists (both domestic and international), residents, students, and other scientists to present data on unique properties, statistics, and diseases associated with individuals with ethnic skin. New research, perspectives, and interests are shared with an audience of physicians, research fellows, residents, and students who are also the presenters of topics relevant to skin of color such as cutaneous T-cell lymphomas/mycosis fungoides in black individuals, central centrifugal cicatricial alopecia (CCCA), pigmentary disorders in Brazilians, and many others. There is an emphasis on allowing learners to present their research in a comfortable and constructive setting, and these shorter talks are interspersed with experts who deliver cutting-edge lectures in their specialty area.⁴

Each year during the SOCS symposium, the SOCS Research Award is endowed to a dermatology resident, fellow, or young dermatologist within the first 8 years of postgraduate training. The research committee oversees the selection of the SOCS Research Award. Prior recipients of the award have explored topics such as genetic causes of keloid formation or CCCA, epigenetic changes in ethnic skin during skin aging, and development of a vitiligo-specific quality-of-life scale.⁴

Another key mission of SOCS is to foster the growth of younger dermatologists interested in skin of color via mentorships; SOCS has a mentorship committee dedicated to engaging in this effort. Dermatology residents or young dermatologists who are within 3 years of finishing residency can work with a SOCS-approved mentor to develop knowledge, skills, and networking in the skin of color realm. Research is encouraged, and 3 to 4 professional development meetings (both in person or online) help set objectives. The professional development committee also coordinates efforts to offer young dermatologists opportunities to work with experienced mentors and further partnerships with existing members.⁴

The national and international outreach committee acts as a liaison between organizations abroad and those based in the United States. The patient education committee strives to improve public knowledge about dermatologic diseases that affect individuals with skin of color. Ethnic patients often have poor access to medical information, and sometimes adequate medical information does not exist in the current searchable medical literature. The SOCS website (http://skinofcolorsociety.org/) offers an entire section on dermatology education with succinct, patient-friendly prose on diseases such as acne in skin of color, CCCA, eczema, melanoma, melasma, sun protection, tinea capitis, and more; the website also includes educational videos, blogs, and a central location for useful links to other dermatology organizations that may be of interest to both members and patients who use the site. Maintenance of the website and the SOCS media day fall under the purview of the technology and media committee. There have been 2 media days thus far that have given voice to sun safety and skin cancer in individuals with skin of color as well as hair health and cosmetic treatments for patients with pigmented skin. The content for the media days is provided by SOCS experts to national magazine editors and beauty bloggers to raise awareness about these issues and get the message to the public.⁴

The diversity in action task force is a new committee that is tasked with addressing training for individuals of diverse ethnicities and backgrounds for health care careers at every level, ranging from middle school to dermatology residency. Resources to help those applying to medical school and current medical students interested in dermatology as well as those applying for dermatology residency are being developed for students at all stages of their academic careers. The middle school to undergraduate educational levels will encompass general guidelines for success; the medical school level will focus on students taking the appropriate steps to enter dermatology residency. The task force also will act as a liaison through existing student groups, such as the Student National Medical Association, Minority Association of Premedical Students, Latino Medical Student Association, Dermatology Interest Group Association, and more to reach learners at critical stages in their academic development.⁴The society plays an important role in the educational process for dermatologists at all levels. Although this organization is critical in increasing knowledge of treatment of individuals with skin of color in research, clinical practice, and the public domain, the hope is that SOCS will continue to reach new members of the dermatology community. As a group that embraces the onus to improve skin of color education, the members of SOCS know that there is still much to do to increase awareness among the public as well as dermatology residents and dermatologists practicing in geographical regions that are not ethnically diverse. There are many reasons that both cultural competence and knowledge of skin of color in dermatology will be important as the United States becomes increasingly diverse, and SOCS is at the forefront of this effort. Looking to the future, the goals of SOCS really are the goals of dermatology, which are to continue to deliver the best care to all patients and to continue to improve our specialty with new techniques and medications for all patients who need care.

The US Census Bureau predicts that more than half of the country’s population will identify as a race other than non-Hispanic white by the year 2044.In 2014, the US population was 62.2% non-Hispanic white, and the projected figure for 2060 is 43.6%.¹ However, most physicians currently are informed by research that is generalized from a study population of primarily white males.² Disparities also exist among the physician population where black individuals and Latinos are underrepresented.³ These differences have inspired dermatologists to develop methods to address the need for parity among patients with skin of color. Both ethnic skin centers and the Skin of Color Society (SOCS) have been established since the turn of the millennium to improve disparities and prepare for the future. The efforts and impact of SOCS are widening since its inception and chronicle one approach to broadening the scope of the specialty of dermatology.

Established in 2004 by dermatologist Susan C. Taylor, MD (Philadelphia, Pennsylvania), SOCS provides educational support to health care providers, the media, the legislature, third parties (eg, insurance organizations), and the general public on dermatologic health for patients with skin of color. The society is organized into committees that represent the multifaceted aspects of the organization. It also stimulates and endorses an increase in scientific knowledge through basic science and clinical, surgical, and cosmetic research.⁴

Scientific, research, mentorship, professional development, national and international outreach, patient education, and technology and media committees within SOCS, as well as a newly formed diversity in action task force, uphold the mission of the society. The scientific committee, one of the organization’s major committees, plans the annual symposium. The annual symposium, which immediately precedes the Annual Meeting of the American Academy of Dermatology, acts as a central educational symposium for dermatologists (both domestic and international), residents, students, and other scientists to present data on unique properties, statistics, and diseases associated with individuals with ethnic skin. New research, perspectives, and interests are shared with an audience of physicians, research fellows, residents, and students who are also the presenters of topics relevant to skin of color such as cutaneous T-cell lymphomas/mycosis fungoides in black individuals, central centrifugal cicatricial alopecia (CCCA), pigmentary disorders in Brazilians, and many others. There is an emphasis on allowing learners to present their research in a comfortable and constructive setting, and these shorter talks are interspersed with experts who deliver cutting-edge lectures in their specialty area.⁴

Each year during the SOCS symposium, the SOCS Research Award is endowed to a dermatology resident, fellow, or young dermatologist within the first 8 years of postgraduate training. The research committee oversees the selection of the SOCS Research Award. Prior recipients of the award have explored topics such as genetic causes of keloid formation or CCCA, epigenetic changes in ethnic skin during skin aging, and development of a vitiligo-specific quality-of-life scale.⁴

Another key mission of SOCS is to foster the growth of younger dermatologists interested in skin of color via mentorships; SOCS has a mentorship committee dedicated to engaging in this effort. Dermatology residents or young dermatologists who are within 3 years of finishing residency can work with a SOCS-approved mentor to develop knowledge, skills, and networking in the skin of color realm. Research is encouraged, and 3 to 4 professional development meetings (both in person or online) help set objectives. The professional development committee also coordinates efforts to offer young dermatologists opportunities to work with experienced mentors and further partnerships with existing members.⁴

The national and international outreach committee acts as a liaison between organizations abroad and those based in the United States. The patient education committee strives to improve public knowledge about dermatologic diseases that affect individuals with skin of color. Ethnic patients often have poor access to medical information, and sometimes adequate medical information does not exist in the current searchable medical literature. The SOCS website (http://skinofcolorsociety.org/) offers an entire section on dermatology education with succinct, patient-friendly prose on diseases such as acne in skin of color, CCCA, eczema, melanoma, melasma, sun protection, tinea capitis, and more; the website also includes educational videos, blogs, and a central location for useful links to other dermatology organizations that may be of interest to both members and patients who use the site. Maintenance of the website and the SOCS media day fall under the purview of the technology and media committee. There have been 2 media days thus far that have given voice to sun safety and skin cancer in individuals with skin of color as well as hair health and cosmetic treatments for patients with pigmented skin. The content for the media days is provided by SOCS experts to national magazine editors and beauty bloggers to raise awareness about these issues and get the message to the public.⁴

The diversity in action task force is a new committee that is tasked with addressing training for individuals of diverse ethnicities and backgrounds for health care careers at every level, ranging from middle school to dermatology residency. Resources to help those applying to medical school and current medical students interested in dermatology as well as those applying for dermatology residency are being developed for students at all stages of their academic careers. The middle school to undergraduate educational levels will encompass general guidelines for success; the medical school level will focus on students taking the appropriate steps to enter dermatology residency. The task force also will act as a liaison through existing student groups, such as the Student National Medical Association, Minority Association of Premedical Students, Latino Medical Student Association, Dermatology Interest Group Association, and more to reach learners at critical stages in their academic development.⁴The society plays an important role in the educational process for dermatologists at all levels. Although this organization is critical in increasing knowledge of treatment of individuals with skin of color in research, clinical practice, and the public domain, the hope is that SOCS will continue to reach new members of the dermatology community. As a group that embraces the onus to improve skin of color education, the members of SOCS know that there is still much to do to increase awareness among the public as well as dermatology residents and dermatologists practicing in geographical regions that are not ethnically diverse. There are many reasons that both cultural competence and knowledge of skin of color in dermatology will be important as the United States becomes increasingly diverse, and SOCS is at the forefront of this effort. Looking to the future, the goals of SOCS really are the goals of dermatology, which are to continue to deliver the best care to all patients and to continue to improve our specialty with new techniques and medications for all patients who need care.

The US Census Bureau predicts that more than half of the country’s population will identify as a race other than non-Hispanic white by the year 2044.In 2014, the US population was 62.2% non-Hispanic white, and the projected figure for 2060 is 43.6%.¹ However, most physicians currently are informed by research that is generalized from a study population of primarily white males.² Disparities also exist among the physician population where black individuals and Latinos are underrepresented.³ These differences have inspired dermatologists to develop methods to address the need for parity among patients with skin of color. Both ethnic skin centers and the Skin of Color Society (SOCS) have been established since the turn of the millennium to improve disparities and prepare for the future. The efforts and impact of SOCS are widening since its inception and chronicle one approach to broadening the scope of the specialty of dermatology.

Established in 2004 by dermatologist Susan C. Taylor, MD (Philadelphia, Pennsylvania), SOCS provides educational support to health care providers, the media, the legislature, third parties (eg, insurance organizations), and the general public on dermatologic health for patients with skin of color. The society is organized into committees that represent the multifaceted aspects of the organization. It also stimulates and endorses an increase in scientific knowledge through basic science and clinical, surgical, and cosmetic research.⁴

Scientific, research, mentorship, professional development, national and international outreach, patient education, and technology and media committees within SOCS, as well as a newly formed diversity in action task force, uphold the mission of the society. The scientific committee, one of the organization’s major committees, plans the annual symposium. The annual symposium, which immediately precedes the Annual Meeting of the American Academy of Dermatology, acts as a central educational symposium for dermatologists (both domestic and international), residents, students, and other scientists to present data on unique properties, statistics, and diseases associated with individuals with ethnic skin. New research, perspectives, and interests are shared with an audience of physicians, research fellows, residents, and students who are also the presenters of topics relevant to skin of color such as cutaneous T-cell lymphomas/mycosis fungoides in black individuals, central centrifugal cicatricial alopecia (CCCA), pigmentary disorders in Brazilians, and many others. There is an emphasis on allowing learners to present their research in a comfortable and constructive setting, and these shorter talks are interspersed with experts who deliver cutting-edge lectures in their specialty area.⁴

Each year during the SOCS symposium, the SOCS Research Award is endowed to a dermatology resident, fellow, or young dermatologist within the first 8 years of postgraduate training. The research committee oversees the selection of the SOCS Research Award. Prior recipients of the award have explored topics such as genetic causes of keloid formation or CCCA, epigenetic changes in ethnic skin during skin aging, and development of a vitiligo-specific quality-of-life scale.⁴

Another key mission of SOCS is to foster the growth of younger dermatologists interested in skin of color via mentorships; SOCS has a mentorship committee dedicated to engaging in this effort. Dermatology residents or young dermatologists who are within 3 years of finishing residency can work with a SOCS-approved mentor to develop knowledge, skills, and networking in the skin of color realm. Research is encouraged, and 3 to 4 professional development meetings (both in person or online) help set objectives. The professional development committee also coordinates efforts to offer young dermatologists opportunities to work with experienced mentors and further partnerships with existing members.⁴

The national and international outreach committee acts as a liaison between organizations abroad and those based in the United States. The patient education committee strives to improve public knowledge about dermatologic diseases that affect individuals with skin of color. Ethnic patients often have poor access to medical information, and sometimes adequate medical information does not exist in the current searchable medical literature. The SOCS website (http://skinofcolorsociety.org/) offers an entire section on dermatology education with succinct, patient-friendly prose on diseases such as acne in skin of color, CCCA, eczema, melanoma, melasma, sun protection, tinea capitis, and more; the website also includes educational videos, blogs, and a central location for useful links to other dermatology organizations that may be of interest to both members and patients who use the site. Maintenance of the website and the SOCS media day fall under the purview of the technology and media committee. There have been 2 media days thus far that have given voice to sun safety and skin cancer in individuals with skin of color as well as hair health and cosmetic treatments for patients with pigmented skin. The content for the media days is provided by SOCS experts to national magazine editors and beauty bloggers to raise awareness about these issues and get the message to the public.⁴

The diversity in action task force is a new committee that is tasked with addressing training for individuals of diverse ethnicities and backgrounds for health care careers at every level, ranging from middle school to dermatology residency. Resources to help those applying to medical school and current medical students interested in dermatology as well as those applying for dermatology residency are being developed for students at all stages of their academic careers. The middle school to undergraduate educational levels will encompass general guidelines for success; the medical school level will focus on students taking the appropriate steps to enter dermatology residency. The task force also will act as a liaison through existing student groups, such as the Student National Medical Association, Minority Association of Premedical Students, Latino Medical Student Association, Dermatology Interest Group Association, and more to reach learners at critical stages in their academic development.⁴The society plays an important role in the educational process for dermatologists at all levels. Although this organization is critical in increasing knowledge of treatment of individuals with skin of color in research, clinical practice, and the public domain, the hope is that SOCS will continue to reach new members of the dermatology community. As a group that embraces the onus to improve skin of color education, the members of SOCS know that there is still much to do to increase awareness among the public as well as dermatology residents and dermatologists practicing in geographical regions that are not ethnically diverse. There are many reasons that both cultural competence and knowledge of skin of color in dermatology will be important as the United States becomes increasingly diverse, and SOCS is at the forefront of this effort. Looking to the future, the goals of SOCS really are the goals of dermatology, which are to continue to deliver the best care to all patients and to continue to improve our specialty with new techniques and medications for all patients who need care.

When we started publishing the EHR Report several years ago, our very first column was a brief overview of a new federal incentive program known as Meaningful Use. At that time, the prospect of receiving thousands of dollars to adopt an electronic health record seemed exciting, and our dream of health care’s digital future appeared to be coming true.

Best of all, we as physicians would be paid to simply embrace it!

Unfortunately, it wasn’t long before that dream (for many at least) devolved into a nightmare. Electronic health records hadn’t been designed to fit into physicians’ long-established work flows, and just weren’t up to the challenge of increasing efficiency. In fact, EHRs quickly became virtual taskmasters, leaving physicians mired in a sea of clicks and slow-moving screens.

Frankly speaking, Meaningful Use hasn’t lived up to its promises. With measures obligating users to fill in a myriad of check-boxes and document often irrelevant information, the program has seemed less like an incentive and more like a penance.

To top it off, the all-or-nothing requirement has meant that – after a year of hard work – providers missing even one goal receive no payments at all, and instead are assessed financial penalties!

All of this has appropriately led physicians to become jaded – not excited – about the digital future.

Thankfully, there is reason for hope: 2017 marks the end of Meaningful Use under Medicare.

What’s new for 2017?

MACRA has a much grander scope and sets an even loftier goal: transforming care delivery to achieve better value and ultimately healthier patients.

Now, in case you’re not already confused by the number of programs cited above, there is one more we need to mention to explain the future of EHR incentives: the Merit-based Incentive Payment System, or MIPS, one of two tracks in the Quality Payment Program.

The majority of Medicare providers will choose this track, which focuses on four major components to determine reimbursement incentives: quality, improvement activities, advancing care information, and cost.

Depending on performance in each of these areas, participants will see a variable payment adjustment (upward or downward) in subsequent years (this is a percentage of Medicare payments that increases annually, beginning with a possible +/– 4% in 2019, to a maximum of +/– 9% in 2022).

Providers under MIPS who choose to attest for this year can select from three levels of participation:

1. Test: submission of only a minimal amount of 2017 data (such as one or two measures) to avoid penalty.

2. Partial: submission of 90 days’ worth of data, which may result in a neutral or positive payment adjustment (and may even earn the max adjustment).

3. Full: submission of a full year of data.

Here’s an example of how this will work: A provider who attests in March 2018 for the full 2017 year and does really well could see up to a 4% incentive bonus on Medicare payments in 2019. A provider who chooses not to attest would receive a penalty of 4%.

It’s worth noting here that MIPS expands upon the inclusion criteria set for Meaningful Use under Medicare. Medicare Part B clinicians are eligible to participate if they bill $30,000 in charges and see at least 100 Medicare patients annually. MIPS also broadens the list of eligible provider types. Physicians, nurse practitioners, physician assistants, clinical nurse specialists, and certified registered nurse anesthetists are all able to attest.

Advancing Care Information

Under MIPS, Meaningful Use is replaced by an initiative called Advancing Care Information, or ACI. In this new incarnation, there are fewer required measures, and they are much less onerous than they were under the former program.

Also, there are a number of optional measures. A provider may choose to attest to these nonrequired metrics to improve his or her chances of achieving the maximum incentive, but it isn’t necessary. There are also bonus measures involving public health registry reporting. These are optional but a sure bet to increase incentives. In all, the ACI component composes 25% of a provider’s final MIPS score.

For 2017, participants are able to choose one of two tracks in the ACI program, depending on their EHR’s certification year. (If you are confused by this or don’t know the status of your product, check with your vendor or go to https://chpl.healthit.gov to figure it out).

Providers with technology certified to the 2015 edition (or a combination of technologies from the 2014 and 2015 editions) can fully attest to the ACI objectives and measures or elect to use the transition objectives and measures. Those with 2014 edition software must choose the transition measures.

We will cover the specific measures in a future column, but for now we’ll note that both tracks are very similar and focus on protecting patient data, encouraging patient access to their own records, and sharing information electronically with other providers.

Rekindling the dream

We are certain that changing legislation won’t solve all of the problems inherent in current EHR systems, but we are always encouraged by any attempt to reduce the documentation burden on physicians. By eschewing thresholds, eliminating the all-or-nothing requirement, and reducing the number of required measures, the ACI program does seem to shift the focus away from volume and toward value.

That alone has the potential to restore our hope of a brighter future, and make our use of electronic health records significantly more meaningful.
 

Note: To learn more about Quality Payment Program and MIPS, we highly recommend an online resource published by the Centers for Medicare & Medicaid Services that is easy to follow and is full of useful information. It can be found at https://qpp.cms.gov.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.

When we started publishing the EHR Report several years ago, our very first column was a brief overview of a new federal incentive program known as Meaningful Use. At that time, the prospect of receiving thousands of dollars to adopt an electronic health record seemed exciting, and our dream of health care’s digital future appeared to be coming true.

Best of all, we as physicians would be paid to simply embrace it!

Unfortunately, it wasn’t long before that dream (for many at least) devolved into a nightmare. Electronic health records hadn’t been designed to fit into physicians’ long-established work flows, and just weren’t up to the challenge of increasing efficiency. In fact, EHRs quickly became virtual taskmasters, leaving physicians mired in a sea of clicks and slow-moving screens.

Frankly speaking, Meaningful Use hasn’t lived up to its promises. With measures obligating users to fill in a myriad of check-boxes and document often irrelevant information, the program has seemed less like an incentive and more like a penance.

To top it off, the all-or-nothing requirement has meant that – after a year of hard work – providers missing even one goal receive no payments at all, and instead are assessed financial penalties!

All of this has appropriately led physicians to become jaded – not excited – about the digital future.

Thankfully, there is reason for hope: 2017 marks the end of Meaningful Use under Medicare.

What’s new for 2017?

MACRA has a much grander scope and sets an even loftier goal: transforming care delivery to achieve better value and ultimately healthier patients.

Now, in case you’re not already confused by the number of programs cited above, there is one more we need to mention to explain the future of EHR incentives: the Merit-based Incentive Payment System, or MIPS, one of two tracks in the Quality Payment Program.

The majority of Medicare providers will choose this track, which focuses on four major components to determine reimbursement incentives: quality, improvement activities, advancing care information, and cost.

Depending on performance in each of these areas, participants will see a variable payment adjustment (upward or downward) in subsequent years (this is a percentage of Medicare payments that increases annually, beginning with a possible +/– 4% in 2019, to a maximum of +/– 9% in 2022).

Providers under MIPS who choose to attest for this year can select from three levels of participation:

1. Test: submission of only a minimal amount of 2017 data (such as one or two measures) to avoid penalty.

2. Partial: submission of 90 days’ worth of data, which may result in a neutral or positive payment adjustment (and may even earn the max adjustment).

3. Full: submission of a full year of data.

Here’s an example of how this will work: A provider who attests in March 2018 for the full 2017 year and does really well could see up to a 4% incentive bonus on Medicare payments in 2019. A provider who chooses not to attest would receive a penalty of 4%.

It’s worth noting here that MIPS expands upon the inclusion criteria set for Meaningful Use under Medicare. Medicare Part B clinicians are eligible to participate if they bill $30,000 in charges and see at least 100 Medicare patients annually. MIPS also broadens the list of eligible provider types. Physicians, nurse practitioners, physician assistants, clinical nurse specialists, and certified registered nurse anesthetists are all able to attest.

Advancing Care Information

Under MIPS, Meaningful Use is replaced by an initiative called Advancing Care Information, or ACI. In this new incarnation, there are fewer required measures, and they are much less onerous than they were under the former program.

Also, there are a number of optional measures. A provider may choose to attest to these nonrequired metrics to improve his or her chances of achieving the maximum incentive, but it isn’t necessary. There are also bonus measures involving public health registry reporting. These are optional but a sure bet to increase incentives. In all, the ACI component composes 25% of a provider’s final MIPS score.

For 2017, participants are able to choose one of two tracks in the ACI program, depending on their EHR’s certification year. (If you are confused by this or don’t know the status of your product, check with your vendor or go to https://chpl.healthit.gov to figure it out).

Providers with technology certified to the 2015 edition (or a combination of technologies from the 2014 and 2015 editions) can fully attest to the ACI objectives and measures or elect to use the transition objectives and measures. Those with 2014 edition software must choose the transition measures.

We will cover the specific measures in a future column, but for now we’ll note that both tracks are very similar and focus on protecting patient data, encouraging patient access to their own records, and sharing information electronically with other providers.

Rekindling the dream

We are certain that changing legislation won’t solve all of the problems inherent in current EHR systems, but we are always encouraged by any attempt to reduce the documentation burden on physicians. By eschewing thresholds, eliminating the all-or-nothing requirement, and reducing the number of required measures, the ACI program does seem to shift the focus away from volume and toward value.

That alone has the potential to restore our hope of a brighter future, and make our use of electronic health records significantly more meaningful.
 

Note: To learn more about Quality Payment Program and MIPS, we highly recommend an online resource published by the Centers for Medicare & Medicaid Services that is easy to follow and is full of useful information. It can be found at https://qpp.cms.gov.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.

When we started publishing the EHR Report several years ago, our very first column was a brief overview of a new federal incentive program known as Meaningful Use. At that time, the prospect of receiving thousands of dollars to adopt an electronic health record seemed exciting, and our dream of health care’s digital future appeared to be coming true.

Best of all, we as physicians would be paid to simply embrace it!

Unfortunately, it wasn’t long before that dream (for many at least) devolved into a nightmare. Electronic health records hadn’t been designed to fit into physicians’ long-established work flows, and just weren’t up to the challenge of increasing efficiency. In fact, EHRs quickly became virtual taskmasters, leaving physicians mired in a sea of clicks and slow-moving screens.

Frankly speaking, Meaningful Use hasn’t lived up to its promises. With measures obligating users to fill in a myriad of check-boxes and document often irrelevant information, the program has seemed less like an incentive and more like a penance.

To top it off, the all-or-nothing requirement has meant that – after a year of hard work – providers missing even one goal receive no payments at all, and instead are assessed financial penalties!

All of this has appropriately led physicians to become jaded – not excited – about the digital future.

Thankfully, there is reason for hope: 2017 marks the end of Meaningful Use under Medicare.

What’s new for 2017?

MACRA has a much grander scope and sets an even loftier goal: transforming care delivery to achieve better value and ultimately healthier patients.

Now, in case you’re not already confused by the number of programs cited above, there is one more we need to mention to explain the future of EHR incentives: the Merit-based Incentive Payment System, or MIPS, one of two tracks in the Quality Payment Program.

The majority of Medicare providers will choose this track, which focuses on four major components to determine reimbursement incentives: quality, improvement activities, advancing care information, and cost.

Depending on performance in each of these areas, participants will see a variable payment adjustment (upward or downward) in subsequent years (this is a percentage of Medicare payments that increases annually, beginning with a possible +/– 4% in 2019, to a maximum of +/– 9% in 2022).

Providers under MIPS who choose to attest for this year can select from three levels of participation:

1. Test: submission of only a minimal amount of 2017 data (such as one or two measures) to avoid penalty.

2. Partial: submission of 90 days’ worth of data, which may result in a neutral or positive payment adjustment (and may even earn the max adjustment).

3. Full: submission of a full year of data.

Here’s an example of how this will work: A provider who attests in March 2018 for the full 2017 year and does really well could see up to a 4% incentive bonus on Medicare payments in 2019. A provider who chooses not to attest would receive a penalty of 4%.

It’s worth noting here that MIPS expands upon the inclusion criteria set for Meaningful Use under Medicare. Medicare Part B clinicians are eligible to participate if they bill $30,000 in charges and see at least 100 Medicare patients annually. MIPS also broadens the list of eligible provider types. Physicians, nurse practitioners, physician assistants, clinical nurse specialists, and certified registered nurse anesthetists are all able to attest.

Advancing Care Information

Under MIPS, Meaningful Use is replaced by an initiative called Advancing Care Information, or ACI. In this new incarnation, there are fewer required measures, and they are much less onerous than they were under the former program.

Also, there are a number of optional measures. A provider may choose to attest to these nonrequired metrics to improve his or her chances of achieving the maximum incentive, but it isn’t necessary. There are also bonus measures involving public health registry reporting. These are optional but a sure bet to increase incentives. In all, the ACI component composes 25% of a provider’s final MIPS score.

For 2017, participants are able to choose one of two tracks in the ACI program, depending on their EHR’s certification year. (If you are confused by this or don’t know the status of your product, check with your vendor or go to https://chpl.healthit.gov to figure it out).

Providers with technology certified to the 2015 edition (or a combination of technologies from the 2014 and 2015 editions) can fully attest to the ACI objectives and measures or elect to use the transition objectives and measures. Those with 2014 edition software must choose the transition measures.

We will cover the specific measures in a future column, but for now we’ll note that both tracks are very similar and focus on protecting patient data, encouraging patient access to their own records, and sharing information electronically with other providers.

Rekindling the dream

We are certain that changing legislation won’t solve all of the problems inherent in current EHR systems, but we are always encouraged by any attempt to reduce the documentation burden on physicians. By eschewing thresholds, eliminating the all-or-nothing requirement, and reducing the number of required measures, the ACI program does seem to shift the focus away from volume and toward value.

That alone has the potential to restore our hope of a brighter future, and make our use of electronic health records significantly more meaningful.
 

Note: To learn more about Quality Payment Program and MIPS, we highly recommend an online resource published by the Centers for Medicare & Medicaid Services that is easy to follow and is full of useful information. It can be found at https://qpp.cms.gov.

Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.

Lower-intensity radiation regimens for patients with early-stage Hodgkin lymphoma (HL) did not shorten progression-free survival (PFS), according to a long-term analysis. Further, for patients with unfavorable early-stage disease, a more intense chemotherapy or radiation regimen conferred no survival benefit.

The German Hodgkin Study Group included patients with early-stage HL who had both early-stage favorable HL and early-stage unfavorable HL. Stephanie Sasse, MD, and her study group colleagues published long-term follow-up findings from multiple trials, conducted from 1993 to 2003, that evaluated risk-adapted treatment strategies to reduce radiation field size and chemotherapy intensity, “aiming at achieving sufficient tumor control while potentially reducing treatment-associated toxicity,” wrote Dr. Sasse and her colleagues of the University Hospital of Cologne (Ger.) (J Clin Oncol. 2017 Apr 18. doi: JCO2016709410).

Trials in favorable HL

Of the 627 patients in the HD7 trial in patients with favorable HL, combined-modality therapy resulted in better rates of PFS (73%) over a 15-year period, compared with extended-field radiotherapy (RT) alone (52%) (hazard ratio, 0.5; 95% confidence interval, 0.3-0.6; P less than 0.001). Another study, called HD10, was in early-stage favorable HL patients. It compared a lower-intensity regimen of two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 20 Gy involved-field RT with a four-cycle ABVD regimen combined with 30 Gy involved-field RT. The 1,190-patient study achieved a median follow-up of 98 months, finding that the less-intense regimen was not inferior with an identical 10-year PFS of 87% in both arms (HR 1.0; 95% CI 0.6-1.5). Overall survival (OS) was nearly identical as well, at 94% in each arm (HR 0.9; 95% CI, 0.5-1.6).

Both trials HD7 and HD10 tracked the incidence of secondary neoplasias and detected no significant differences between groups, though there was a nonsignificant trend toward more secondary neoplasias for the HD7 patients who received extended-field radiotherapy. These analyses “strongly support the current risk-adapted treatment strategy in early-stage favorable HL,” wrote Dr. Sasse and her coinvestigators.

Trials in unfavorable HL

The HD8 trial enrolled 1,064 patients and followed them for a median 153 months to compare the efficacy of involved-field RT with extended-field RT, finding involved-field RT noninferior for PFS (HR, 1.0; 95% CI, 0.8-1.2). However, the overall 15-year PFS rate of 74% and OS rate of 82% “leave room for improvement,” said the investigators.

Finally, trial HD11 compared two different chemotherapy regimens and two different radiation doses. Patients received four cycles of either ABVD or bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone at baseline dosage (BEACOPP_baseline), followed by 20 or 30 Gy involved-field RT. The study, which followed 1,395 patients for a median of 106 months, had a 2x2 factorial design.

Following the HD11 cohort longitudinally showed that BEACOPP_baseline did not confer a PFS advantage over ABVD for patients receiving the 30 Gy RT regimen (HR 1.1; 95% CI, 0.7-1.5). Nor did patients who received 20 Gy RT have significantly longer PFS with the more intense BEACOPPbaseline chemotherapy regimen (HR 0.8; 95% CI, 0.6-1.1).

Overall survival and the incidence of secondary neoplasias did not differ between trial arms in HD11, said Dr. Sasse and her coinvestigators.

To further explore whether more intense chemotherapy might result in better PFS rates for patients with early-stage unfavorable HL, Dr. Sasse and her colleagues are following long-term results from more recent trial, HD14, that combined two cycles of BEACOPP_escalated and two cycles of ABVD. More short-term toxicity was seen, but patients in this trial arm have significantly better 5-year PFS rates than do those receiving four cycles of ABVD. “The improved tumor control is a relevant outcome parameter for patients,” wrote Dr. Sasse and her colleagues.

The investigators are reserving judgment about whether more radiation exposure and higher doses of alkylating agents and etoposide may eventually result in higher rates of secondary neoplasms. “Subsequent analyses with even longer follow-up will have to confirm that the reduction of RT field size or dose indeed translates into a reduced risk of [secondary neoplasms],” they wrote.

Several of the authors reported multiple relationships with pharmaceutical companies. The study was funded by a grant from the German Cancer Aid.

[email protected]

On Twitter @karioakes

Lower-intensity radiation regimens for patients with early-stage Hodgkin lymphoma (HL) did not shorten progression-free survival (PFS), according to a long-term analysis. Further, for patients with unfavorable early-stage disease, a more intense chemotherapy or radiation regimen conferred no survival benefit.

The German Hodgkin Study Group included patients with early-stage HL who had both early-stage favorable HL and early-stage unfavorable HL. Stephanie Sasse, MD, and her study group colleagues published long-term follow-up findings from multiple trials, conducted from 1993 to 2003, that evaluated risk-adapted treatment strategies to reduce radiation field size and chemotherapy intensity, “aiming at achieving sufficient tumor control while potentially reducing treatment-associated toxicity,” wrote Dr. Sasse and her colleagues of the University Hospital of Cologne (Ger.) (J Clin Oncol. 2017 Apr 18. doi: JCO2016709410).

Trials in favorable HL

Of the 627 patients in the HD7 trial in patients with favorable HL, combined-modality therapy resulted in better rates of PFS (73%) over a 15-year period, compared with extended-field radiotherapy (RT) alone (52%) (hazard ratio, 0.5; 95% confidence interval, 0.3-0.6; P less than 0.001). Another study, called HD10, was in early-stage favorable HL patients. It compared a lower-intensity regimen of two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 20 Gy involved-field RT with a four-cycle ABVD regimen combined with 30 Gy involved-field RT. The 1,190-patient study achieved a median follow-up of 98 months, finding that the less-intense regimen was not inferior with an identical 10-year PFS of 87% in both arms (HR 1.0; 95% CI 0.6-1.5). Overall survival (OS) was nearly identical as well, at 94% in each arm (HR 0.9; 95% CI, 0.5-1.6).

Both trials HD7 and HD10 tracked the incidence of secondary neoplasias and detected no significant differences between groups, though there was a nonsignificant trend toward more secondary neoplasias for the HD7 patients who received extended-field radiotherapy. These analyses “strongly support the current risk-adapted treatment strategy in early-stage favorable HL,” wrote Dr. Sasse and her coinvestigators.

Trials in unfavorable HL

The HD8 trial enrolled 1,064 patients and followed them for a median 153 months to compare the efficacy of involved-field RT with extended-field RT, finding involved-field RT noninferior for PFS (HR, 1.0; 95% CI, 0.8-1.2). However, the overall 15-year PFS rate of 74% and OS rate of 82% “leave room for improvement,” said the investigators.

Finally, trial HD11 compared two different chemotherapy regimens and two different radiation doses. Patients received four cycles of either ABVD or bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone at baseline dosage (BEACOPP_baseline), followed by 20 or 30 Gy involved-field RT. The study, which followed 1,395 patients for a median of 106 months, had a 2x2 factorial design.

Following the HD11 cohort longitudinally showed that BEACOPP_baseline did not confer a PFS advantage over ABVD for patients receiving the 30 Gy RT regimen (HR 1.1; 95% CI, 0.7-1.5). Nor did patients who received 20 Gy RT have significantly longer PFS with the more intense BEACOPPbaseline chemotherapy regimen (HR 0.8; 95% CI, 0.6-1.1).

Overall survival and the incidence of secondary neoplasias did not differ between trial arms in HD11, said Dr. Sasse and her coinvestigators.

To further explore whether more intense chemotherapy might result in better PFS rates for patients with early-stage unfavorable HL, Dr. Sasse and her colleagues are following long-term results from more recent trial, HD14, that combined two cycles of BEACOPP_escalated and two cycles of ABVD. More short-term toxicity was seen, but patients in this trial arm have significantly better 5-year PFS rates than do those receiving four cycles of ABVD. “The improved tumor control is a relevant outcome parameter for patients,” wrote Dr. Sasse and her colleagues.

The investigators are reserving judgment about whether more radiation exposure and higher doses of alkylating agents and etoposide may eventually result in higher rates of secondary neoplasms. “Subsequent analyses with even longer follow-up will have to confirm that the reduction of RT field size or dose indeed translates into a reduced risk of [secondary neoplasms],” they wrote.

Several of the authors reported multiple relationships with pharmaceutical companies. The study was funded by a grant from the German Cancer Aid.

[email protected]

On Twitter @karioakes

Lower-intensity radiation regimens for patients with early-stage Hodgkin lymphoma (HL) did not shorten progression-free survival (PFS), according to a long-term analysis. Further, for patients with unfavorable early-stage disease, a more intense chemotherapy or radiation regimen conferred no survival benefit.

The German Hodgkin Study Group included patients with early-stage HL who had both early-stage favorable HL and early-stage unfavorable HL. Stephanie Sasse, MD, and her study group colleagues published long-term follow-up findings from multiple trials, conducted from 1993 to 2003, that evaluated risk-adapted treatment strategies to reduce radiation field size and chemotherapy intensity, “aiming at achieving sufficient tumor control while potentially reducing treatment-associated toxicity,” wrote Dr. Sasse and her colleagues of the University Hospital of Cologne (Ger.) (J Clin Oncol. 2017 Apr 18. doi: JCO2016709410).

Trials in favorable HL

Of the 627 patients in the HD7 trial in patients with favorable HL, combined-modality therapy resulted in better rates of PFS (73%) over a 15-year period, compared with extended-field radiotherapy (RT) alone (52%) (hazard ratio, 0.5; 95% confidence interval, 0.3-0.6; P less than 0.001). Another study, called HD10, was in early-stage favorable HL patients. It compared a lower-intensity regimen of two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) plus 20 Gy involved-field RT with a four-cycle ABVD regimen combined with 30 Gy involved-field RT. The 1,190-patient study achieved a median follow-up of 98 months, finding that the less-intense regimen was not inferior with an identical 10-year PFS of 87% in both arms (HR 1.0; 95% CI 0.6-1.5). Overall survival (OS) was nearly identical as well, at 94% in each arm (HR 0.9; 95% CI, 0.5-1.6).

Both trials HD7 and HD10 tracked the incidence of secondary neoplasias and detected no significant differences between groups, though there was a nonsignificant trend toward more secondary neoplasias for the HD7 patients who received extended-field radiotherapy. These analyses “strongly support the current risk-adapted treatment strategy in early-stage favorable HL,” wrote Dr. Sasse and her coinvestigators.

Trials in unfavorable HL

The HD8 trial enrolled 1,064 patients and followed them for a median 153 months to compare the efficacy of involved-field RT with extended-field RT, finding involved-field RT noninferior for PFS (HR, 1.0; 95% CI, 0.8-1.2). However, the overall 15-year PFS rate of 74% and OS rate of 82% “leave room for improvement,” said the investigators.

Finally, trial HD11 compared two different chemotherapy regimens and two different radiation doses. Patients received four cycles of either ABVD or bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone at baseline dosage (BEACOPP_baseline), followed by 20 or 30 Gy involved-field RT. The study, which followed 1,395 patients for a median of 106 months, had a 2x2 factorial design.

Following the HD11 cohort longitudinally showed that BEACOPP_baseline did not confer a PFS advantage over ABVD for patients receiving the 30 Gy RT regimen (HR 1.1; 95% CI, 0.7-1.5). Nor did patients who received 20 Gy RT have significantly longer PFS with the more intense BEACOPPbaseline chemotherapy regimen (HR 0.8; 95% CI, 0.6-1.1).

Overall survival and the incidence of secondary neoplasias did not differ between trial arms in HD11, said Dr. Sasse and her coinvestigators.

To further explore whether more intense chemotherapy might result in better PFS rates for patients with early-stage unfavorable HL, Dr. Sasse and her colleagues are following long-term results from more recent trial, HD14, that combined two cycles of BEACOPP_escalated and two cycles of ABVD. More short-term toxicity was seen, but patients in this trial arm have significantly better 5-year PFS rates than do those receiving four cycles of ABVD. “The improved tumor control is a relevant outcome parameter for patients,” wrote Dr. Sasse and her colleagues.

The investigators are reserving judgment about whether more radiation exposure and higher doses of alkylating agents and etoposide may eventually result in higher rates of secondary neoplasms. “Subsequent analyses with even longer follow-up will have to confirm that the reduction of RT field size or dose indeed translates into a reduced risk of [secondary neoplasms],” they wrote.

Several of the authors reported multiple relationships with pharmaceutical companies. The study was funded by a grant from the German Cancer Aid.

[email protected]

On Twitter @karioakes

BRUSSELS – The inability of researchers to find a biomarker that could flag a subgroup of breast cancer patients with increased responsiveness to ribociclib plus an aromatase inhibitor was “somewhat disappointing,” Philippe Bedard, MD, said at a breast cancer conference sponsored by the European Society for Medical Oncology.

Many patients who are candidates for this combination treatment, approved by the Food and Drug Administration in March 2017 for postmenopausal women with advanced breast cancer that is hormone receptor positive and HER2 negative, could also do just as well on an aromatase inhibitor alone, said Dr. Bedard, of the Princess Margaret Cancer Centre in Toronto.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

Correction, 5/6/17: An earlier version of this article misstated the citation.

BRUSSELS – The inability of researchers to find a biomarker that could flag a subgroup of breast cancer patients with increased responsiveness to ribociclib plus an aromatase inhibitor was “somewhat disappointing,” Philippe Bedard, MD, said at a breast cancer conference sponsored by the European Society for Medical Oncology.

Many patients who are candidates for this combination treatment, approved by the Food and Drug Administration in March 2017 for postmenopausal women with advanced breast cancer that is hormone receptor positive and HER2 negative, could also do just as well on an aromatase inhibitor alone, said Dr. Bedard, of the Princess Margaret Cancer Centre in Toronto.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

Correction, 5/6/17: An earlier version of this article misstated the citation.

BRUSSELS – The inability of researchers to find a biomarker that could flag a subgroup of breast cancer patients with increased responsiveness to ribociclib plus an aromatase inhibitor was “somewhat disappointing,” Philippe Bedard, MD, said at a breast cancer conference sponsored by the European Society for Medical Oncology.

Many patients who are candidates for this combination treatment, approved by the Food and Drug Administration in March 2017 for postmenopausal women with advanced breast cancer that is hormone receptor positive and HER2 negative, could also do just as well on an aromatase inhibitor alone, said Dr. Bedard, of the Princess Margaret Cancer Centre in Toronto.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

[email protected]

On Twitter @mitchelzoler

Correction, 5/6/17: An earlier version of this article misstated the citation.

LAS VEGAS – In women with higher density (HD) breasts, preoperative MRI revealed more abnormalities than were seen in women with lower density (LD) breasts, but there was no difference in the number of secondary cancers detected or long-term recurrence rates.

Breast density is often cited by radiologists as a reason to conduct a preoperative MRI, but the study suggests that it should not be a driving factor. “It’s a real challenge when our radiologists provide us reports that say, ‘Due to increased density, we recommend MRI,’ because it’s really hard to then disregard that. I think this is very important data,” said Judy Boughey, MD, professor of surgery at the Mayo Clinic, Rochester, MN, who moderated the session at the annual meeting of the American Society of Breast Surgeons where the research was presented.

“MRI is a valuable tool, and we’re still trying to figure out who it should be performed in,” said lead author Sarah McLaughlin, MD, of the Mayo Clinic, Jacksonville, FL, in an interview.

The researchers retrospectively analyzed data from 683 women at their institution who underwent preoperative MRI between 2007 and 2011. They grouped them by mammography results into LD (33%; Breast Imaging–Reporting and Data System density, 1 and 2) and HD (67%; BI-RADS density, 3 and 4).

Patients in the HD group more often had ipsilateral MRI findings (42% vs. 31%; P = .005), but ,of those with MRI findings, a similar number of patients in each group needed a second site biopsy (HD 65% vs. LD 67%; P = .78).

In all patients who had an additional MRI finding, the odds of detecting an additional ipsilateral cancer were not statistically significant between HD (32%) and LD (23%; P = .15) patients.

HD patients were also more likely to have abnormalities in the contralateral breast (25% vs. 14%; P = .009), but there were no statistically significant differences in rates of second-site biopsy recommendations or in the percentages of abnormalities that turned out to be cancerous (HD 6% vs. LD 3%; P = 1.0).

Following MRI, 70% of LD patients expressed a preference for breast-conserving surgery, compared with 53% of HD patients (P = .0001).

Over a median 7 years of follow-up, there was no difference in freedom from recurrence rates between the two groups (91% in LD vs. 90% in HD; P = .57).

“To me, it says that you don’t have to order an MRI just because they have cancer in a high density breast. You can feel reassured by your surgical plan and treatment recommendations based on conventional imaging,” said Dr. McLaughlin.

The researchers can’t determine if having an MRI done increased patient worry and potentially led to the higher rate of mastectomies chosen by women in the HD group. “Is that a result of the MRI? I don’t think we can say that, but there’s this whole other discussion piece that goes into it. You definitely see patients who say, ‘But it found these other things, and I’m going to have a mastectomy.’ So, there’s that patient preference and worry piece,” said Dr. McLaughlin.

The study results should offer some reassurance to patients. “There were no differences in local recurrence rates according to density. Maybe the next angle is allaying some of that fear, because the outcomes were the same. It’s really driven more by tumor biology and multimodality therapy,” said Dr. McLaughlin.

The study doesn’t provide the final word on breast density and MRI, according to Dr. Boughey. “I think this is an area that needs to be studied more with a clinical trial. There are several going on in different countries, and this is an area where we need level 1 data. This study does fit with what many other studies have shown, which is that MRI probably doesn’t have as much benefit as patients believe it does, so our role really is to try to help educate patients.”

LAS VEGAS – In women with higher density (HD) breasts, preoperative MRI revealed more abnormalities than were seen in women with lower density (LD) breasts, but there was no difference in the number of secondary cancers detected or long-term recurrence rates.

Breast density is often cited by radiologists as a reason to conduct a preoperative MRI, but the study suggests that it should not be a driving factor. “It’s a real challenge when our radiologists provide us reports that say, ‘Due to increased density, we recommend MRI,’ because it’s really hard to then disregard that. I think this is very important data,” said Judy Boughey, MD, professor of surgery at the Mayo Clinic, Rochester, MN, who moderated the session at the annual meeting of the American Society of Breast Surgeons where the research was presented.

“MRI is a valuable tool, and we’re still trying to figure out who it should be performed in,” said lead author Sarah McLaughlin, MD, of the Mayo Clinic, Jacksonville, FL, in an interview.

The researchers retrospectively analyzed data from 683 women at their institution who underwent preoperative MRI between 2007 and 2011. They grouped them by mammography results into LD (33%; Breast Imaging–Reporting and Data System density, 1 and 2) and HD (67%; BI-RADS density, 3 and 4).

Patients in the HD group more often had ipsilateral MRI findings (42% vs. 31%; P = .005), but ,of those with MRI findings, a similar number of patients in each group needed a second site biopsy (HD 65% vs. LD 67%; P = .78).

In all patients who had an additional MRI finding, the odds of detecting an additional ipsilateral cancer were not statistically significant between HD (32%) and LD (23%; P = .15) patients.

HD patients were also more likely to have abnormalities in the contralateral breast (25% vs. 14%; P = .009), but there were no statistically significant differences in rates of second-site biopsy recommendations or in the percentages of abnormalities that turned out to be cancerous (HD 6% vs. LD 3%; P = 1.0).

Following MRI, 70% of LD patients expressed a preference for breast-conserving surgery, compared with 53% of HD patients (P = .0001).

Over a median 7 years of follow-up, there was no difference in freedom from recurrence rates between the two groups (91% in LD vs. 90% in HD; P = .57).

“To me, it says that you don’t have to order an MRI just because they have cancer in a high density breast. You can feel reassured by your surgical plan and treatment recommendations based on conventional imaging,” said Dr. McLaughlin.

The researchers can’t determine if having an MRI done increased patient worry and potentially led to the higher rate of mastectomies chosen by women in the HD group. “Is that a result of the MRI? I don’t think we can say that, but there’s this whole other discussion piece that goes into it. You definitely see patients who say, ‘But it found these other things, and I’m going to have a mastectomy.’ So, there’s that patient preference and worry piece,” said Dr. McLaughlin.

The study results should offer some reassurance to patients. “There were no differences in local recurrence rates according to density. Maybe the next angle is allaying some of that fear, because the outcomes were the same. It’s really driven more by tumor biology and multimodality therapy,” said Dr. McLaughlin.

The study doesn’t provide the final word on breast density and MRI, according to Dr. Boughey. “I think this is an area that needs to be studied more with a clinical trial. There are several going on in different countries, and this is an area where we need level 1 data. This study does fit with what many other studies have shown, which is that MRI probably doesn’t have as much benefit as patients believe it does, so our role really is to try to help educate patients.”

LAS VEGAS – In women with higher density (HD) breasts, preoperative MRI revealed more abnormalities than were seen in women with lower density (LD) breasts, but there was no difference in the number of secondary cancers detected or long-term recurrence rates.

Breast density is often cited by radiologists as a reason to conduct a preoperative MRI, but the study suggests that it should not be a driving factor. “It’s a real challenge when our radiologists provide us reports that say, ‘Due to increased density, we recommend MRI,’ because it’s really hard to then disregard that. I think this is very important data,” said Judy Boughey, MD, professor of surgery at the Mayo Clinic, Rochester, MN, who moderated the session at the annual meeting of the American Society of Breast Surgeons where the research was presented.

“MRI is a valuable tool, and we’re still trying to figure out who it should be performed in,” said lead author Sarah McLaughlin, MD, of the Mayo Clinic, Jacksonville, FL, in an interview.

The researchers retrospectively analyzed data from 683 women at their institution who underwent preoperative MRI between 2007 and 2011. They grouped them by mammography results into LD (33%; Breast Imaging–Reporting and Data System density, 1 and 2) and HD (67%; BI-RADS density, 3 and 4).

Patients in the HD group more often had ipsilateral MRI findings (42% vs. 31%; P = .005), but ,of those with MRI findings, a similar number of patients in each group needed a second site biopsy (HD 65% vs. LD 67%; P = .78).

In all patients who had an additional MRI finding, the odds of detecting an additional ipsilateral cancer were not statistically significant between HD (32%) and LD (23%; P = .15) patients.

HD patients were also more likely to have abnormalities in the contralateral breast (25% vs. 14%; P = .009), but there were no statistically significant differences in rates of second-site biopsy recommendations or in the percentages of abnormalities that turned out to be cancerous (HD 6% vs. LD 3%; P = 1.0).

Following MRI, 70% of LD patients expressed a preference for breast-conserving surgery, compared with 53% of HD patients (P = .0001).

Over a median 7 years of follow-up, there was no difference in freedom from recurrence rates between the two groups (91% in LD vs. 90% in HD; P = .57).

“To me, it says that you don’t have to order an MRI just because they have cancer in a high density breast. You can feel reassured by your surgical plan and treatment recommendations based on conventional imaging,” said Dr. McLaughlin.

The researchers can’t determine if having an MRI done increased patient worry and potentially led to the higher rate of mastectomies chosen by women in the HD group. “Is that a result of the MRI? I don’t think we can say that, but there’s this whole other discussion piece that goes into it. You definitely see patients who say, ‘But it found these other things, and I’m going to have a mastectomy.’ So, there’s that patient preference and worry piece,” said Dr. McLaughlin.

The study results should offer some reassurance to patients. “There were no differences in local recurrence rates according to density. Maybe the next angle is allaying some of that fear, because the outcomes were the same. It’s really driven more by tumor biology and multimodality therapy,” said Dr. McLaughlin.

The study doesn’t provide the final word on breast density and MRI, according to Dr. Boughey. “I think this is an area that needs to be studied more with a clinical trial. There are several going on in different countries, and this is an area where we need level 1 data. This study does fit with what many other studies have shown, which is that MRI probably doesn’t have as much benefit as patients believe it does, so our role really is to try to help educate patients.”

LAS VEGAS – Overall survival was better when women with occult breast cancer had axillary lymph node dissection and radiation, instead of mastectomy, in a database review of 934 cases by the University of Maryland Medical Center, Baltimore, the largest review to date of how best to handle the problem.

Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation, according to an analysis of the National Cancer Database from 2004-2013. The results were presented at the annual meeting of the American Society of Breast Surgeons.

ALND plus radiation was independently associated with overall survival on multivariate analysis (HR 0.51, 95% CI 0.32-0.81, P = .004), and was associated with fewer comorbidities, use of chemotherapy, number of positive nodes, and number of nodes examined, compared with mastectomy.

Women treated with ALND plus radiation “had significantly better overall survival than those treated with mastectomy, even after adjusting for other covariates. We believe the study supports overall use of this treatment approach in patients with occult breast cancer,” said lead investigator, Lindsay Hessler, MD, of University of Maryland, Baltimore.

[email protected]

LAS VEGAS – Overall survival was better when women with occult breast cancer had axillary lymph node dissection and radiation, instead of mastectomy, in a database review of 934 cases by the University of Maryland Medical Center, Baltimore, the largest review to date of how best to handle the problem.

Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation, according to an analysis of the National Cancer Database from 2004-2013. The results were presented at the annual meeting of the American Society of Breast Surgeons.

ALND plus radiation was independently associated with overall survival on multivariate analysis (HR 0.51, 95% CI 0.32-0.81, P = .004), and was associated with fewer comorbidities, use of chemotherapy, number of positive nodes, and number of nodes examined, compared with mastectomy.

Women treated with ALND plus radiation “had significantly better overall survival than those treated with mastectomy, even after adjusting for other covariates. We believe the study supports overall use of this treatment approach in patients with occult breast cancer,” said lead investigator, Lindsay Hessler, MD, of University of Maryland, Baltimore.

[email protected]

LAS VEGAS – Overall survival was better when women with occult breast cancer had axillary lymph node dissection and radiation, instead of mastectomy, in a database review of 934 cases by the University of Maryland Medical Center, Baltimore, the largest review to date of how best to handle the problem.

Five- and 10-year overall survival was 90.8% and 84.8%, respectively, among the 342 women treated with axillary lymph node dissection (ALND) plus adjuvant radiation, versus 80.0% and 69.8% among the 592 who had ALND and mastectomies, plus or minus radiation, according to an analysis of the National Cancer Database from 2004-2013. The results were presented at the annual meeting of the American Society of Breast Surgeons.

ALND plus radiation was independently associated with overall survival on multivariate analysis (HR 0.51, 95% CI 0.32-0.81, P = .004), and was associated with fewer comorbidities, use of chemotherapy, number of positive nodes, and number of nodes examined, compared with mastectomy.

Women treated with ALND plus radiation “had significantly better overall survival than those treated with mastectomy, even after adjusting for other covariates. We believe the study supports overall use of this treatment approach in patients with occult breast cancer,” said lead investigator, Lindsay Hessler, MD, of University of Maryland, Baltimore.

[email protected]