LAKE BUENA VISTA, FLA. – Mortality related to prescription opioids is still climbing nationwide but not in centers or regions where there has been widespread implementation of guidelines for appropriate use, according to an expert involved in implementing guidelines in Washington state.

“If you follow guidelines for use of opioids, you can do what we did in Washington state and change the direction of those mortality curves,” reported David J. Tauben, MD, chief of pain medicine at the University of Washington, Seattle.

In data presented at the meeting, Dr. Tauben showed that the steep increase in opioid-related deaths and hospitalizations dating back to 1997 plateaued in Washington soon after the guidelines were implemented in 2007 and have followed a steep downward trajectory through the last year of follow-up in 2014.

Those data contrast starkly with nationwide figures updated June 21, 2016, on the Centers for Disease Control and Prevention website. In those figures, which also track data through 2014, the rates of deaths tied to drug overdose overall and to related to prescription opioids specifically have continued to climb. On the CDC website, which states that deaths related to prescription opioids have quadrupled since 1999, it was noted that more patients died from drug overdoses in 2014 than in any previous year. Prescriptions opioids were characterized as the “driving force” of this ongoing epidemic.

Washington state’s guidelines were created by the State Agency Medical Directors’ Group. But Dr. Tauben said that the principles of appropriate use of prescription opioids are well established and most recently were described in the CDC’s March 15, 2016, Morbidity and Mortality Weekly Report (MMWR). He suggested that adherence to these recommendations, which guide who to treat, how to treat, and how to assess for those most at risk for complications from opioids, can be expected to produce the same result.

Not least important, clinicians can keep the risk of overdose low by keeping doses low. Collating data from several studies, Dr. Tauben showed that the risk of overdose remains modest at opioid equivalent doses of 20 mg to about 50 mg per day. Graphically, the daily 50-mg equivalent was characterized as “the point of deflection where patients get in trouble.” In three of four published studies, the rise of rates in overdose was precipitous at about this point.

Keeping patients at a daily dose of 50 mg or below is further supported by the fact that “there is no evidence that a higher dose provides any additional benefit,” Dr. Tauben said. He also cited a study showing that patients at higher doses are more likely to have psychiatric comorbidity that complicates the pain complaint and may be better treated by alternative strategies.

At the University of Washington, chronic pain now is addressed routinely with a collaborative team approach that not only includes pain specialists but nursing care coordinators, pharmacists, physical therapists, and others, Dr. Tauben said. He considers increased physical activity, one of the goals in a collaborative multidisciplinary approach to chronic pain, a “miracle cure,” but acknowledged that designing comprehensive treatment that includes such strategies takes time and, at least initially, increases costs. However, he believes there is a clear return on investment.

“The evidence shows that effective control of chronic pain ultimately reduces costs,” Dr. Tauben said. Citing several studies, Dr. Tauben explained that chronic pain patients are major consumers of health care services and that consumption diminishes markedly when pain is controlled. He believes that most institutions would adopt and fund multidisciplinary pain care if fully informed of the cost benefits.

Although he acknowledged that many clinicians consider chronic pain patients challenging, Dr. Tauben said comprehensive pain management strategies are effective in most patients. After many years in general practice, Dr. Tauben switched to a focus on chronic pain because of the large unmet need and the success that can be achieved when a multidisciplinary treatment approach is applied.

“I became a pain specialist because it was the most satisfying part of my career,” Dr. Tauben reported.

To see the June 21 CDC data on opioid overdose, visit http//www.cdc.gov/drugoverdose/date/overdose.html. The March 15 MMWR report on the CDC guideline for prescribing opioids for chronic pain can be found at www.cdc.gov/mmwr/volumes/65/rr/6501e1.htm.

The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company. Dr. Tauben reported no potential financial conflicts of interest.

LAKE BUENA VISTA, FLA. – Mortality related to prescription opioids is still climbing nationwide but not in centers or regions where there has been widespread implementation of guidelines for appropriate use, according to an expert involved in implementing guidelines in Washington state.

“If you follow guidelines for use of opioids, you can do what we did in Washington state and change the direction of those mortality curves,” reported David J. Tauben, MD, chief of pain medicine at the University of Washington, Seattle.

In data presented at the meeting, Dr. Tauben showed that the steep increase in opioid-related deaths and hospitalizations dating back to 1997 plateaued in Washington soon after the guidelines were implemented in 2007 and have followed a steep downward trajectory through the last year of follow-up in 2014.

Those data contrast starkly with nationwide figures updated June 21, 2016, on the Centers for Disease Control and Prevention website. In those figures, which also track data through 2014, the rates of deaths tied to drug overdose overall and to related to prescription opioids specifically have continued to climb. On the CDC website, which states that deaths related to prescription opioids have quadrupled since 1999, it was noted that more patients died from drug overdoses in 2014 than in any previous year. Prescriptions opioids were characterized as the “driving force” of this ongoing epidemic.

Washington state’s guidelines were created by the State Agency Medical Directors’ Group. But Dr. Tauben said that the principles of appropriate use of prescription opioids are well established and most recently were described in the CDC’s March 15, 2016, Morbidity and Mortality Weekly Report (MMWR). He suggested that adherence to these recommendations, which guide who to treat, how to treat, and how to assess for those most at risk for complications from opioids, can be expected to produce the same result.

Not least important, clinicians can keep the risk of overdose low by keeping doses low. Collating data from several studies, Dr. Tauben showed that the risk of overdose remains modest at opioid equivalent doses of 20 mg to about 50 mg per day. Graphically, the daily 50-mg equivalent was characterized as “the point of deflection where patients get in trouble.” In three of four published studies, the rise of rates in overdose was precipitous at about this point.

Keeping patients at a daily dose of 50 mg or below is further supported by the fact that “there is no evidence that a higher dose provides any additional benefit,” Dr. Tauben said. He also cited a study showing that patients at higher doses are more likely to have psychiatric comorbidity that complicates the pain complaint and may be better treated by alternative strategies.

At the University of Washington, chronic pain now is addressed routinely with a collaborative team approach that not only includes pain specialists but nursing care coordinators, pharmacists, physical therapists, and others, Dr. Tauben said. He considers increased physical activity, one of the goals in a collaborative multidisciplinary approach to chronic pain, a “miracle cure,” but acknowledged that designing comprehensive treatment that includes such strategies takes time and, at least initially, increases costs. However, he believes there is a clear return on investment.

“The evidence shows that effective control of chronic pain ultimately reduces costs,” Dr. Tauben said. Citing several studies, Dr. Tauben explained that chronic pain patients are major consumers of health care services and that consumption diminishes markedly when pain is controlled. He believes that most institutions would adopt and fund multidisciplinary pain care if fully informed of the cost benefits.

Although he acknowledged that many clinicians consider chronic pain patients challenging, Dr. Tauben said comprehensive pain management strategies are effective in most patients. After many years in general practice, Dr. Tauben switched to a focus on chronic pain because of the large unmet need and the success that can be achieved when a multidisciplinary treatment approach is applied.

“I became a pain specialist because it was the most satisfying part of my career,” Dr. Tauben reported.

To see the June 21 CDC data on opioid overdose, visit http//www.cdc.gov/drugoverdose/date/overdose.html. The March 15 MMWR report on the CDC guideline for prescribing opioids for chronic pain can be found at www.cdc.gov/mmwr/volumes/65/rr/6501e1.htm.

The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company. Dr. Tauben reported no potential financial conflicts of interest.

LAKE BUENA VISTA, FLA. – Mortality related to prescription opioids is still climbing nationwide but not in centers or regions where there has been widespread implementation of guidelines for appropriate use, according to an expert involved in implementing guidelines in Washington state.

“If you follow guidelines for use of opioids, you can do what we did in Washington state and change the direction of those mortality curves,” reported David J. Tauben, MD, chief of pain medicine at the University of Washington, Seattle.

In data presented at the meeting, Dr. Tauben showed that the steep increase in opioid-related deaths and hospitalizations dating back to 1997 plateaued in Washington soon after the guidelines were implemented in 2007 and have followed a steep downward trajectory through the last year of follow-up in 2014.

Those data contrast starkly with nationwide figures updated June 21, 2016, on the Centers for Disease Control and Prevention website. In those figures, which also track data through 2014, the rates of deaths tied to drug overdose overall and to related to prescription opioids specifically have continued to climb. On the CDC website, which states that deaths related to prescription opioids have quadrupled since 1999, it was noted that more patients died from drug overdoses in 2014 than in any previous year. Prescriptions opioids were characterized as the “driving force” of this ongoing epidemic.

Washington state’s guidelines were created by the State Agency Medical Directors’ Group. But Dr. Tauben said that the principles of appropriate use of prescription opioids are well established and most recently were described in the CDC’s March 15, 2016, Morbidity and Mortality Weekly Report (MMWR). He suggested that adherence to these recommendations, which guide who to treat, how to treat, and how to assess for those most at risk for complications from opioids, can be expected to produce the same result.

Not least important, clinicians can keep the risk of overdose low by keeping doses low. Collating data from several studies, Dr. Tauben showed that the risk of overdose remains modest at opioid equivalent doses of 20 mg to about 50 mg per day. Graphically, the daily 50-mg equivalent was characterized as “the point of deflection where patients get in trouble.” In three of four published studies, the rise of rates in overdose was precipitous at about this point.

Keeping patients at a daily dose of 50 mg or below is further supported by the fact that “there is no evidence that a higher dose provides any additional benefit,” Dr. Tauben said. He also cited a study showing that patients at higher doses are more likely to have psychiatric comorbidity that complicates the pain complaint and may be better treated by alternative strategies.

At the University of Washington, chronic pain now is addressed routinely with a collaborative team approach that not only includes pain specialists but nursing care coordinators, pharmacists, physical therapists, and others, Dr. Tauben said. He considers increased physical activity, one of the goals in a collaborative multidisciplinary approach to chronic pain, a “miracle cure,” but acknowledged that designing comprehensive treatment that includes such strategies takes time and, at least initially, increases costs. However, he believes there is a clear return on investment.

“The evidence shows that effective control of chronic pain ultimately reduces costs,” Dr. Tauben said. Citing several studies, Dr. Tauben explained that chronic pain patients are major consumers of health care services and that consumption diminishes markedly when pain is controlled. He believes that most institutions would adopt and fund multidisciplinary pain care if fully informed of the cost benefits.

Although he acknowledged that many clinicians consider chronic pain patients challenging, Dr. Tauben said comprehensive pain management strategies are effective in most patients. After many years in general practice, Dr. Tauben switched to a focus on chronic pain because of the large unmet need and the success that can be achieved when a multidisciplinary treatment approach is applied.

“I became a pain specialist because it was the most satisfying part of my career,” Dr. Tauben reported.

To see the June 21 CDC data on opioid overdose, visit http//www.cdc.gov/drugoverdose/date/overdose.html. The March 15 MMWR report on the CDC guideline for prescribing opioids for chronic pain can be found at www.cdc.gov/mmwr/volumes/65/rr/6501e1.htm.

The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company. Dr. Tauben reported no potential financial conflicts of interest.

BOSTON – Surgery is the standard of care for most skin cancers, but nonsurgical and adjuvant treatments can be good options for certain skin cancers when surgery would be neither curative nor feasible, according to Anthony Rossi, MD.

“Whether you’re treating a superficial basal cell or superficial squamous cell carcinoma, I think first and foremost, if you’re going to use nonsurgical treatment options, it’s important to have a good biopsy diagnosis,” Dr. Rossi said at the American Academy of Dermatology summer meeting. He also advised that the biopsy capture the entire lesion or a good portion of it to get a good representation. “You don’t want to be surprised by any hiding, high-risk subtypes,” said Dr. Rossi, of the Memorial Sloan Kettering Cancer Center in New York.

Deciding on a nonsurgical treatment option should be based on knowing the patient. For example, know the patient’s concerns about cosmetic deformities, willingness to undergo surgery or not, and ability and willingness to do follow-up self-care.

For superficial basal cell or squamous cell carcinomas in situ and even lentigo maligna in situ not amenable to surgery, imiquimod may be an appropriate treatment. Dr. Rossi said his practice is to use it in an incremental fashion, starting with application five times per week, going to every day if there is no response after 1 to 2 weeks. If the response remains inadequate, he recommended adding a topical retinoid, such as tazarotene, in an effort to increase penetration.

For basal cell carcinomas and squamous cell carcinoma in situ, he uses imiquimod for a total of 6 to 8 weeks, starting from the time of the first reaction. For melanoma in situ, he uses it for more than 60 applications (12 weeks).

To show patients where they should be applying any topical treatment, Dr. Rossi marks the skin, photographs it, and prints out a picture for the patient. Sometimes he uses the patient’s phone to take the picture. For a basal cell or squamous cell carcinoma in situ, he indicates an area at least 5 to 10 mm beyond the margin of the tumor. The area is even larger for melanomas.

Dr. Rossi studies confocal microscopy to detect skin cancers. He uses it before treating a lesion to define the clinical boundaries of the lesion and the boundaries for the nonsurgical treatments, and then he uses it on follow up to look for any recurrences.

New anti-tumor agents

Two oral inhibitors of the sonic hedgehog pathway have been approved within the past 5 years for locally advanced or metastatic basal cell carcinomas. “In the right person, they can be quite beneficial if surgery would leave them with a very large cosmetic deformity or if surgery would be not curative,” Dr. Rossi said. “We’re seeing good results” with acceptable adverse events, specifically taste disturbances, muscle cramps, and hair loss. The first such drug, vismodegib (Erivedge), was approved in 2012, and sonidegib (Odomzo) came on the market about 1 year ago.

Besides oral agents, photodynamic therapy (PDT) with photosensitizers are another option for certain skin tumors. Dr. Rossi said his practice is to keep the treatment room fairly warm to assure good blood flow to the skin and thus good penetration of the drug. Because PDT acts by generating singlet oxygen to kill tumors, good blood flow to the tumor is necessary. To minimize discomfort, he uses pretreatment acetaminophen if patients can take it. After a skin reaction occurs, cool compresses are used, along with dilute acetic acid soaks on crusted or scaling lesions in an effort to prevent infection.

And while these treatments can produce quite angry-looking lesions in the short term, very good healing usually occurs if patients are diligent about wound care. However, Dr. Rossi cautioned that they may need “more hand holding with these nonsurgical treatments, because it is a longer duration of treatment.”

In general for counseling patients on nonsurgical treatments, Dr. Rossi said it is advisable to have good pretreatment and post-treatment plans. “They have to know that they will need to be following up to make sure that there is no recurrence,” he said. “We don’t have clear surgical margins if we’re using these topical treatments, so we have to make sure that they have good, constant follow-up.”

Dr. Rossi reported consulting relationships with Merz, DynaMed, and Novartis.

BOSTON – Surgery is the standard of care for most skin cancers, but nonsurgical and adjuvant treatments can be good options for certain skin cancers when surgery would be neither curative nor feasible, according to Anthony Rossi, MD.

“Whether you’re treating a superficial basal cell or superficial squamous cell carcinoma, I think first and foremost, if you’re going to use nonsurgical treatment options, it’s important to have a good biopsy diagnosis,” Dr. Rossi said at the American Academy of Dermatology summer meeting. He also advised that the biopsy capture the entire lesion or a good portion of it to get a good representation. “You don’t want to be surprised by any hiding, high-risk subtypes,” said Dr. Rossi, of the Memorial Sloan Kettering Cancer Center in New York.

Deciding on a nonsurgical treatment option should be based on knowing the patient. For example, know the patient’s concerns about cosmetic deformities, willingness to undergo surgery or not, and ability and willingness to do follow-up self-care.

For superficial basal cell or squamous cell carcinomas in situ and even lentigo maligna in situ not amenable to surgery, imiquimod may be an appropriate treatment. Dr. Rossi said his practice is to use it in an incremental fashion, starting with application five times per week, going to every day if there is no response after 1 to 2 weeks. If the response remains inadequate, he recommended adding a topical retinoid, such as tazarotene, in an effort to increase penetration.

For basal cell carcinomas and squamous cell carcinoma in situ, he uses imiquimod for a total of 6 to 8 weeks, starting from the time of the first reaction. For melanoma in situ, he uses it for more than 60 applications (12 weeks).

To show patients where they should be applying any topical treatment, Dr. Rossi marks the skin, photographs it, and prints out a picture for the patient. Sometimes he uses the patient’s phone to take the picture. For a basal cell or squamous cell carcinoma in situ, he indicates an area at least 5 to 10 mm beyond the margin of the tumor. The area is even larger for melanomas.

Dr. Rossi studies confocal microscopy to detect skin cancers. He uses it before treating a lesion to define the clinical boundaries of the lesion and the boundaries for the nonsurgical treatments, and then he uses it on follow up to look for any recurrences.

New anti-tumor agents

Two oral inhibitors of the sonic hedgehog pathway have been approved within the past 5 years for locally advanced or metastatic basal cell carcinomas. “In the right person, they can be quite beneficial if surgery would leave them with a very large cosmetic deformity or if surgery would be not curative,” Dr. Rossi said. “We’re seeing good results” with acceptable adverse events, specifically taste disturbances, muscle cramps, and hair loss. The first such drug, vismodegib (Erivedge), was approved in 2012, and sonidegib (Odomzo) came on the market about 1 year ago.

Besides oral agents, photodynamic therapy (PDT) with photosensitizers are another option for certain skin tumors. Dr. Rossi said his practice is to keep the treatment room fairly warm to assure good blood flow to the skin and thus good penetration of the drug. Because PDT acts by generating singlet oxygen to kill tumors, good blood flow to the tumor is necessary. To minimize discomfort, he uses pretreatment acetaminophen if patients can take it. After a skin reaction occurs, cool compresses are used, along with dilute acetic acid soaks on crusted or scaling lesions in an effort to prevent infection.

And while these treatments can produce quite angry-looking lesions in the short term, very good healing usually occurs if patients are diligent about wound care. However, Dr. Rossi cautioned that they may need “more hand holding with these nonsurgical treatments, because it is a longer duration of treatment.”

In general for counseling patients on nonsurgical treatments, Dr. Rossi said it is advisable to have good pretreatment and post-treatment plans. “They have to know that they will need to be following up to make sure that there is no recurrence,” he said. “We don’t have clear surgical margins if we’re using these topical treatments, so we have to make sure that they have good, constant follow-up.”

Dr. Rossi reported consulting relationships with Merz, DynaMed, and Novartis.

BOSTON – Surgery is the standard of care for most skin cancers, but nonsurgical and adjuvant treatments can be good options for certain skin cancers when surgery would be neither curative nor feasible, according to Anthony Rossi, MD.

“Whether you’re treating a superficial basal cell or superficial squamous cell carcinoma, I think first and foremost, if you’re going to use nonsurgical treatment options, it’s important to have a good biopsy diagnosis,” Dr. Rossi said at the American Academy of Dermatology summer meeting. He also advised that the biopsy capture the entire lesion or a good portion of it to get a good representation. “You don’t want to be surprised by any hiding, high-risk subtypes,” said Dr. Rossi, of the Memorial Sloan Kettering Cancer Center in New York.

Deciding on a nonsurgical treatment option should be based on knowing the patient. For example, know the patient’s concerns about cosmetic deformities, willingness to undergo surgery or not, and ability and willingness to do follow-up self-care.

For superficial basal cell or squamous cell carcinomas in situ and even lentigo maligna in situ not amenable to surgery, imiquimod may be an appropriate treatment. Dr. Rossi said his practice is to use it in an incremental fashion, starting with application five times per week, going to every day if there is no response after 1 to 2 weeks. If the response remains inadequate, he recommended adding a topical retinoid, such as tazarotene, in an effort to increase penetration.

For basal cell carcinomas and squamous cell carcinoma in situ, he uses imiquimod for a total of 6 to 8 weeks, starting from the time of the first reaction. For melanoma in situ, he uses it for more than 60 applications (12 weeks).

To show patients where they should be applying any topical treatment, Dr. Rossi marks the skin, photographs it, and prints out a picture for the patient. Sometimes he uses the patient’s phone to take the picture. For a basal cell or squamous cell carcinoma in situ, he indicates an area at least 5 to 10 mm beyond the margin of the tumor. The area is even larger for melanomas.

Dr. Rossi studies confocal microscopy to detect skin cancers. He uses it before treating a lesion to define the clinical boundaries of the lesion and the boundaries for the nonsurgical treatments, and then he uses it on follow up to look for any recurrences.

New anti-tumor agents

Two oral inhibitors of the sonic hedgehog pathway have been approved within the past 5 years for locally advanced or metastatic basal cell carcinomas. “In the right person, they can be quite beneficial if surgery would leave them with a very large cosmetic deformity or if surgery would be not curative,” Dr. Rossi said. “We’re seeing good results” with acceptable adverse events, specifically taste disturbances, muscle cramps, and hair loss. The first such drug, vismodegib (Erivedge), was approved in 2012, and sonidegib (Odomzo) came on the market about 1 year ago.

Besides oral agents, photodynamic therapy (PDT) with photosensitizers are another option for certain skin tumors. Dr. Rossi said his practice is to keep the treatment room fairly warm to assure good blood flow to the skin and thus good penetration of the drug. Because PDT acts by generating singlet oxygen to kill tumors, good blood flow to the tumor is necessary. To minimize discomfort, he uses pretreatment acetaminophen if patients can take it. After a skin reaction occurs, cool compresses are used, along with dilute acetic acid soaks on crusted or scaling lesions in an effort to prevent infection.

And while these treatments can produce quite angry-looking lesions in the short term, very good healing usually occurs if patients are diligent about wound care. However, Dr. Rossi cautioned that they may need “more hand holding with these nonsurgical treatments, because it is a longer duration of treatment.”

In general for counseling patients on nonsurgical treatments, Dr. Rossi said it is advisable to have good pretreatment and post-treatment plans. “They have to know that they will need to be following up to make sure that there is no recurrence,” he said. “We don’t have clear surgical margins if we’re using these topical treatments, so we have to make sure that they have good, constant follow-up.”

Dr. Rossi reported consulting relationships with Merz, DynaMed, and Novartis.

BOSTON – Most ulcers seen in the clinic setting are venous, arterial, or neuropathic, but about 10% are tied to “more unusual causes” and require biopsy, according to Tania J. Phillips, MD.

A particular concern is malignancy, Dr. Phillips, professor of dermatology at Boston University, said at the American Academy of Dermatology summer meeting.

“We do need to have a low threshold for biopsying wounds – particularly if they are wounds of long duration and are not healing,”

A rule of thumb for performing biopsy is 3 months of non-healing, she said.

“If you have a non-healing wound and you’re doing good wound care, you have to re-evaluate. Do you have the right diagnosis? You may need several biopsies on several different occasions to get the right diagnosis,” she said.

Other reasons to biopsy include suspected infection – whether bacterial, fungal, or mycobacterial; atypical appearance; suspected vasculitis; and recent travel history.

Ideally, the biopsy will include a deep wedge containing wound margin and the wound bed.

“Failing that, [take] multiple punch biopsies from the wound bed and the margins,” she said.

While many people are nervous about biopsying an ulcer, most biopsy sites heal very well with no complications, she noted.

As for what to do with the tissue, it can be sent in formalin.

“But if you’re going to do immunofluorescence, you will need Michel’s medium. And if you want to culture, just check with your microbiology lab, because often they will take your piece of tissue and they’ll mix it up, and they’ll divide it and will send it out for bacterial, fungal, mycobacterial culture and you won’t have to do that yourself,” she said.

Dr. Phillips noted that she doesn’t usually suture an ulcer biopsy site.

“The skin around ulcers is usually very friable, the sutures often pull out, and you can usually just pack the biopsy site with gel foam or with an alginate, and then just apply firm compression like a wrap over the biopsy site and you’ll do just fine,” she said.

Dr. Phillips reported a financial relationship with Hygeia.

[email protected]

BOSTON – Most ulcers seen in the clinic setting are venous, arterial, or neuropathic, but about 10% are tied to “more unusual causes” and require biopsy, according to Tania J. Phillips, MD.

A particular concern is malignancy, Dr. Phillips, professor of dermatology at Boston University, said at the American Academy of Dermatology summer meeting.

“We do need to have a low threshold for biopsying wounds – particularly if they are wounds of long duration and are not healing,”

A rule of thumb for performing biopsy is 3 months of non-healing, she said.

“If you have a non-healing wound and you’re doing good wound care, you have to re-evaluate. Do you have the right diagnosis? You may need several biopsies on several different occasions to get the right diagnosis,” she said.

Other reasons to biopsy include suspected infection – whether bacterial, fungal, or mycobacterial; atypical appearance; suspected vasculitis; and recent travel history.

Ideally, the biopsy will include a deep wedge containing wound margin and the wound bed.

“Failing that, [take] multiple punch biopsies from the wound bed and the margins,” she said.

While many people are nervous about biopsying an ulcer, most biopsy sites heal very well with no complications, she noted.

As for what to do with the tissue, it can be sent in formalin.

“But if you’re going to do immunofluorescence, you will need Michel’s medium. And if you want to culture, just check with your microbiology lab, because often they will take your piece of tissue and they’ll mix it up, and they’ll divide it and will send it out for bacterial, fungal, mycobacterial culture and you won’t have to do that yourself,” she said.

Dr. Phillips noted that she doesn’t usually suture an ulcer biopsy site.

“The skin around ulcers is usually very friable, the sutures often pull out, and you can usually just pack the biopsy site with gel foam or with an alginate, and then just apply firm compression like a wrap over the biopsy site and you’ll do just fine,” she said.

Dr. Phillips reported a financial relationship with Hygeia.

[email protected]

BOSTON – Most ulcers seen in the clinic setting are venous, arterial, or neuropathic, but about 10% are tied to “more unusual causes” and require biopsy, according to Tania J. Phillips, MD.

A particular concern is malignancy, Dr. Phillips, professor of dermatology at Boston University, said at the American Academy of Dermatology summer meeting.

“We do need to have a low threshold for biopsying wounds – particularly if they are wounds of long duration and are not healing,”

A rule of thumb for performing biopsy is 3 months of non-healing, she said.

“If you have a non-healing wound and you’re doing good wound care, you have to re-evaluate. Do you have the right diagnosis? You may need several biopsies on several different occasions to get the right diagnosis,” she said.

Other reasons to biopsy include suspected infection – whether bacterial, fungal, or mycobacterial; atypical appearance; suspected vasculitis; and recent travel history.

Ideally, the biopsy will include a deep wedge containing wound margin and the wound bed.

“Failing that, [take] multiple punch biopsies from the wound bed and the margins,” she said.

While many people are nervous about biopsying an ulcer, most biopsy sites heal very well with no complications, she noted.

As for what to do with the tissue, it can be sent in formalin.

“But if you’re going to do immunofluorescence, you will need Michel’s medium. And if you want to culture, just check with your microbiology lab, because often they will take your piece of tissue and they’ll mix it up, and they’ll divide it and will send it out for bacterial, fungal, mycobacterial culture and you won’t have to do that yourself,” she said.

Dr. Phillips noted that she doesn’t usually suture an ulcer biopsy site.

“The skin around ulcers is usually very friable, the sutures often pull out, and you can usually just pack the biopsy site with gel foam or with an alginate, and then just apply firm compression like a wrap over the biopsy site and you’ll do just fine,” she said.

Dr. Phillips reported a financial relationship with Hygeia.

[email protected]

Very little evidence exists for how to avoid using seclusion and restraints when de-escalating aggression in psychiatric patients in acute care settings, a recent report from the Agency for Healthcare Research and Quality shows.

Historically, aggression in patients has been met with either involuntary placement of the patient in a secured area, or with the involuntary administration of some form of restraint, which might be mechanical, pharmacologic.

Since the late 1990s, however, the Centers for Medicare & Medicaid Services and the Joint Commission have required using seclusion and restraints only after less restrictive measures have failed. Nearly two decades since, those requirements have been universally in force. “Despite practice guidelines advocating limitations of the use of seclusion or restraints as much as possible,” the interventions are used for 10%-30% of patients admitted to acute psychiatric units in the United States and Europe, the authors wrote.

Yet, when reviewing strategies such as creating a calm environment, medication modifications, staffing changes, training programs, and peer-based interventions, only risk assessment had “any reasonable evidence” that it is an effective method for avoiding aggression in psychiatric patients in nonpsychiatric hospital settings compared with usual care, the investigators found.

“The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.”

The findings suggest that policymakers are at a disadvantage for measuring performance improvement of these kinds of facilities seeking to reduce their use of seclusion and restraint. The authors asked, “What is the role of quality measures, designed to create incentives to improve the quality of care, when the evidence base for those measures is unclear?”

For the review, patient aggression was defined as making specific imminent verbal threats, or using actual violence toward self, others, or property. The review spanned the literature published between January 1991 and February 2016, and focused on studies with adults having a diagnosed psychiatric disorder, including delirium, who received interventions targeting aggressive behavior in acute care settings. Studies of psychiatric hospitals were excluded, since such facilities often use multimodal strategies that are not suitable for acute care settings that do not care for long-term patients with chronic psychiatric diagnoses.

The studies reviewed had as their primary outcomes either or both data on decreased aggression in terms of frequency, severity, or duration; and a reduction in the use of seclusion and restraints. Ultimately, out of 1,921 potentially relevant citations, the investigators found a combined total of 11 randomized, controlled trials and cluster randomized trials that qualified for their evidence review, the authors wrote in the report’s executive summary.

Finding strong evidence for any one method of de-escalation was complicated by studies that did not adhere to strict use of cluster randomized trial protocols, or did not report precise correlations between specific, targeted interventions for patients actively exhibiting aggression. In addition, the interventions themselves often were described inexactly, or as a matrix of interventions, making them difficult to classify. The reviewers also complained in their report about the absence of data on treatment effect modifiers.

The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.” Evidence for how to de-escalate active aggression was “even more limited” according to the authors.

Until more evidence is gathered and reviewed, policymakers could find themselves wondering whether “implementation decisions [should] be delayed until more evidence becomes available,” they wrote.

The AHRQ’s Effective Health Care Program produced the report, titled “Strategies to de-escalate aggressive behavior in psychiatric patients.”

[email protected]

On Twitter @whitneymcknight

Very little evidence exists for how to avoid using seclusion and restraints when de-escalating aggression in psychiatric patients in acute care settings, a recent report from the Agency for Healthcare Research and Quality shows.

Historically, aggression in patients has been met with either involuntary placement of the patient in a secured area, or with the involuntary administration of some form of restraint, which might be mechanical, pharmacologic.

Since the late 1990s, however, the Centers for Medicare & Medicaid Services and the Joint Commission have required using seclusion and restraints only after less restrictive measures have failed. Nearly two decades since, those requirements have been universally in force. “Despite practice guidelines advocating limitations of the use of seclusion or restraints as much as possible,” the interventions are used for 10%-30% of patients admitted to acute psychiatric units in the United States and Europe, the authors wrote.

Yet, when reviewing strategies such as creating a calm environment, medication modifications, staffing changes, training programs, and peer-based interventions, only risk assessment had “any reasonable evidence” that it is an effective method for avoiding aggression in psychiatric patients in nonpsychiatric hospital settings compared with usual care, the investigators found.

“The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.”

The findings suggest that policymakers are at a disadvantage for measuring performance improvement of these kinds of facilities seeking to reduce their use of seclusion and restraint. The authors asked, “What is the role of quality measures, designed to create incentives to improve the quality of care, when the evidence base for those measures is unclear?”

For the review, patient aggression was defined as making specific imminent verbal threats, or using actual violence toward self, others, or property. The review spanned the literature published between January 1991 and February 2016, and focused on studies with adults having a diagnosed psychiatric disorder, including delirium, who received interventions targeting aggressive behavior in acute care settings. Studies of psychiatric hospitals were excluded, since such facilities often use multimodal strategies that are not suitable for acute care settings that do not care for long-term patients with chronic psychiatric diagnoses.

The studies reviewed had as their primary outcomes either or both data on decreased aggression in terms of frequency, severity, or duration; and a reduction in the use of seclusion and restraints. Ultimately, out of 1,921 potentially relevant citations, the investigators found a combined total of 11 randomized, controlled trials and cluster randomized trials that qualified for their evidence review, the authors wrote in the report’s executive summary.

Finding strong evidence for any one method of de-escalation was complicated by studies that did not adhere to strict use of cluster randomized trial protocols, or did not report precise correlations between specific, targeted interventions for patients actively exhibiting aggression. In addition, the interventions themselves often were described inexactly, or as a matrix of interventions, making them difficult to classify. The reviewers also complained in their report about the absence of data on treatment effect modifiers.

The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.” Evidence for how to de-escalate active aggression was “even more limited” according to the authors.

Until more evidence is gathered and reviewed, policymakers could find themselves wondering whether “implementation decisions [should] be delayed until more evidence becomes available,” they wrote.

The AHRQ’s Effective Health Care Program produced the report, titled “Strategies to de-escalate aggressive behavior in psychiatric patients.”

[email protected]

On Twitter @whitneymcknight

Very little evidence exists for how to avoid using seclusion and restraints when de-escalating aggression in psychiatric patients in acute care settings, a recent report from the Agency for Healthcare Research and Quality shows.

Historically, aggression in patients has been met with either involuntary placement of the patient in a secured area, or with the involuntary administration of some form of restraint, which might be mechanical, pharmacologic.

Since the late 1990s, however, the Centers for Medicare & Medicaid Services and the Joint Commission have required using seclusion and restraints only after less restrictive measures have failed. Nearly two decades since, those requirements have been universally in force. “Despite practice guidelines advocating limitations of the use of seclusion or restraints as much as possible,” the interventions are used for 10%-30% of patients admitted to acute psychiatric units in the United States and Europe, the authors wrote.

Yet, when reviewing strategies such as creating a calm environment, medication modifications, staffing changes, training programs, and peer-based interventions, only risk assessment had “any reasonable evidence” that it is an effective method for avoiding aggression in psychiatric patients in nonpsychiatric hospital settings compared with usual care, the investigators found.

“The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.”

The findings suggest that policymakers are at a disadvantage for measuring performance improvement of these kinds of facilities seeking to reduce their use of seclusion and restraint. The authors asked, “What is the role of quality measures, designed to create incentives to improve the quality of care, when the evidence base for those measures is unclear?”

For the review, patient aggression was defined as making specific imminent verbal threats, or using actual violence toward self, others, or property. The review spanned the literature published between January 1991 and February 2016, and focused on studies with adults having a diagnosed psychiatric disorder, including delirium, who received interventions targeting aggressive behavior in acute care settings. Studies of psychiatric hospitals were excluded, since such facilities often use multimodal strategies that are not suitable for acute care settings that do not care for long-term patients with chronic psychiatric diagnoses.

The studies reviewed had as their primary outcomes either or both data on decreased aggression in terms of frequency, severity, or duration; and a reduction in the use of seclusion and restraints. Ultimately, out of 1,921 potentially relevant citations, the investigators found a combined total of 11 randomized, controlled trials and cluster randomized trials that qualified for their evidence review, the authors wrote in the report’s executive summary.

Finding strong evidence for any one method of de-escalation was complicated by studies that did not adhere to strict use of cluster randomized trial protocols, or did not report precise correlations between specific, targeted interventions for patients actively exhibiting aggression. In addition, the interventions themselves often were described inexactly, or as a matrix of interventions, making them difficult to classify. The reviewers also complained in their report about the absence of data on treatment effect modifiers.

The current evidence base leaves clinicians, administrators, policymakers, and patients without clear guidance,” they wrote, noting that even the strength of the favorable evidence is “at best, low.” Evidence for how to de-escalate active aggression was “even more limited” according to the authors.

Until more evidence is gathered and reviewed, policymakers could find themselves wondering whether “implementation decisions [should] be delayed until more evidence becomes available,” they wrote.

The AHRQ’s Effective Health Care Program produced the report, titled “Strategies to de-escalate aggressive behavior in psychiatric patients.”

[email protected]

On Twitter @whitneymcknight

Aedes aegypti mosquito

Photo courtesy of

Muhammad Mahdi Karim

Officials have announced what is likely the first known occurrence of local mosquito-borne Zika virus transmission in the continental US.*

Fourteen cases of Zika virus in 2 Florida counties are believed to have been caused by bites of local Aedes aegypti mosquitoes.

The Florida Department of Health (DOH) believes that active transmission of the Zika virus is only occurring in a small area in Miami-Dade County.

The US Centers for Disease Control and Prevention (CDC) has recommended that women who are pregnant or thinking of becoming pregnant avoid unnecessary travel to the impacted area. The agency has also issued a guidance for people living in or traveling to the area.

“All the evidence we have seen indicates that this is mosquito-borne transmission that occurred several weeks ago in several blocks in Miami,” said Tom Frieden, MD, director of the CDC.

The exact location is within the boundaries of the following area: NW 5th Avenue to the west, US 1 to the east, NW/NE 38th Street to the north and NW/NE 20th Street to the south. This is about one square mile.

Protecting the blood supply

The US Food and Drug Administration (FDA) has requested that all blood centers in Miami-Dade and Broward counties stop collecting blood immediately.

Blood centers in these counties can resume blood collection once they begin testing each unit of blood with an available investigational donor screening test for Zika virus RNA or once they implement the use of an approved or investigational pathogen inactivation technology.

The FDA also recommended that blood centers in nearby counties implement the same precautions as soon as possible to help maintain the safety of the blood supply. The agency has encouraged screening of the blood supply in regions of the US at risk of local mosquito-borne Zika transmission.

The FDA said it is working with companies that are making blood screening tests available under an Investigational New Drug (IND) application to ensure these companies are ready to expand testing as needed. Blood collection centers may choose to participate in testing under an IND even in the absence of local mosquito-borne transmission of Zika virus.

Florida/CDC response

Florida state officials have implemented mosquito control measures and a community-wide search for additional Zika cases. Thus far, Florida’s DOH has conducted testing for the Zika virus in more than 2300 people statewide.

The DOH has activated the Joint Information Center within the State Emergency Operations Center to ensure the area impacted by local transmission of the Zika virus has coordinated access to information and resources.

The DOH has also begun the process of contracting with commercial pest control companies to enhance and expand mosquito mitigation and abatement, including increased spraying, in the impacted area.

Earlier this year, Florida’s governor, Rick Scott, directed the State Surgeon General to activate a Zika Virus Information Hotline for Florida residents and visitors. The number for this hotline is 1-855-622-6735.

The CDC said it is coordinating with Florida officials leading the ongoing investigation into local transmission of the Zika virus. At the state’s request, the CDC sent a medical epidemiologist to provide additional assistance.

Governor Scott has also asked the CDC to activate a CDC Emergency Response Team to assist the DOH and other partners in their investigation, sample collection, and mosquito control efforts.

To date, the CDC has provided Florida with more than $8 million in Zika-specific funding and about $27 million in emergency preparedness funding that can be used for Zika response efforts.

“We have been working with state and local governments to prepare for the likelihood of local mosquito-borne Zika virus transmission in the continental United States and Hawaii,” said Lyle Petersen, MD, incident manager for CDC’s Zika virus response.

“We anticipate that there may be additional cases of ‘homegrown’ Zika in the coming weeks. Our top priority is to protect pregnant women from the potentially devastating harm caused by Zika.”

For more information about the Zika virus, visit http://www.cdc.gov/zika/.

*This story was updated on August 1.

Aedes aegypti mosquito

Photo courtesy of

Muhammad Mahdi Karim

Officials have announced what is likely the first known occurrence of local mosquito-borne Zika virus transmission in the continental US.*

Fourteen cases of Zika virus in 2 Florida counties are believed to have been caused by bites of local Aedes aegypti mosquitoes.

The Florida Department of Health (DOH) believes that active transmission of the Zika virus is only occurring in a small area in Miami-Dade County.

The US Centers for Disease Control and Prevention (CDC) has recommended that women who are pregnant or thinking of becoming pregnant avoid unnecessary travel to the impacted area. The agency has also issued a guidance for people living in or traveling to the area.

“All the evidence we have seen indicates that this is mosquito-borne transmission that occurred several weeks ago in several blocks in Miami,” said Tom Frieden, MD, director of the CDC.

The exact location is within the boundaries of the following area: NW 5th Avenue to the west, US 1 to the east, NW/NE 38th Street to the north and NW/NE 20th Street to the south. This is about one square mile.

Protecting the blood supply

The US Food and Drug Administration (FDA) has requested that all blood centers in Miami-Dade and Broward counties stop collecting blood immediately.

Blood centers in these counties can resume blood collection once they begin testing each unit of blood with an available investigational donor screening test for Zika virus RNA or once they implement the use of an approved or investigational pathogen inactivation technology.

The FDA also recommended that blood centers in nearby counties implement the same precautions as soon as possible to help maintain the safety of the blood supply. The agency has encouraged screening of the blood supply in regions of the US at risk of local mosquito-borne Zika transmission.

The FDA said it is working with companies that are making blood screening tests available under an Investigational New Drug (IND) application to ensure these companies are ready to expand testing as needed. Blood collection centers may choose to participate in testing under an IND even in the absence of local mosquito-borne transmission of Zika virus.

Florida/CDC response

Florida state officials have implemented mosquito control measures and a community-wide search for additional Zika cases. Thus far, Florida’s DOH has conducted testing for the Zika virus in more than 2300 people statewide.

The DOH has activated the Joint Information Center within the State Emergency Operations Center to ensure the area impacted by local transmission of the Zika virus has coordinated access to information and resources.

The DOH has also begun the process of contracting with commercial pest control companies to enhance and expand mosquito mitigation and abatement, including increased spraying, in the impacted area.

Earlier this year, Florida’s governor, Rick Scott, directed the State Surgeon General to activate a Zika Virus Information Hotline for Florida residents and visitors. The number for this hotline is 1-855-622-6735.

The CDC said it is coordinating with Florida officials leading the ongoing investigation into local transmission of the Zika virus. At the state’s request, the CDC sent a medical epidemiologist to provide additional assistance.

Governor Scott has also asked the CDC to activate a CDC Emergency Response Team to assist the DOH and other partners in their investigation, sample collection, and mosquito control efforts.

To date, the CDC has provided Florida with more than $8 million in Zika-specific funding and about $27 million in emergency preparedness funding that can be used for Zika response efforts.

“We have been working with state and local governments to prepare for the likelihood of local mosquito-borne Zika virus transmission in the continental United States and Hawaii,” said Lyle Petersen, MD, incident manager for CDC’s Zika virus response.

“We anticipate that there may be additional cases of ‘homegrown’ Zika in the coming weeks. Our top priority is to protect pregnant women from the potentially devastating harm caused by Zika.”

For more information about the Zika virus, visit http://www.cdc.gov/zika/.

*This story was updated on August 1.

Aedes aegypti mosquito

Photo courtesy of

Muhammad Mahdi Karim

Officials have announced what is likely the first known occurrence of local mosquito-borne Zika virus transmission in the continental US.*

Fourteen cases of Zika virus in 2 Florida counties are believed to have been caused by bites of local Aedes aegypti mosquitoes.

The Florida Department of Health (DOH) believes that active transmission of the Zika virus is only occurring in a small area in Miami-Dade County.

The US Centers for Disease Control and Prevention (CDC) has recommended that women who are pregnant or thinking of becoming pregnant avoid unnecessary travel to the impacted area. The agency has also issued a guidance for people living in or traveling to the area.

“All the evidence we have seen indicates that this is mosquito-borne transmission that occurred several weeks ago in several blocks in Miami,” said Tom Frieden, MD, director of the CDC.

The exact location is within the boundaries of the following area: NW 5th Avenue to the west, US 1 to the east, NW/NE 38th Street to the north and NW/NE 20th Street to the south. This is about one square mile.

Protecting the blood supply

The US Food and Drug Administration (FDA) has requested that all blood centers in Miami-Dade and Broward counties stop collecting blood immediately.

Blood centers in these counties can resume blood collection once they begin testing each unit of blood with an available investigational donor screening test for Zika virus RNA or once they implement the use of an approved or investigational pathogen inactivation technology.

The FDA also recommended that blood centers in nearby counties implement the same precautions as soon as possible to help maintain the safety of the blood supply. The agency has encouraged screening of the blood supply in regions of the US at risk of local mosquito-borne Zika transmission.

The FDA said it is working with companies that are making blood screening tests available under an Investigational New Drug (IND) application to ensure these companies are ready to expand testing as needed. Blood collection centers may choose to participate in testing under an IND even in the absence of local mosquito-borne transmission of Zika virus.

Florida/CDC response

Florida state officials have implemented mosquito control measures and a community-wide search for additional Zika cases. Thus far, Florida’s DOH has conducted testing for the Zika virus in more than 2300 people statewide.

The DOH has activated the Joint Information Center within the State Emergency Operations Center to ensure the area impacted by local transmission of the Zika virus has coordinated access to information and resources.

The DOH has also begun the process of contracting with commercial pest control companies to enhance and expand mosquito mitigation and abatement, including increased spraying, in the impacted area.

Earlier this year, Florida’s governor, Rick Scott, directed the State Surgeon General to activate a Zika Virus Information Hotline for Florida residents and visitors. The number for this hotline is 1-855-622-6735.

The CDC said it is coordinating with Florida officials leading the ongoing investigation into local transmission of the Zika virus. At the state’s request, the CDC sent a medical epidemiologist to provide additional assistance.

Governor Scott has also asked the CDC to activate a CDC Emergency Response Team to assist the DOH and other partners in their investigation, sample collection, and mosquito control efforts.

To date, the CDC has provided Florida with more than $8 million in Zika-specific funding and about $27 million in emergency preparedness funding that can be used for Zika response efforts.

“We have been working with state and local governments to prepare for the likelihood of local mosquito-borne Zika virus transmission in the continental United States and Hawaii,” said Lyle Petersen, MD, incident manager for CDC’s Zika virus response.

“We anticipate that there may be additional cases of ‘homegrown’ Zika in the coming weeks. Our top priority is to protect pregnant women from the potentially devastating harm caused by Zika.”

For more information about the Zika virus, visit http://www.cdc.gov/zika/.

*This story was updated on August 1.

VANCOUVER—MD1003, a pharmaceutical-grade formulation of biotin, reverses disease progression in a significant proportion of patients with progressive multiple sclerosis (MS), according to research presented at the 68th Annual Meeting of the American Academy of Neurology. The drug is safe and remains effective throughout two years of treatment. Delayed treatment with MD1003 is beneficial, but the delay results in higher levels of disability, compared with immediate treatment.

The drug, however, does not significantly improve visual acuity, compared with placebo, in patients with relapsing-remitting or progressive MS and chronic optic neuropathy, said Ayman Tourbah, MD, PhD, Professor of Neurology at Centre Hospitalier Universitaire in Reims, France.

MD1003 and Disease Progression

To investigate MD1003’s effect on disease progression in patients with progressive MS, Dr. Tourbah and colleagues conducted a placebo-controlled, double-blind study. Eligible patients had primary or secondary progressive MS and an Expanded Disability Status Scale (EDSS) score between 4.5 and 7. In addition, participants had to have had disease progression in the previous two years without evidence of clinical or MRI inflammatory activity within the previous year.

In the first phase of the trial, which lasted for 12 months, patients were randomized 2:1 to MD1003 or placebo. A 12-month extension phase followed, in which all patients received MD1003. Patients and clinicians remained blinded to the treatment assignments of the double-blind phase. The trial’s primary end point was the proportion of patients that improved at month nine and had confirmed improvement at month 12 on EDSS or the Timed 25-Foot Walk, compared with the best baseline measures.

In all, 103 patients were randomized to MD1003, and 51 patients were randomized to placebo. Ninety-one patients from the MD1003 group entered the extension phase, along with 42 patients from the placebo group. In the extension phase, 17 patients originally assigned to MD1003 and four patients originally assigned to placebo discontinued treatment. The main reason for discontinuation in both arms was consent withdrawal.

At baseline, the researchers observed no major differences between treatment arms with regard to sex ratio, mean age, mean disease duration, and mean EDSS score. Slightly more patients in the MD1003 arm had primary progressive MS than in the placebo arm. Approximately 40% of patients were taking concomitant disease-modifying therapies.

In the double-blind phase, 12.6% of patients receiving MD1003 had improvement at month nine and confirmed improvement at month 12. No patient receiving placebo had these outcomes, and the difference between groups was statistically significant. In the extension phase, treatment efficacy was maintained among patients randomized to MD1003 and became apparent in patients who were switched from placebo to MD1003. The level of disability remained higher in the latter group, however.

The rate of adverse events was consistent from the trial’s double-blind phase through its extension phase. The most frequent side effects were infections and infestations and disorders involving the nervous, gastrointestinal, musculoskeletal, and connective tissue systems. Patients originally randomized to placebo did not have more adverse events after switching to MD1003. A few cases of apparent hyperthyroidism were encountered. These are known to be related to interferences between high doses of biotin and biotin-based laboratory tests. Two cases of neoplasm were reported in the extension phase and were not reported as related to the treatment.

“This is the first time that a drug has reversed the progression of the disease in a statistically significant proportion of patients,” said Dr. Tourbah. “Almost no progression was observed in patients treated with MD1003 for 24 months, and this has never been observed before. When we compare these results to other trials in progressive MS that involved more than 6,000 patients overall, this is clearly the best effect size ever observed.”

MD1003 and Visual Acuity

In a separate study, Dr. Tourbah and colleagues analyzed the efficacy of MD1003, compared with placebo, in patients with relapsing-remitting or progressive MS and visual loss related to chronic optic neuropathy. Eligible participants had at least one eye with confirmed visual acuity of 20/40 or less on a standard chart, and worsening of visual acuity within the previous three years. The investigators categorized patients as having progressive optic neuropathy (ie, progressive visual loss observed at two separate ophthalmologic examinations within the three years preceding inclusion) or nonprogressive optic neuropathy (ie, a fixed visual loss for six months or more following an episode of acute optic neuritis).

Patients were randomized 2:1 to MD1003 or placebo for six months. In a subsequent six-month extension phase, patients on placebo were switched to MD1003. Patients and clinicians remained blinded to the treatments that had been given in the double-blind phase. The primary end point was the mean change in visual acuity between month zero and month six in the eye with worse visual acuity at baseline and visual worsening within the previous three years. Dr. Tourbah and colleagues used the Early Treatment Diabetic Retinopathy Study chart at 100% to evaluate visual acuity.

In all, 65 patients were randomized to MD1003, and 28 patients to placebo. One patient did not enter the extension phase of the trial. Demographic characteristics were similar in the two treatment arms, but the majority of patients had nonprogressive chronic optic neuropathy, especially in the placebo arm. Slightly more patients randomized to MD1003 were taking disease-modifying therapies, compared with the placebo arm.

At six months, visual acuity improved in all patients. Improvement was more pronounced in patients receiving MD1003, but the difference between groups was not statistically significant. When the investigators examined only patients with nonprogressive chronic optic neuropathy, they found no difference between treatment groups at six months. When they examined participants with progressive chronic optic neuropathy, however, patients randomized to MD1003 had improved visual acuity at six months, while patients randomized to placebo had worsened visual acuity.

In the extension phase, patients who had improved on placebo continued to improve after switching to MD1003, and patients who had improved on MD1003 continued to improve. The researchers saw no differences in visual acuity between groups at 12 months. Among participants with nonprogressive chronic optic neuropathy, visual acuity improved in both treatment arms, and the researchers saw little difference between them at 12 months. Among patients with progressive chronic optic neuropathy, disease progression stopped in participants who switched from placebo to MD1003.

These results suggest that the treatment has no indication in patients with relapsing-remitting MS and show a trend toward efficacy in patients with progressive chronic optic neuropathy, which is consistent with the results of the MS-SPI study.

In addition, Dr. Tourbah and colleagues observed no major differences between treatment arms regarding the most frequent adverse events (ie, infections and infestations, nervous system disorders, and intestinal disorders). They noted, however, that more patients receiving MD1003 had relapses, compared with patients receiving placebo. “Whether MD1003 may trigger exacerbations in patients with relapsing-remitting MS deserves further investigation,” Dr. Tourbah concluded.

—Erik Greb

VANCOUVER—MD1003, a pharmaceutical-grade formulation of biotin, reverses disease progression in a significant proportion of patients with progressive multiple sclerosis (MS), according to research presented at the 68th Annual Meeting of the American Academy of Neurology. The drug is safe and remains effective throughout two years of treatment. Delayed treatment with MD1003 is beneficial, but the delay results in higher levels of disability, compared with immediate treatment.

The drug, however, does not significantly improve visual acuity, compared with placebo, in patients with relapsing-remitting or progressive MS and chronic optic neuropathy, said Ayman Tourbah, MD, PhD, Professor of Neurology at Centre Hospitalier Universitaire in Reims, France.

MD1003 and Disease Progression

To investigate MD1003’s effect on disease progression in patients with progressive MS, Dr. Tourbah and colleagues conducted a placebo-controlled, double-blind study. Eligible patients had primary or secondary progressive MS and an Expanded Disability Status Scale (EDSS) score between 4.5 and 7. In addition, participants had to have had disease progression in the previous two years without evidence of clinical or MRI inflammatory activity within the previous year.

In the first phase of the trial, which lasted for 12 months, patients were randomized 2:1 to MD1003 or placebo. A 12-month extension phase followed, in which all patients received MD1003. Patients and clinicians remained blinded to the treatment assignments of the double-blind phase. The trial’s primary end point was the proportion of patients that improved at month nine and had confirmed improvement at month 12 on EDSS or the Timed 25-Foot Walk, compared with the best baseline measures.

In all, 103 patients were randomized to MD1003, and 51 patients were randomized to placebo. Ninety-one patients from the MD1003 group entered the extension phase, along with 42 patients from the placebo group. In the extension phase, 17 patients originally assigned to MD1003 and four patients originally assigned to placebo discontinued treatment. The main reason for discontinuation in both arms was consent withdrawal.

At baseline, the researchers observed no major differences between treatment arms with regard to sex ratio, mean age, mean disease duration, and mean EDSS score. Slightly more patients in the MD1003 arm had primary progressive MS than in the placebo arm. Approximately 40% of patients were taking concomitant disease-modifying therapies.

In the double-blind phase, 12.6% of patients receiving MD1003 had improvement at month nine and confirmed improvement at month 12. No patient receiving placebo had these outcomes, and the difference between groups was statistically significant. In the extension phase, treatment efficacy was maintained among patients randomized to MD1003 and became apparent in patients who were switched from placebo to MD1003. The level of disability remained higher in the latter group, however.

The rate of adverse events was consistent from the trial’s double-blind phase through its extension phase. The most frequent side effects were infections and infestations and disorders involving the nervous, gastrointestinal, musculoskeletal, and connective tissue systems. Patients originally randomized to placebo did not have more adverse events after switching to MD1003. A few cases of apparent hyperthyroidism were encountered. These are known to be related to interferences between high doses of biotin and biotin-based laboratory tests. Two cases of neoplasm were reported in the extension phase and were not reported as related to the treatment.

“This is the first time that a drug has reversed the progression of the disease in a statistically significant proportion of patients,” said Dr. Tourbah. “Almost no progression was observed in patients treated with MD1003 for 24 months, and this has never been observed before. When we compare these results to other trials in progressive MS that involved more than 6,000 patients overall, this is clearly the best effect size ever observed.”

MD1003 and Visual Acuity

In a separate study, Dr. Tourbah and colleagues analyzed the efficacy of MD1003, compared with placebo, in patients with relapsing-remitting or progressive MS and visual loss related to chronic optic neuropathy. Eligible participants had at least one eye with confirmed visual acuity of 20/40 or less on a standard chart, and worsening of visual acuity within the previous three years. The investigators categorized patients as having progressive optic neuropathy (ie, progressive visual loss observed at two separate ophthalmologic examinations within the three years preceding inclusion) or nonprogressive optic neuropathy (ie, a fixed visual loss for six months or more following an episode of acute optic neuritis).

Patients were randomized 2:1 to MD1003 or placebo for six months. In a subsequent six-month extension phase, patients on placebo were switched to MD1003. Patients and clinicians remained blinded to the treatments that had been given in the double-blind phase. The primary end point was the mean change in visual acuity between month zero and month six in the eye with worse visual acuity at baseline and visual worsening within the previous three years. Dr. Tourbah and colleagues used the Early Treatment Diabetic Retinopathy Study chart at 100% to evaluate visual acuity.

In all, 65 patients were randomized to MD1003, and 28 patients to placebo. One patient did not enter the extension phase of the trial. Demographic characteristics were similar in the two treatment arms, but the majority of patients had nonprogressive chronic optic neuropathy, especially in the placebo arm. Slightly more patients randomized to MD1003 were taking disease-modifying therapies, compared with the placebo arm.

At six months, visual acuity improved in all patients. Improvement was more pronounced in patients receiving MD1003, but the difference between groups was not statistically significant. When the investigators examined only patients with nonprogressive chronic optic neuropathy, they found no difference between treatment groups at six months. When they examined participants with progressive chronic optic neuropathy, however, patients randomized to MD1003 had improved visual acuity at six months, while patients randomized to placebo had worsened visual acuity.

In the extension phase, patients who had improved on placebo continued to improve after switching to MD1003, and patients who had improved on MD1003 continued to improve. The researchers saw no differences in visual acuity between groups at 12 months. Among participants with nonprogressive chronic optic neuropathy, visual acuity improved in both treatment arms, and the researchers saw little difference between them at 12 months. Among patients with progressive chronic optic neuropathy, disease progression stopped in participants who switched from placebo to MD1003.

These results suggest that the treatment has no indication in patients with relapsing-remitting MS and show a trend toward efficacy in patients with progressive chronic optic neuropathy, which is consistent with the results of the MS-SPI study.

In addition, Dr. Tourbah and colleagues observed no major differences between treatment arms regarding the most frequent adverse events (ie, infections and infestations, nervous system disorders, and intestinal disorders). They noted, however, that more patients receiving MD1003 had relapses, compared with patients receiving placebo. “Whether MD1003 may trigger exacerbations in patients with relapsing-remitting MS deserves further investigation,” Dr. Tourbah concluded.

—Erik Greb

VANCOUVER—MD1003, a pharmaceutical-grade formulation of biotin, reverses disease progression in a significant proportion of patients with progressive multiple sclerosis (MS), according to research presented at the 68th Annual Meeting of the American Academy of Neurology. The drug is safe and remains effective throughout two years of treatment. Delayed treatment with MD1003 is beneficial, but the delay results in higher levels of disability, compared with immediate treatment.

The drug, however, does not significantly improve visual acuity, compared with placebo, in patients with relapsing-remitting or progressive MS and chronic optic neuropathy, said Ayman Tourbah, MD, PhD, Professor of Neurology at Centre Hospitalier Universitaire in Reims, France.

MD1003 and Disease Progression

To investigate MD1003’s effect on disease progression in patients with progressive MS, Dr. Tourbah and colleagues conducted a placebo-controlled, double-blind study. Eligible patients had primary or secondary progressive MS and an Expanded Disability Status Scale (EDSS) score between 4.5 and 7. In addition, participants had to have had disease progression in the previous two years without evidence of clinical or MRI inflammatory activity within the previous year.

In the first phase of the trial, which lasted for 12 months, patients were randomized 2:1 to MD1003 or placebo. A 12-month extension phase followed, in which all patients received MD1003. Patients and clinicians remained blinded to the treatment assignments of the double-blind phase. The trial’s primary end point was the proportion of patients that improved at month nine and had confirmed improvement at month 12 on EDSS or the Timed 25-Foot Walk, compared with the best baseline measures.

In all, 103 patients were randomized to MD1003, and 51 patients were randomized to placebo. Ninety-one patients from the MD1003 group entered the extension phase, along with 42 patients from the placebo group. In the extension phase, 17 patients originally assigned to MD1003 and four patients originally assigned to placebo discontinued treatment. The main reason for discontinuation in both arms was consent withdrawal.

At baseline, the researchers observed no major differences between treatment arms with regard to sex ratio, mean age, mean disease duration, and mean EDSS score. Slightly more patients in the MD1003 arm had primary progressive MS than in the placebo arm. Approximately 40% of patients were taking concomitant disease-modifying therapies.

In the double-blind phase, 12.6% of patients receiving MD1003 had improvement at month nine and confirmed improvement at month 12. No patient receiving placebo had these outcomes, and the difference between groups was statistically significant. In the extension phase, treatment efficacy was maintained among patients randomized to MD1003 and became apparent in patients who were switched from placebo to MD1003. The level of disability remained higher in the latter group, however.

The rate of adverse events was consistent from the trial’s double-blind phase through its extension phase. The most frequent side effects were infections and infestations and disorders involving the nervous, gastrointestinal, musculoskeletal, and connective tissue systems. Patients originally randomized to placebo did not have more adverse events after switching to MD1003. A few cases of apparent hyperthyroidism were encountered. These are known to be related to interferences between high doses of biotin and biotin-based laboratory tests. Two cases of neoplasm were reported in the extension phase and were not reported as related to the treatment.

“This is the first time that a drug has reversed the progression of the disease in a statistically significant proportion of patients,” said Dr. Tourbah. “Almost no progression was observed in patients treated with MD1003 for 24 months, and this has never been observed before. When we compare these results to other trials in progressive MS that involved more than 6,000 patients overall, this is clearly the best effect size ever observed.”

MD1003 and Visual Acuity

In a separate study, Dr. Tourbah and colleagues analyzed the efficacy of MD1003, compared with placebo, in patients with relapsing-remitting or progressive MS and visual loss related to chronic optic neuropathy. Eligible participants had at least one eye with confirmed visual acuity of 20/40 or less on a standard chart, and worsening of visual acuity within the previous three years. The investigators categorized patients as having progressive optic neuropathy (ie, progressive visual loss observed at two separate ophthalmologic examinations within the three years preceding inclusion) or nonprogressive optic neuropathy (ie, a fixed visual loss for six months or more following an episode of acute optic neuritis).

Patients were randomized 2:1 to MD1003 or placebo for six months. In a subsequent six-month extension phase, patients on placebo were switched to MD1003. Patients and clinicians remained blinded to the treatments that had been given in the double-blind phase. The primary end point was the mean change in visual acuity between month zero and month six in the eye with worse visual acuity at baseline and visual worsening within the previous three years. Dr. Tourbah and colleagues used the Early Treatment Diabetic Retinopathy Study chart at 100% to evaluate visual acuity.

In all, 65 patients were randomized to MD1003, and 28 patients to placebo. One patient did not enter the extension phase of the trial. Demographic characteristics were similar in the two treatment arms, but the majority of patients had nonprogressive chronic optic neuropathy, especially in the placebo arm. Slightly more patients randomized to MD1003 were taking disease-modifying therapies, compared with the placebo arm.

At six months, visual acuity improved in all patients. Improvement was more pronounced in patients receiving MD1003, but the difference between groups was not statistically significant. When the investigators examined only patients with nonprogressive chronic optic neuropathy, they found no difference between treatment groups at six months. When they examined participants with progressive chronic optic neuropathy, however, patients randomized to MD1003 had improved visual acuity at six months, while patients randomized to placebo had worsened visual acuity.

In the extension phase, patients who had improved on placebo continued to improve after switching to MD1003, and patients who had improved on MD1003 continued to improve. The researchers saw no differences in visual acuity between groups at 12 months. Among participants with nonprogressive chronic optic neuropathy, visual acuity improved in both treatment arms, and the researchers saw little difference between them at 12 months. Among patients with progressive chronic optic neuropathy, disease progression stopped in participants who switched from placebo to MD1003.

These results suggest that the treatment has no indication in patients with relapsing-remitting MS and show a trend toward efficacy in patients with progressive chronic optic neuropathy, which is consistent with the results of the MS-SPI study.

In addition, Dr. Tourbah and colleagues observed no major differences between treatment arms regarding the most frequent adverse events (ie, infections and infestations, nervous system disorders, and intestinal disorders). They noted, however, that more patients receiving MD1003 had relapses, compared with patients receiving placebo. “Whether MD1003 may trigger exacerbations in patients with relapsing-remitting MS deserves further investigation,” Dr. Tourbah concluded.

—Erik Greb

As Oliver Wendell Holmes stated “The great thing in this world is not so much where we stand, as in what direction we are moving.” Where is AGA moving? AGA represents the highest values in the field of gastroenterology and hepatology, and a focus on the care of patients. We need to demonstrate value, maintain certification, discover new treatments, and improve patient care.

The era of reimbursement based on value, quality care is here: AGA is the leading GI society helping you provide quality care and demonstrating to payors that you’re doing so. Medicare is in the midst of shifting to a value and quality-driven physician reimbursement system. AGA is here to help you successfully make the transition. You must learn about the new system and start preparations – decisions made this year will impact your payment in the future.

AGA Institute

An important milestone in the transition to the new system was the recent release of proposed rules related to MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which replaces the flawed Sustainable Growth Rate formula. CHIP is the Children’s Health Insurance Program. Under MACRA, physicians will have a choice – to be paid via the Merit-Based Incentive Payment System (MIPS) or Alternate Payment Models. Most GIs will participate in MIPS. The most important thing you can do now is report on quality. AGA has quality measures and our Digestive Health Recognition Program is a qualified clinical data registry.

AGA must lead our profession to increase the value of the care we provide. High-value, cost-conscious care refers to care that aims to assess the benefits, harms, and costs of interventions and, consequently, to provide care that adds value. Guidance to enhance value of care based on cognitive skills and appropriate use of biomarkers and imaging, and Clinical Practice Updates are complementary to AGA Guidelines.

Gastroenterologists must maintain certification in a system we don’t support. Maintenance of certification is a major issue in medicine. AGA is pushing for change, favoring continuous professional development for gastroenterologists who self-categorize their practice expertise, and participate in assessments having a built‐in remediation experience with access to resources during the testing. Having developed consensus principles authored by AGA, AASLD, ACG, ASGE, ANMS, and NASPGHAN, we have achieved a stop to the 10-year high stakes exam. We have developed an alliance with other internal medicine societies to attempt to co-create MOC of the future.

One area that is a constant in medicine is the need for research. AGA is committed to research and supporting young investigators so that the future is bright for our patients. Every year our foundation gives $2.5 million in research grants and we continue to advocate for increased NIH funding.

Patients need us to better understand digestive disease and discover new treatments. We have extensive patient education tools on the AGA website. AGA supports device and drug makers working to bring new treatments to patients, with dedicated centers: Center for GI Technology, Center for Diagnostics and Therapeutics, and the Center for the Microbiome, which recently received a prestigious grant from the NIH to support microbiome research.

Patients also want evidence-based care and want to participate in choices. We are developing new patient education materials for use AT THE POINT OF CARE, and for inclusion in EHRs to provide automated qualified clinical data registry (QCDR) reporting by gastroenterologists. At present, there are still challenges of interoperability in the electronic environment.

Obesity is a chronic disease concomitant with many GI diseases and reflects an opportunity for obesity management by gastroenterologists through a forthcoming white paper, entitled Practice Guide on Obesity and Weight Management Education, and Resources.

Finally, we recognized Martin Brotman, MD, AGAF, for innumerable contributions over almost 3 decades as a leader of the AGA, and Richard Boland, MD, AGAF, as the Julius Friedenwald Medal awardee.

Dr. Camilleri is the Atherton and Winifred W. Bean Professor and professor of medicine, pharmacology, and physiology, Mayo Clinic College of Medicine Consultant, division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minn.

As Oliver Wendell Holmes stated “The great thing in this world is not so much where we stand, as in what direction we are moving.” Where is AGA moving? AGA represents the highest values in the field of gastroenterology and hepatology, and a focus on the care of patients. We need to demonstrate value, maintain certification, discover new treatments, and improve patient care.

The era of reimbursement based on value, quality care is here: AGA is the leading GI society helping you provide quality care and demonstrating to payors that you’re doing so. Medicare is in the midst of shifting to a value and quality-driven physician reimbursement system. AGA is here to help you successfully make the transition. You must learn about the new system and start preparations – decisions made this year will impact your payment in the future.

AGA Institute

An important milestone in the transition to the new system was the recent release of proposed rules related to MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which replaces the flawed Sustainable Growth Rate formula. CHIP is the Children’s Health Insurance Program. Under MACRA, physicians will have a choice – to be paid via the Merit-Based Incentive Payment System (MIPS) or Alternate Payment Models. Most GIs will participate in MIPS. The most important thing you can do now is report on quality. AGA has quality measures and our Digestive Health Recognition Program is a qualified clinical data registry.

AGA must lead our profession to increase the value of the care we provide. High-value, cost-conscious care refers to care that aims to assess the benefits, harms, and costs of interventions and, consequently, to provide care that adds value. Guidance to enhance value of care based on cognitive skills and appropriate use of biomarkers and imaging, and Clinical Practice Updates are complementary to AGA Guidelines.

Gastroenterologists must maintain certification in a system we don’t support. Maintenance of certification is a major issue in medicine. AGA is pushing for change, favoring continuous professional development for gastroenterologists who self-categorize their practice expertise, and participate in assessments having a built‐in remediation experience with access to resources during the testing. Having developed consensus principles authored by AGA, AASLD, ACG, ASGE, ANMS, and NASPGHAN, we have achieved a stop to the 10-year high stakes exam. We have developed an alliance with other internal medicine societies to attempt to co-create MOC of the future.

One area that is a constant in medicine is the need for research. AGA is committed to research and supporting young investigators so that the future is bright for our patients. Every year our foundation gives $2.5 million in research grants and we continue to advocate for increased NIH funding.

Patients need us to better understand digestive disease and discover new treatments. We have extensive patient education tools on the AGA website. AGA supports device and drug makers working to bring new treatments to patients, with dedicated centers: Center for GI Technology, Center for Diagnostics and Therapeutics, and the Center for the Microbiome, which recently received a prestigious grant from the NIH to support microbiome research.

Patients also want evidence-based care and want to participate in choices. We are developing new patient education materials for use AT THE POINT OF CARE, and for inclusion in EHRs to provide automated qualified clinical data registry (QCDR) reporting by gastroenterologists. At present, there are still challenges of interoperability in the electronic environment.

Obesity is a chronic disease concomitant with many GI diseases and reflects an opportunity for obesity management by gastroenterologists through a forthcoming white paper, entitled Practice Guide on Obesity and Weight Management Education, and Resources.

Finally, we recognized Martin Brotman, MD, AGAF, for innumerable contributions over almost 3 decades as a leader of the AGA, and Richard Boland, MD, AGAF, as the Julius Friedenwald Medal awardee.

Dr. Camilleri is the Atherton and Winifred W. Bean Professor and professor of medicine, pharmacology, and physiology, Mayo Clinic College of Medicine Consultant, division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minn.

As Oliver Wendell Holmes stated “The great thing in this world is not so much where we stand, as in what direction we are moving.” Where is AGA moving? AGA represents the highest values in the field of gastroenterology and hepatology, and a focus on the care of patients. We need to demonstrate value, maintain certification, discover new treatments, and improve patient care.

The era of reimbursement based on value, quality care is here: AGA is the leading GI society helping you provide quality care and demonstrating to payors that you’re doing so. Medicare is in the midst of shifting to a value and quality-driven physician reimbursement system. AGA is here to help you successfully make the transition. You must learn about the new system and start preparations – decisions made this year will impact your payment in the future.

AGA Institute

An important milestone in the transition to the new system was the recent release of proposed rules related to MACRA (Medicare Access and CHIP Reauthorization Act of 2015), which replaces the flawed Sustainable Growth Rate formula. CHIP is the Children’s Health Insurance Program. Under MACRA, physicians will have a choice – to be paid via the Merit-Based Incentive Payment System (MIPS) or Alternate Payment Models. Most GIs will participate in MIPS. The most important thing you can do now is report on quality. AGA has quality measures and our Digestive Health Recognition Program is a qualified clinical data registry.

AGA must lead our profession to increase the value of the care we provide. High-value, cost-conscious care refers to care that aims to assess the benefits, harms, and costs of interventions and, consequently, to provide care that adds value. Guidance to enhance value of care based on cognitive skills and appropriate use of biomarkers and imaging, and Clinical Practice Updates are complementary to AGA Guidelines.

Gastroenterologists must maintain certification in a system we don’t support. Maintenance of certification is a major issue in medicine. AGA is pushing for change, favoring continuous professional development for gastroenterologists who self-categorize their practice expertise, and participate in assessments having a built‐in remediation experience with access to resources during the testing. Having developed consensus principles authored by AGA, AASLD, ACG, ASGE, ANMS, and NASPGHAN, we have achieved a stop to the 10-year high stakes exam. We have developed an alliance with other internal medicine societies to attempt to co-create MOC of the future.

One area that is a constant in medicine is the need for research. AGA is committed to research and supporting young investigators so that the future is bright for our patients. Every year our foundation gives $2.5 million in research grants and we continue to advocate for increased NIH funding.

Patients need us to better understand digestive disease and discover new treatments. We have extensive patient education tools on the AGA website. AGA supports device and drug makers working to bring new treatments to patients, with dedicated centers: Center for GI Technology, Center for Diagnostics and Therapeutics, and the Center for the Microbiome, which recently received a prestigious grant from the NIH to support microbiome research.

Patients also want evidence-based care and want to participate in choices. We are developing new patient education materials for use AT THE POINT OF CARE, and for inclusion in EHRs to provide automated qualified clinical data registry (QCDR) reporting by gastroenterologists. At present, there are still challenges of interoperability in the electronic environment.

Obesity is a chronic disease concomitant with many GI diseases and reflects an opportunity for obesity management by gastroenterologists through a forthcoming white paper, entitled Practice Guide on Obesity and Weight Management Education, and Resources.

Finally, we recognized Martin Brotman, MD, AGAF, for innumerable contributions over almost 3 decades as a leader of the AGA, and Richard Boland, MD, AGAF, as the Julius Friedenwald Medal awardee.

Dr. Camilleri is the Atherton and Winifred W. Bean Professor and professor of medicine, pharmacology, and physiology, Mayo Clinic College of Medicine Consultant, division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minn.

Facilitators: Christopher Russo, MD, FAAP, Laura Hodo, MD, and Lauren Wilson, MD

This session discussed ways to design and improve education within community hospital settings. It was done via a didactic session, breakout groups, and an electronic assessment tool that can be used beyond the session. Facilitators included the workshop leaders and co-leaders along with current PHM fellows and educators from community and academic settings.

During the didactic session a general background of importance of education during times of increasing academic and community site affiliations was discussed. This included the strengths of community hospitals for learners such as “appropriate learner autonomy”, “exposure to different career paths”, and “transfer decision-making”.

Some of the challenges discussed in regards to developing an educational structure in community settings included:

1. Logistics

   • Making the case for education
   • Legal framework (i.e. Affiliation agreements, Liability)
   • Finances (i.e. GME funding)
   • Paperwork burden (ex. Licensing, Credentialing)

2. Learning Environment

   • Complementing clinical work with materials
   • Autonomy/Supervision balancing
   • Developing Clinical teachers

The didactic session also reviewed the 6 steps for curriculum development: General Needs Assessment, Targeted Needs Assessment, Goals and Objectives, Educational Strategies, Implementation, and Evaluation/Feedback. Each of these was described in further detail with relevant examples.

Groups were broken out into small groups based on four learner types: Medical Students, Family Medicine Residents, Pediatric Residents, and PHM Fellows. Within each group a “Program Development Matrix” was distributed to assess the support from leadership and logistics within each setting. Each one of these was separated into subgroups such as credentialing, financial support, housing/travel, and preceptor recruitment.

A separate “Curriculum Development Matrix” was utilized during breakout groups that focused on curriculum development. This matrix was broken into 3 areas: Educational Strategies, Implementation, and Evaluation/Feedback. These were broken down into subgroups such as content, identifying resources, and remediation planning. The group was asked to determine short and long term goals with action steps for both of these matrix subgroups.

Overall the session presented a structured way of assessing the educational environment for learners in community settings. It gave tangible tools to develop a needs assessment and planning to achieve the defined goals that can be readily used by sites who wish to develop or improve their current educational framework.

Facilitators: Christopher Russo, MD, FAAP, Laura Hodo, MD, and Lauren Wilson, MD

This session discussed ways to design and improve education within community hospital settings. It was done via a didactic session, breakout groups, and an electronic assessment tool that can be used beyond the session. Facilitators included the workshop leaders and co-leaders along with current PHM fellows and educators from community and academic settings.

During the didactic session a general background of importance of education during times of increasing academic and community site affiliations was discussed. This included the strengths of community hospitals for learners such as “appropriate learner autonomy”, “exposure to different career paths”, and “transfer decision-making”.

Some of the challenges discussed in regards to developing an educational structure in community settings included:

1. Logistics

   • Making the case for education
   • Legal framework (i.e. Affiliation agreements, Liability)
   • Finances (i.e. GME funding)
   • Paperwork burden (ex. Licensing, Credentialing)

2. Learning Environment

   • Complementing clinical work with materials
   • Autonomy/Supervision balancing
   • Developing Clinical teachers

The didactic session also reviewed the 6 steps for curriculum development: General Needs Assessment, Targeted Needs Assessment, Goals and Objectives, Educational Strategies, Implementation, and Evaluation/Feedback. Each of these was described in further detail with relevant examples.

Groups were broken out into small groups based on four learner types: Medical Students, Family Medicine Residents, Pediatric Residents, and PHM Fellows. Within each group a “Program Development Matrix” was distributed to assess the support from leadership and logistics within each setting. Each one of these was separated into subgroups such as credentialing, financial support, housing/travel, and preceptor recruitment.

A separate “Curriculum Development Matrix” was utilized during breakout groups that focused on curriculum development. This matrix was broken into 3 areas: Educational Strategies, Implementation, and Evaluation/Feedback. These were broken down into subgroups such as content, identifying resources, and remediation planning. The group was asked to determine short and long term goals with action steps for both of these matrix subgroups.

Overall the session presented a structured way of assessing the educational environment for learners in community settings. It gave tangible tools to develop a needs assessment and planning to achieve the defined goals that can be readily used by sites who wish to develop or improve their current educational framework.

Facilitators: Christopher Russo, MD, FAAP, Laura Hodo, MD, and Lauren Wilson, MD

This session discussed ways to design and improve education within community hospital settings. It was done via a didactic session, breakout groups, and an electronic assessment tool that can be used beyond the session. Facilitators included the workshop leaders and co-leaders along with current PHM fellows and educators from community and academic settings.

During the didactic session a general background of importance of education during times of increasing academic and community site affiliations was discussed. This included the strengths of community hospitals for learners such as “appropriate learner autonomy”, “exposure to different career paths”, and “transfer decision-making”.

Some of the challenges discussed in regards to developing an educational structure in community settings included:

1. Logistics

   • Making the case for education
   • Legal framework (i.e. Affiliation agreements, Liability)
   • Finances (i.e. GME funding)
   • Paperwork burden (ex. Licensing, Credentialing)

2. Learning Environment

   • Complementing clinical work with materials
   • Autonomy/Supervision balancing
   • Developing Clinical teachers

The didactic session also reviewed the 6 steps for curriculum development: General Needs Assessment, Targeted Needs Assessment, Goals and Objectives, Educational Strategies, Implementation, and Evaluation/Feedback. Each of these was described in further detail with relevant examples.

Groups were broken out into small groups based on four learner types: Medical Students, Family Medicine Residents, Pediatric Residents, and PHM Fellows. Within each group a “Program Development Matrix” was distributed to assess the support from leadership and logistics within each setting. Each one of these was separated into subgroups such as credentialing, financial support, housing/travel, and preceptor recruitment.

A separate “Curriculum Development Matrix” was utilized during breakout groups that focused on curriculum development. This matrix was broken into 3 areas: Educational Strategies, Implementation, and Evaluation/Feedback. These were broken down into subgroups such as content, identifying resources, and remediation planning. The group was asked to determine short and long term goals with action steps for both of these matrix subgroups.

Overall the session presented a structured way of assessing the educational environment for learners in community settings. It gave tangible tools to develop a needs assessment and planning to achieve the defined goals that can be readily used by sites who wish to develop or improve their current educational framework.

The incidence of parkinsonism and Parkinson’s disease in a Minnesota county may have increased over a 30-year period, primarily in men age 70 or older, according to a study published online ahead of print June 20 in JAMA Neurology. The increased incidence may be due to changes in smoking behavior during that time or other factors, the researchers said. The trend needs to be confirmed in other populations, they added.

“The decline in smoking rates in men may explain in part the increasing incidence of parkinsonism and Parkinson’s disease. However, other environmental or lifestyle risk or protective factors that are related to sex may also be involved such as pesticide use, head trauma, and coffee consumption,” Walter A. Rocca, MD, MPH, of the Mayo Clinic in Rochester, Minnesota, and coauthors said.

Previous studies have found that smoking is associated with reduced risk of Parkinson’s disease, but whether the relationship is causal remains uncertain. Morozova et al suggested that smokers have a 74% reduction in risk of Parkinson’s disease, possibly attributable to nicotine or other tobacco elements. Researchers have speculated that a decline in smoking frequency after its peak in the 1940s and 1950s may have caused an increase in Parkinson’s disease.

To study this question, Dr. Rocca and coauthors investigated time trends and birth cohort trends for the incidence of parkinsonism and Parkinson’s disease in Olmsted County, Minnesota, from 1976 to 2005.

Parkinson’s Disease and Parkinsonism Definitions

The researchers used medical records from the Rochester Epidemiology Project to identify the frequency of Parkinson’s disease and other types of parkinsonism in Olmsted County during the 30-year period. A movement disorder specialist classified all the medical records based on diagnostic criteria. The researchers defined parkinsonism as the presence of at least two of four cardinal signs (ie, rest tremor, bradykinesia, rigidity, and impaired postural reflexes). They defined Parkinson’s disease as parkinsonism with no other cause, no documentation of unresponsiveness to levodopa at doses of at least 1 g per day in combination with carbidopa, and no prominent or early signs of extensive nervous system involvement.

Researchers analyzed 906 incident cases of parkinsonism with onset between January 1, 1976, and December 31, 2005. The median age of onset was 74, and 501 of the patients with parkinsonism were men. Of the 464 patients with Parkinson’s disease, the median age at onset was 73, and 275 of the patients were men. The investigators evaluated changes in incidence rates for men and for women using two age classes: patients younger than 70 and patients age 70 and older. The investigators used negative binomial regression models to evaluate time trends.

Men and Higher Incident Rates

Overall, men had higher rates of parkinsonism and Parkinson’s disease than women. The incidence rate of parkinsonism in men increased from 38.8 cases per 100,000 person-years between 1976 and 1985 to 56.0 cases per 100,000 person-years between 1996 and 2005. The incidence rate of Parkinson’s disease in men increased from 18.2 cases per 100,000 person-years between 1976 and 1985 to 30.4 cases per 100,000 person-years between 1996 and 2005. Compared with that in men younger than 70, the increase in incidence rates was greater for men age 70 or older. There was not a statistically significant increase in incidence rates of parkinsonism or Parkinson’s disease in women, although there was a nonsignificant increase in the incidence rate of Parkinson’s disease in women age 70 or older.

In addition to lifestyle and environmental factors, increased awareness of symptoms, improved access to care, and better recognition of parkinsonism by physicians also could be responsible for the increased incidence observed, the researchers noted.

Limitations of this study include its small population size. In addition, there were no data on potential risk factors for Parkinson’s disease. As a result, researchers were unable to confirm whether decreased smoking or environmental factors were responsible for the increased incidence rates, according to Honglei Chen, MD, PhD, Head of the Aging and Neuroepidemiology Group at NIH, in an accompanying editorial.

—Erica Robinson

The incidence of parkinsonism and Parkinson’s disease in a Minnesota county may have increased over a 30-year period, primarily in men age 70 or older, according to a study published online ahead of print June 20 in JAMA Neurology. The increased incidence may be due to changes in smoking behavior during that time or other factors, the researchers said. The trend needs to be confirmed in other populations, they added.

“The decline in smoking rates in men may explain in part the increasing incidence of parkinsonism and Parkinson’s disease. However, other environmental or lifestyle risk or protective factors that are related to sex may also be involved such as pesticide use, head trauma, and coffee consumption,” Walter A. Rocca, MD, MPH, of the Mayo Clinic in Rochester, Minnesota, and coauthors said.

Previous studies have found that smoking is associated with reduced risk of Parkinson’s disease, but whether the relationship is causal remains uncertain. Morozova et al suggested that smokers have a 74% reduction in risk of Parkinson’s disease, possibly attributable to nicotine or other tobacco elements. Researchers have speculated that a decline in smoking frequency after its peak in the 1940s and 1950s may have caused an increase in Parkinson’s disease.

To study this question, Dr. Rocca and coauthors investigated time trends and birth cohort trends for the incidence of parkinsonism and Parkinson’s disease in Olmsted County, Minnesota, from 1976 to 2005.

Parkinson’s Disease and Parkinsonism Definitions

The researchers used medical records from the Rochester Epidemiology Project to identify the frequency of Parkinson’s disease and other types of parkinsonism in Olmsted County during the 30-year period. A movement disorder specialist classified all the medical records based on diagnostic criteria. The researchers defined parkinsonism as the presence of at least two of four cardinal signs (ie, rest tremor, bradykinesia, rigidity, and impaired postural reflexes). They defined Parkinson’s disease as parkinsonism with no other cause, no documentation of unresponsiveness to levodopa at doses of at least 1 g per day in combination with carbidopa, and no prominent or early signs of extensive nervous system involvement.

Researchers analyzed 906 incident cases of parkinsonism with onset between January 1, 1976, and December 31, 2005. The median age of onset was 74, and 501 of the patients with parkinsonism were men. Of the 464 patients with Parkinson’s disease, the median age at onset was 73, and 275 of the patients were men. The investigators evaluated changes in incidence rates for men and for women using two age classes: patients younger than 70 and patients age 70 and older. The investigators used negative binomial regression models to evaluate time trends.

Men and Higher Incident Rates

Overall, men had higher rates of parkinsonism and Parkinson’s disease than women. The incidence rate of parkinsonism in men increased from 38.8 cases per 100,000 person-years between 1976 and 1985 to 56.0 cases per 100,000 person-years between 1996 and 2005. The incidence rate of Parkinson’s disease in men increased from 18.2 cases per 100,000 person-years between 1976 and 1985 to 30.4 cases per 100,000 person-years between 1996 and 2005. Compared with that in men younger than 70, the increase in incidence rates was greater for men age 70 or older. There was not a statistically significant increase in incidence rates of parkinsonism or Parkinson’s disease in women, although there was a nonsignificant increase in the incidence rate of Parkinson’s disease in women age 70 or older.

In addition to lifestyle and environmental factors, increased awareness of symptoms, improved access to care, and better recognition of parkinsonism by physicians also could be responsible for the increased incidence observed, the researchers noted.

Limitations of this study include its small population size. In addition, there were no data on potential risk factors for Parkinson’s disease. As a result, researchers were unable to confirm whether decreased smoking or environmental factors were responsible for the increased incidence rates, according to Honglei Chen, MD, PhD, Head of the Aging and Neuroepidemiology Group at NIH, in an accompanying editorial.

—Erica Robinson

The incidence of parkinsonism and Parkinson’s disease in a Minnesota county may have increased over a 30-year period, primarily in men age 70 or older, according to a study published online ahead of print June 20 in JAMA Neurology. The increased incidence may be due to changes in smoking behavior during that time or other factors, the researchers said. The trend needs to be confirmed in other populations, they added.

“The decline in smoking rates in men may explain in part the increasing incidence of parkinsonism and Parkinson’s disease. However, other environmental or lifestyle risk or protective factors that are related to sex may also be involved such as pesticide use, head trauma, and coffee consumption,” Walter A. Rocca, MD, MPH, of the Mayo Clinic in Rochester, Minnesota, and coauthors said.

Previous studies have found that smoking is associated with reduced risk of Parkinson’s disease, but whether the relationship is causal remains uncertain. Morozova et al suggested that smokers have a 74% reduction in risk of Parkinson’s disease, possibly attributable to nicotine or other tobacco elements. Researchers have speculated that a decline in smoking frequency after its peak in the 1940s and 1950s may have caused an increase in Parkinson’s disease.

To study this question, Dr. Rocca and coauthors investigated time trends and birth cohort trends for the incidence of parkinsonism and Parkinson’s disease in Olmsted County, Minnesota, from 1976 to 2005.

Parkinson’s Disease and Parkinsonism Definitions

The researchers used medical records from the Rochester Epidemiology Project to identify the frequency of Parkinson’s disease and other types of parkinsonism in Olmsted County during the 30-year period. A movement disorder specialist classified all the medical records based on diagnostic criteria. The researchers defined parkinsonism as the presence of at least two of four cardinal signs (ie, rest tremor, bradykinesia, rigidity, and impaired postural reflexes). They defined Parkinson’s disease as parkinsonism with no other cause, no documentation of unresponsiveness to levodopa at doses of at least 1 g per day in combination with carbidopa, and no prominent or early signs of extensive nervous system involvement.

Researchers analyzed 906 incident cases of parkinsonism with onset between January 1, 1976, and December 31, 2005. The median age of onset was 74, and 501 of the patients with parkinsonism were men. Of the 464 patients with Parkinson’s disease, the median age at onset was 73, and 275 of the patients were men. The investigators evaluated changes in incidence rates for men and for women using two age classes: patients younger than 70 and patients age 70 and older. The investigators used negative binomial regression models to evaluate time trends.

Men and Higher Incident Rates

Overall, men had higher rates of parkinsonism and Parkinson’s disease than women. The incidence rate of parkinsonism in men increased from 38.8 cases per 100,000 person-years between 1976 and 1985 to 56.0 cases per 100,000 person-years between 1996 and 2005. The incidence rate of Parkinson’s disease in men increased from 18.2 cases per 100,000 person-years between 1976 and 1985 to 30.4 cases per 100,000 person-years between 1996 and 2005. Compared with that in men younger than 70, the increase in incidence rates was greater for men age 70 or older. There was not a statistically significant increase in incidence rates of parkinsonism or Parkinson’s disease in women, although there was a nonsignificant increase in the incidence rate of Parkinson’s disease in women age 70 or older.

In addition to lifestyle and environmental factors, increased awareness of symptoms, improved access to care, and better recognition of parkinsonism by physicians also could be responsible for the increased incidence observed, the researchers noted.

Limitations of this study include its small population size. In addition, there were no data on potential risk factors for Parkinson’s disease. As a result, researchers were unable to confirm whether decreased smoking or environmental factors were responsible for the increased incidence rates, according to Honglei Chen, MD, PhD, Head of the Aging and Neuroepidemiology Group at NIH, in an accompanying editorial.

—Erica Robinson

As we embark on Choosing Wisely, pediatric hospitalists gathered to attend this fruitful discussion on not only how to change our way of thinking but also how to feed it forward to our trainees. The barriers to promoting and teaching high value care are plenty and essentially universal to academic and community sites: we have had no formal teaching, there is cultural resistance and there is lack of transparency on costs and charges.

Perhaps the questions we should be asking ourselves, our trainees and our families are:

• Instead of “What’s the matter?” ask “What matters?”
• Instead of asking “Will that test change our management?” ask “Does that test benefit the patient? What are the harms of the test?”

Thinking about effects of tests downstream, the “testing cascade” can be a great mental exercise for the higher-level learner to understand the value, the unknowns we face in our daily decisions and simultaneously improving our understanding of best practices.

A toolkit was provided to help bring back resources and methods to teach high value care in morning report/ case conference settings, bedside teaching and family discussions.

One point is clear though—there is still a long way to go to move the pendulum to the side of value based practice and teaching. There is still controversy on how and whether cost should be discussed with the family. Cost is more than just monetary values—family anxiety and patient harm may resonate more with families as we perfect our skills in shared decision making.

This serves as an exciting time to unite and better our understanding on why we do what we do and deliberately think about downstream effects. High value care curriculum for medical students, residents, fellows and even faculty is an area ripe for further educational and clinical research.

When asking for the Pediatric Value Meal, this is one where I will not Super size it!

Dr. Akshata Hopkins, MD FAAP, is an academic hospitalist at Johns Hopkins All Children's Hospital, St. Petersburg, Fla.

As we embark on Choosing Wisely, pediatric hospitalists gathered to attend this fruitful discussion on not only how to change our way of thinking but also how to feed it forward to our trainees. The barriers to promoting and teaching high value care are plenty and essentially universal to academic and community sites: we have had no formal teaching, there is cultural resistance and there is lack of transparency on costs and charges.

Perhaps the questions we should be asking ourselves, our trainees and our families are:

• Instead of “What’s the matter?” ask “What matters?”
• Instead of asking “Will that test change our management?” ask “Does that test benefit the patient? What are the harms of the test?”

Thinking about effects of tests downstream, the “testing cascade” can be a great mental exercise for the higher-level learner to understand the value, the unknowns we face in our daily decisions and simultaneously improving our understanding of best practices.

A toolkit was provided to help bring back resources and methods to teach high value care in morning report/ case conference settings, bedside teaching and family discussions.

One point is clear though—there is still a long way to go to move the pendulum to the side of value based practice and teaching. There is still controversy on how and whether cost should be discussed with the family. Cost is more than just monetary values—family anxiety and patient harm may resonate more with families as we perfect our skills in shared decision making.

This serves as an exciting time to unite and better our understanding on why we do what we do and deliberately think about downstream effects. High value care curriculum for medical students, residents, fellows and even faculty is an area ripe for further educational and clinical research.

When asking for the Pediatric Value Meal, this is one where I will not Super size it!

Dr. Akshata Hopkins, MD FAAP, is an academic hospitalist at Johns Hopkins All Children's Hospital, St. Petersburg, Fla.

As we embark on Choosing Wisely, pediatric hospitalists gathered to attend this fruitful discussion on not only how to change our way of thinking but also how to feed it forward to our trainees. The barriers to promoting and teaching high value care are plenty and essentially universal to academic and community sites: we have had no formal teaching, there is cultural resistance and there is lack of transparency on costs and charges.

Perhaps the questions we should be asking ourselves, our trainees and our families are:

• Instead of “What’s the matter?” ask “What matters?”
• Instead of asking “Will that test change our management?” ask “Does that test benefit the patient? What are the harms of the test?”

Thinking about effects of tests downstream, the “testing cascade” can be a great mental exercise for the higher-level learner to understand the value, the unknowns we face in our daily decisions and simultaneously improving our understanding of best practices.

A toolkit was provided to help bring back resources and methods to teach high value care in morning report/ case conference settings, bedside teaching and family discussions.

One point is clear though—there is still a long way to go to move the pendulum to the side of value based practice and teaching. There is still controversy on how and whether cost should be discussed with the family. Cost is more than just monetary values—family anxiety and patient harm may resonate more with families as we perfect our skills in shared decision making.

This serves as an exciting time to unite and better our understanding on why we do what we do and deliberately think about downstream effects. High value care curriculum for medical students, residents, fellows and even faculty is an area ripe for further educational and clinical research.

When asking for the Pediatric Value Meal, this is one where I will not Super size it!

Dr. Akshata Hopkins, MD FAAP, is an academic hospitalist at Johns Hopkins All Children's Hospital, St. Petersburg, Fla.