Micrograph showing
mycosis fungoides

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted SGX301 (synthetic hypericin) Promising Innovative Medicine (PIM) designation for the treatment of cutaneous T-cell lymphoma (CTCL).

The PIM designation is the first step toward inclusion in the Early Access to Medicines Scheme (EAMS). 

EAMS provides early access to new medicines for patients with life-threatening and seriously debilitating conditions.

PIM status is awarded following an assessment of early nonclinical and clinical data by the MHRA.

PIM designation has been created as an early signal to companies that a product’s development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme once further development work has been conducted. 

In the second phase, the product is made available to UK patients before a marketing authorization is approved.

The requirements for PIM designation are:

1. The condition should be life-threatening or seriously debilitating with a high unmet medical need (ie, there is no method of treatment, diagnosis, or prevention available, or existing methods have serious limitations).
2. The medicinal product is likely to offer a major advantage over methods currently used in the UK.
3. The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit-risk balance. A positive benefit-risk balance should be based on preliminary scientific evidence, as justified by the applicant.

About SGX301

SGX301 is a photodynamic therapy utilizing safe, visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a photosensitizer that is applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. 

Combined with photoactivation, hypericin has demonstrated significant antiproliferative effects on activated, normal human lymphoid cells and inhibited the growth of malignant T cells isolated from CTCL patients. Topical hypericin has also proven safe in a phase 1 study of healthy volunteers.

In a phase 2 trial of patients with CTCL (mycosis fungoides only) or psoriasis, topical hypericin conferred a significant improvement over placebo. Among CTCL patients, the treatment prompted a response rate of 58.3%, compared to an 8.3% response rate for placebo (P≤0.04).

Topical hypericin was also well tolerated in this trial. There were no deaths or serious adverse events related to the treatment. However, there were reports of mild to moderate burning, itching, erythema, and pruritus at the application site.

A phase 3 trial of SGX301 is currently recruiting patients. SGX301 is under development by Soligenix, Inc.

Micrograph showing
mycosis fungoides

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted SGX301 (synthetic hypericin) Promising Innovative Medicine (PIM) designation for the treatment of cutaneous T-cell lymphoma (CTCL).

The PIM designation is the first step toward inclusion in the Early Access to Medicines Scheme (EAMS). 

EAMS provides early access to new medicines for patients with life-threatening and seriously debilitating conditions.

PIM status is awarded following an assessment of early nonclinical and clinical data by the MHRA.

PIM designation has been created as an early signal to companies that a product’s development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme once further development work has been conducted. 

In the second phase, the product is made available to UK patients before a marketing authorization is approved.

The requirements for PIM designation are:

1. The condition should be life-threatening or seriously debilitating with a high unmet medical need (ie, there is no method of treatment, diagnosis, or prevention available, or existing methods have serious limitations).
2. The medicinal product is likely to offer a major advantage over methods currently used in the UK.
3. The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit-risk balance. A positive benefit-risk balance should be based on preliminary scientific evidence, as justified by the applicant.

About SGX301

SGX301 is a photodynamic therapy utilizing safe, visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a photosensitizer that is applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. 

Combined with photoactivation, hypericin has demonstrated significant antiproliferative effects on activated, normal human lymphoid cells and inhibited the growth of malignant T cells isolated from CTCL patients. Topical hypericin has also proven safe in a phase 1 study of healthy volunteers.

In a phase 2 trial of patients with CTCL (mycosis fungoides only) or psoriasis, topical hypericin conferred a significant improvement over placebo. Among CTCL patients, the treatment prompted a response rate of 58.3%, compared to an 8.3% response rate for placebo (P≤0.04).

Topical hypericin was also well tolerated in this trial. There were no deaths or serious adverse events related to the treatment. However, there were reports of mild to moderate burning, itching, erythema, and pruritus at the application site.

A phase 3 trial of SGX301 is currently recruiting patients. SGX301 is under development by Soligenix, Inc.

Micrograph showing
mycosis fungoides

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted SGX301 (synthetic hypericin) Promising Innovative Medicine (PIM) designation for the treatment of cutaneous T-cell lymphoma (CTCL).

The PIM designation is the first step toward inclusion in the Early Access to Medicines Scheme (EAMS). 

EAMS provides early access to new medicines for patients with life-threatening and seriously debilitating conditions.

PIM status is awarded following an assessment of early nonclinical and clinical data by the MHRA.

PIM designation has been created as an early signal to companies that a product’s development plan is appropriate and indicates that a product could be a candidate for the second phase of the EAMS scheme once further development work has been conducted. 

In the second phase, the product is made available to UK patients before a marketing authorization is approved.

The requirements for PIM designation are:

1. The condition should be life-threatening or seriously debilitating with a high unmet medical need (ie, there is no method of treatment, diagnosis, or prevention available, or existing methods have serious limitations).
2. The medicinal product is likely to offer a major advantage over methods currently used in the UK.
3. The potential adverse effects of the medicinal product are likely to be outweighed by the benefits, allowing for the reasonable expectation of a positive benefit-risk balance. A positive benefit-risk balance should be based on preliminary scientific evidence, as justified by the applicant.

About SGX301

SGX301 is a photodynamic therapy utilizing safe, visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a photosensitizer that is applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. 

Combined with photoactivation, hypericin has demonstrated significant antiproliferative effects on activated, normal human lymphoid cells and inhibited the growth of malignant T cells isolated from CTCL patients. Topical hypericin has also proven safe in a phase 1 study of healthy volunteers.

In a phase 2 trial of patients with CTCL (mycosis fungoides only) or psoriasis, topical hypericin conferred a significant improvement over placebo. Among CTCL patients, the treatment prompted a response rate of 58.3%, compared to an 8.3% response rate for placebo (P≤0.04).

Topical hypericin was also well tolerated in this trial. There were no deaths or serious adverse events related to the treatment. However, there were reports of mild to moderate burning, itching, erythema, and pruritus at the application site.

A phase 3 trial of SGX301 is currently recruiting patients. SGX301 is under development by Soligenix, Inc.

Antihemophilic factor

In a survey of 200 adults with hemophilia A, most were not aware that factor VIII (FVIII) products can be stored at room temperature.

A majority of patients surveyed thought FVIII products must be stored in the refrigerator at all times.

The minority of

patients who did store FVIII at room temperature felt significantly

more satisfied with their treatment and less restricted in their daily

lives than patients who refrigerated FVIII.

“People living with hemophilia A can feel restricted in their daily life based on the misconception that all FVIII treatments must be stored in the refrigerator,” said Mariasanta Napolitano, MD, of the University of Palermo in Italy.

“It is important that healthcare professionals communicate to patients that some FVIII products can be used portably and at room temperature, to enable them to go about their daily lives as actively as they wish.”

Dr Napolitano and her colleagues presented the results of this survey at the 10th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD, poster P024).

The researchers conducted the survey in adults with hemophilia A in 7 countries. Face-to-face surveys were conducted with 90 people in the European Union (France, Italy, and UK) and 90 people in Latin America (Argentina, Brazil, and Mexico). Online surveys were conducted with 20 people in Japan.

The questionnaire covered current use of FVIII products, patient satisfaction, and restrictions in daily life using verbalized rating scales (eg, “not restricted at all / somewhat restricted / restricted / strongly restricted”).

Seventy-four percent of patients used FVII as prophylaxis, and 26% used on-demand treatment. Sixty-seven percent used recombinant FVIII, and 33% used plasma-derived FVIII.

Storage

Most patients—85%—stored their FVIII product in the refrigerator, with 15% storing their treatment at room temperature.

Of those storing FVIII in the refrigerator, 88% said FVIII must be stored in the refrigerator at all times. Seventy-nine percent of patients said they worry about the temperature at which FVIII is stored.

Seventy-four percent said they wait for their FVIII product to reach room temperature before mixing and injecting it. The median wait time was 10 minutes.

Sixty-two percent of patients said an injection with cold FVIII is more unpleasant than an injection with room temperature FVIII.

Satisfaction

Patients storing FVIII at room temperature were significantly more likely than those storing FVIII in the refrigerator to report overall satisfaction with their FVIII product (52% vs 28%, P<0.05).

Patients storing FVIII at room temperature were also significantly more likely to report satisfaction with:

• Product efficacy (61% vs 43%, P<0.05)
• The procedure of mixing the product before injection (39% vs 22%, P<0.05)
• The flexibility of storage depending on the patients’ needs (55% vs 18%, P<0.05)
• The length of time the product can be stored outside the refrigerator (45% vs 19%, P<0.05)
• The size of vials (42% vs 18%, P<0.05)
• Storage temperature (39% vs 15%, P<0.05).

Daily life

Patients storing FVIII at room temperature travelled significantly more often—16 times per year vs 9 times per year (P<0.01).

Nineteen percent of these patients felt that storing, preparing, and mixing FVIII is disruptive to the normal course of the day, compared to 35% of patients who store FVIII in the refrigerator (P<0.05).

Significantly fewer patients in the room-temperature group said they feel restricted when it comes to sports activities, traveling, and their evening routine (P<0.05).

Forty-eight percent of patients storing FVIII at room temperature said they feel relaxed using FVIII in their daily life, compared to 20% of patients storing FVIII in the refrigerator (P<0.05).

Antihemophilic factor

In a survey of 200 adults with hemophilia A, most were not aware that factor VIII (FVIII) products can be stored at room temperature.

A majority of patients surveyed thought FVIII products must be stored in the refrigerator at all times.

The minority of

patients who did store FVIII at room temperature felt significantly

more satisfied with their treatment and less restricted in their daily

lives than patients who refrigerated FVIII.

“People living with hemophilia A can feel restricted in their daily life based on the misconception that all FVIII treatments must be stored in the refrigerator,” said Mariasanta Napolitano, MD, of the University of Palermo in Italy.

“It is important that healthcare professionals communicate to patients that some FVIII products can be used portably and at room temperature, to enable them to go about their daily lives as actively as they wish.”

Dr Napolitano and her colleagues presented the results of this survey at the 10th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD, poster P024).

The researchers conducted the survey in adults with hemophilia A in 7 countries. Face-to-face surveys were conducted with 90 people in the European Union (France, Italy, and UK) and 90 people in Latin America (Argentina, Brazil, and Mexico). Online surveys were conducted with 20 people in Japan.

The questionnaire covered current use of FVIII products, patient satisfaction, and restrictions in daily life using verbalized rating scales (eg, “not restricted at all / somewhat restricted / restricted / strongly restricted”).

Seventy-four percent of patients used FVII as prophylaxis, and 26% used on-demand treatment. Sixty-seven percent used recombinant FVIII, and 33% used plasma-derived FVIII.

Storage

Most patients—85%—stored their FVIII product in the refrigerator, with 15% storing their treatment at room temperature.

Of those storing FVIII in the refrigerator, 88% said FVIII must be stored in the refrigerator at all times. Seventy-nine percent of patients said they worry about the temperature at which FVIII is stored.

Seventy-four percent said they wait for their FVIII product to reach room temperature before mixing and injecting it. The median wait time was 10 minutes.

Sixty-two percent of patients said an injection with cold FVIII is more unpleasant than an injection with room temperature FVIII.

Satisfaction

Patients storing FVIII at room temperature were significantly more likely than those storing FVIII in the refrigerator to report overall satisfaction with their FVIII product (52% vs 28%, P<0.05).

Patients storing FVIII at room temperature were also significantly more likely to report satisfaction with:

• Product efficacy (61% vs 43%, P<0.05)
• The procedure of mixing the product before injection (39% vs 22%, P<0.05)
• The flexibility of storage depending on the patients’ needs (55% vs 18%, P<0.05)
• The length of time the product can be stored outside the refrigerator (45% vs 19%, P<0.05)
• The size of vials (42% vs 18%, P<0.05)
• Storage temperature (39% vs 15%, P<0.05).

Daily life

Patients storing FVIII at room temperature travelled significantly more often—16 times per year vs 9 times per year (P<0.01).

Nineteen percent of these patients felt that storing, preparing, and mixing FVIII is disruptive to the normal course of the day, compared to 35% of patients who store FVIII in the refrigerator (P<0.05).

Significantly fewer patients in the room-temperature group said they feel restricted when it comes to sports activities, traveling, and their evening routine (P<0.05).

Forty-eight percent of patients storing FVIII at room temperature said they feel relaxed using FVIII in their daily life, compared to 20% of patients storing FVIII in the refrigerator (P<0.05).

Antihemophilic factor

In a survey of 200 adults with hemophilia A, most were not aware that factor VIII (FVIII) products can be stored at room temperature.

A majority of patients surveyed thought FVIII products must be stored in the refrigerator at all times.

The minority of

patients who did store FVIII at room temperature felt significantly

more satisfied with their treatment and less restricted in their daily

lives than patients who refrigerated FVIII.

“People living with hemophilia A can feel restricted in their daily life based on the misconception that all FVIII treatments must be stored in the refrigerator,” said Mariasanta Napolitano, MD, of the University of Palermo in Italy.

“It is important that healthcare professionals communicate to patients that some FVIII products can be used portably and at room temperature, to enable them to go about their daily lives as actively as they wish.”

Dr Napolitano and her colleagues presented the results of this survey at the 10th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD, poster P024).

The researchers conducted the survey in adults with hemophilia A in 7 countries. Face-to-face surveys were conducted with 90 people in the European Union (France, Italy, and UK) and 90 people in Latin America (Argentina, Brazil, and Mexico). Online surveys were conducted with 20 people in Japan.

The questionnaire covered current use of FVIII products, patient satisfaction, and restrictions in daily life using verbalized rating scales (eg, “not restricted at all / somewhat restricted / restricted / strongly restricted”).

Seventy-four percent of patients used FVII as prophylaxis, and 26% used on-demand treatment. Sixty-seven percent used recombinant FVIII, and 33% used plasma-derived FVIII.

Storage

Most patients—85%—stored their FVIII product in the refrigerator, with 15% storing their treatment at room temperature.

Of those storing FVIII in the refrigerator, 88% said FVIII must be stored in the refrigerator at all times. Seventy-nine percent of patients said they worry about the temperature at which FVIII is stored.

Seventy-four percent said they wait for their FVIII product to reach room temperature before mixing and injecting it. The median wait time was 10 minutes.

Sixty-two percent of patients said an injection with cold FVIII is more unpleasant than an injection with room temperature FVIII.

Satisfaction

Patients storing FVIII at room temperature were significantly more likely than those storing FVIII in the refrigerator to report overall satisfaction with their FVIII product (52% vs 28%, P<0.05).

Patients storing FVIII at room temperature were also significantly more likely to report satisfaction with:

• Product efficacy (61% vs 43%, P<0.05)
• The procedure of mixing the product before injection (39% vs 22%, P<0.05)
• The flexibility of storage depending on the patients’ needs (55% vs 18%, P<0.05)
• The length of time the product can be stored outside the refrigerator (45% vs 19%, P<0.05)
• The size of vials (42% vs 18%, P<0.05)
• Storage temperature (39% vs 15%, P<0.05).

Daily life

Patients storing FVIII at room temperature travelled significantly more often—16 times per year vs 9 times per year (P<0.01).

Nineteen percent of these patients felt that storing, preparing, and mixing FVIII is disruptive to the normal course of the day, compared to 35% of patients who store FVIII in the refrigerator (P<0.05).

Significantly fewer patients in the room-temperature group said they feel restricted when it comes to sports activities, traveling, and their evening routine (P<0.05).

Forty-eight percent of patients storing FVIII at room temperature said they feel relaxed using FVIII in their daily life, compared to 20% of patients storing FVIII in the refrigerator (P<0.05).

Prescription pills

New research published in Blood suggests young patients with acute lymphoblastic leukemia (ALL)—and their parents—are likely to over-report treatment adherence.

In a study of 416 pediatric ALL patients, 84% of patients or their parents said the patients took more 6-mercaptopurine (6MP) than they actually did.

6MP is prescribed for 2 years after chemotherapy with the goal of producing durable remissions, but studies show that over 95% of the prescribed doses must be taken for the medication to be effective.

“Because this therapy is administered orally every day, we cannot supervise our patients to make sure they are taking their pills,” said study author Smita Bhatia, MD, of the University of Alabama at Birmingham.

“Findings from this study suggest that we need better ways to monitor intake of medications as prescribed.”

This study included 416 pediatric ALL patients followed over 4 months. Patients received prescription pill bottles for their 6MP that contained a microprocessor chip in the cap to log the date and time the bottle was opened.

The logs were compared to self-report questionnaires completed by patients or their parents and provided to physicians at monthly check-ups.

Patients were classified as:

• Perfect reporters—self-report corresponded to data from the Medication Event Monitoring System (MEMS)
• Over-reporters—self-report was greater than MEMS data by more than 5 days per month for more than 50% of the study months
• Others—all patients not meeting criteria for perfect- or over-reporter.

Twelve percent of patients were classified as perfect reporters, 23.6% were over-reporters, 0.5% were under-reporters, and 63.9% were classified as “others.”

Self-reported 6MP intake exceeded MEMS data at least some of the time in 84% of patients.

“We observed that there was an inverse relationship between over-reporting and the extent of non-adherence,” Dr Bhatia noted.

Of the patients who adhered to their regimens (defined as taking their prescribed dose 95% of the time), a small percentage (8%) over-reported their intake.

However, among those found to be non-adherent, a substantially larger percent (47%) over-reported.

In order to find out why patients were not taking their prescribed medication, study author Wendy Landier, PhD, RN, also of the University of Alabama at Birmingham, organized interviews with patients and their parents.

In these interviews, Dr Landier noted that forgetfulness was the primary reason for non-adherence.

“We found that partnering with a parent was very conducive to our patients’ adherence, playing a key role in combatting forgetfulness,” she said.

Recognizing the importance of parental involvement in patient adherence, the researchers were inspired to conduct further research to make parents more involved.

In a trial that builds on this study, physicians send personalized text messages to both patients and their parents at a prescribed time reminding them to take their medicine. Both patient and parent then report back, via text, that the indicated dose was taken.

“Our first study showed that non-adherence was prevalent, increasing the risk of relapse,” Dr Bhatia said. “We then found that parental vigilance was an important facilitator to adherence, while forgetting to take the medication was the most commonly reported barrier.”

“We used these findings to inform the intervention trial to help families improve adherence to treatment. We hope that this will be a real step in improving outcomes in children with leukemia.”

Prescription pills

New research published in Blood suggests young patients with acute lymphoblastic leukemia (ALL)—and their parents—are likely to over-report treatment adherence.

In a study of 416 pediatric ALL patients, 84% of patients or their parents said the patients took more 6-mercaptopurine (6MP) than they actually did.

6MP is prescribed for 2 years after chemotherapy with the goal of producing durable remissions, but studies show that over 95% of the prescribed doses must be taken for the medication to be effective.

“Because this therapy is administered orally every day, we cannot supervise our patients to make sure they are taking their pills,” said study author Smita Bhatia, MD, of the University of Alabama at Birmingham.

“Findings from this study suggest that we need better ways to monitor intake of medications as prescribed.”

This study included 416 pediatric ALL patients followed over 4 months. Patients received prescription pill bottles for their 6MP that contained a microprocessor chip in the cap to log the date and time the bottle was opened.

The logs were compared to self-report questionnaires completed by patients or their parents and provided to physicians at monthly check-ups.

Patients were classified as:

• Perfect reporters—self-report corresponded to data from the Medication Event Monitoring System (MEMS)
• Over-reporters—self-report was greater than MEMS data by more than 5 days per month for more than 50% of the study months
• Others—all patients not meeting criteria for perfect- or over-reporter.

Twelve percent of patients were classified as perfect reporters, 23.6% were over-reporters, 0.5% were under-reporters, and 63.9% were classified as “others.”

Self-reported 6MP intake exceeded MEMS data at least some of the time in 84% of patients.

“We observed that there was an inverse relationship between over-reporting and the extent of non-adherence,” Dr Bhatia noted.

Of the patients who adhered to their regimens (defined as taking their prescribed dose 95% of the time), a small percentage (8%) over-reported their intake.

However, among those found to be non-adherent, a substantially larger percent (47%) over-reported.

In order to find out why patients were not taking their prescribed medication, study author Wendy Landier, PhD, RN, also of the University of Alabama at Birmingham, organized interviews with patients and their parents.

In these interviews, Dr Landier noted that forgetfulness was the primary reason for non-adherence.

“We found that partnering with a parent was very conducive to our patients’ adherence, playing a key role in combatting forgetfulness,” she said.

Recognizing the importance of parental involvement in patient adherence, the researchers were inspired to conduct further research to make parents more involved.

In a trial that builds on this study, physicians send personalized text messages to both patients and their parents at a prescribed time reminding them to take their medicine. Both patient and parent then report back, via text, that the indicated dose was taken.

“Our first study showed that non-adherence was prevalent, increasing the risk of relapse,” Dr Bhatia said. “We then found that parental vigilance was an important facilitator to adherence, while forgetting to take the medication was the most commonly reported barrier.”

“We used these findings to inform the intervention trial to help families improve adherence to treatment. We hope that this will be a real step in improving outcomes in children with leukemia.”

Prescription pills

New research published in Blood suggests young patients with acute lymphoblastic leukemia (ALL)—and their parents—are likely to over-report treatment adherence.

In a study of 416 pediatric ALL patients, 84% of patients or their parents said the patients took more 6-mercaptopurine (6MP) than they actually did.

6MP is prescribed for 2 years after chemotherapy with the goal of producing durable remissions, but studies show that over 95% of the prescribed doses must be taken for the medication to be effective.

“Because this therapy is administered orally every day, we cannot supervise our patients to make sure they are taking their pills,” said study author Smita Bhatia, MD, of the University of Alabama at Birmingham.

“Findings from this study suggest that we need better ways to monitor intake of medications as prescribed.”

This study included 416 pediatric ALL patients followed over 4 months. Patients received prescription pill bottles for their 6MP that contained a microprocessor chip in the cap to log the date and time the bottle was opened.

The logs were compared to self-report questionnaires completed by patients or their parents and provided to physicians at monthly check-ups.

Patients were classified as:

• Perfect reporters—self-report corresponded to data from the Medication Event Monitoring System (MEMS)
• Over-reporters—self-report was greater than MEMS data by more than 5 days per month for more than 50% of the study months
• Others—all patients not meeting criteria for perfect- or over-reporter.

Twelve percent of patients were classified as perfect reporters, 23.6% were over-reporters, 0.5% were under-reporters, and 63.9% were classified as “others.”

Self-reported 6MP intake exceeded MEMS data at least some of the time in 84% of patients.

“We observed that there was an inverse relationship between over-reporting and the extent of non-adherence,” Dr Bhatia noted.

Of the patients who adhered to their regimens (defined as taking their prescribed dose 95% of the time), a small percentage (8%) over-reported their intake.

However, among those found to be non-adherent, a substantially larger percent (47%) over-reported.

In order to find out why patients were not taking their prescribed medication, study author Wendy Landier, PhD, RN, also of the University of Alabama at Birmingham, organized interviews with patients and their parents.

In these interviews, Dr Landier noted that forgetfulness was the primary reason for non-adherence.

“We found that partnering with a parent was very conducive to our patients’ adherence, playing a key role in combatting forgetfulness,” she said.

Recognizing the importance of parental involvement in patient adherence, the researchers were inspired to conduct further research to make parents more involved.

In a trial that builds on this study, physicians send personalized text messages to both patients and their parents at a prescribed time reminding them to take their medicine. Both patient and parent then report back, via text, that the indicated dose was taken.

“Our first study showed that non-adherence was prevalent, increasing the risk of relapse,” Dr Bhatia said. “We then found that parental vigilance was an important facilitator to adherence, while forgetting to take the medication was the most commonly reported barrier.”

“We used these findings to inform the intervention trial to help families improve adherence to treatment. We hope that this will be a real step in improving outcomes in children with leukemia.”

The term full practice authority (FPA) means different things to different clinicians. Some think it is a code phrase for “independent practice,” while others regard it as the ability to practice to the fullest extent of their education and licensure. The American Association of Nurse Practitioners (AANP) defines FPA as the “collection of state practice and licensure laws that allow for NPs to evaluate patients, diagnose, order and interpret tests, initiate and manage treatments—including prescribe medications—under the exclusive licensure authority of the state board of nursing.”¹ Whatever the definition, it is an emotionally packed phrase for NPs, PAs, and our physician colleagues.

While NP and PA scope of practice is largely dictated by state laws and regulations, it is also impacted by other factors, including employment agreements, practice setting, and billing requirements of Medicare and other third-party payers.² In the past decade, there has been increasing support for eliminating barriers to practice. Advocates say the current supply of health care services is unnecessarily limited—a problem that will increase as our population ages and people live longer with chronic conditions. With the health care system under constant pressure, many believe that all clinicians should be able to provide care to the full scope of their education and expertise.

Proponents of FPA, including the Institute of Medicine and the National Governors Association, cite improved access to and efficiency of care and reduced costs as the main motivations for lifting practice restrictions.^3,4 In an extensive document, the RAND Corporation called for states to relax scope-of-practice restrictions for NPs.⁵ Findings from the Federal Trade Commission assert that NPs are safe and effective as independent providers of health care services within the scope of their training and licensure.⁶

Meanwhile, opponents—such as the American Academy of Family Physicians (AAFP) and the American Medical Association—express concerns about the lack of clinical education compared to physicians, as well as patient choice and fragmentation of care.⁷ Back in 2010, the AAFP objected to statements from the National Board of Medical Examiners (NBME), which alleged that physicians and nurse clinicians have comparable scopes of practice; NBME further suggested that licensing authorities for both professions “should be required to create common means of assessing proficiency for entry to and continuation in practice.”⁸ Osteopathic physicians pushed back on FPA, worried that NPs would be confused with physicians.⁹ But as NPs have clarified, their license is an extension of their RN license; they do not need physician endorsement for the advanced component.

What goes without saying is that NPs and PAs play a large and expanding role in the American health care delivery system. NPs constitute the fastest-growing segment of the primary care workforce in the United States. And because they are proven to be highly educated clinicians who take responsibility for their clinical decisions, many states are relaxing scope-of-practice restrictions to allow them to provide more extensive services to their patients. Currently, 21 states and the District of Columbia allow FPA for NPs.¹⁰ Furthermore, in a recent landmark decision, the US Department of Veterans Affairs (VA) announced new rules granting Advanced Practice Registered Nurses (APRNs) FPA within the VA system.¹¹

In contrast to the varying degrees of autonomy with which NPs practice, PAs provide medical services exclusively under the delegation of physicians. Although many function in autonomous practices, PAs have no authority to function independently or to provide services unless assigned by and under the auspices of a supervising physician.¹² This should not come as a surprise, since PAs have always touted that the profession was created for physicians, by ­physicians.

But as NPs have advanced their FPA agenda, many PAs have asked, “What about us?” Brian Sady, a PA from Nevada, has been advocating FPA for many years to enhance the accessibility and quality of care in his rural state.¹³

In fact, the American Academy of Physician Assistants has been lobbying the VA to grant FPA to PAs in parity with their recent action regarding NPs.¹⁴ And now, the Academy has gone a step further with the creation of the Joint Task Force on PA Practice Authority. Their raison d’etre is to develop a proposal that supports the elimination of regulations that require PAs to have and/or report supervisory, collaborating, or other specific relationships with a physician in order to practice.¹⁵ This is a significant change of direction for the PA profession and is stimulating a great deal of discussion.

In order to accomplish their goal, the task force must emphasize the PA profession’s continued commitment to team-based practice. Interestingly, Michigan recently enacted a law that distinguishes participating physicians from supervising physicians in order to better reflect the PA and physician roles within the team. The law removes physician responsibility for PA practice, making each member of the health care team responsible for his or her own decisions. It also removes the ratio restriction that limited the number of PAs with whom a physician may practice. By recognizing PAs as full prescribers, rather than limiting their care to “delegated prescriptive authority,” the law grants PAs more autonomy to serve patients.¹⁶

PAs are regulated by the state medical board or a subset of it—only five states have a PA-specific board—whereas NPs have always practiced under the auspices of their state nursing board. If the task force proposals are adopted by the AAPA House of Delegates, they will support the creation of autonomous state boards with a majority of PA members to regulate practice. (Iowa is currently the only state PA board that has a majority of PA members.)

Some argue that FPA for PAs would disrupt the current PA-physician relationship. Others contend that FPA for PAs will strengthen that relationship and balance the respect, support, and professionalism that enable PAs to consistently provide high-quality care.

Both NPs and PAs assert that they have, throughout 50 years, demonstrated a commitment to competent, quality care for patients. By defining the future of our professions, we make our professions more accountable, preserve our positive relationships with physicians and other members of the health care team, decrease unnecessary administrative burdens on physicians and employers, and most importantly, increase access to quality care for our patients. Share your expectations and opinions regarding professional autonomy with me at ­[email protected].

The term full practice authority (FPA) means different things to different clinicians. Some think it is a code phrase for “independent practice,” while others regard it as the ability to practice to the fullest extent of their education and licensure. The American Association of Nurse Practitioners (AANP) defines FPA as the “collection of state practice and licensure laws that allow for NPs to evaluate patients, diagnose, order and interpret tests, initiate and manage treatments—including prescribe medications—under the exclusive licensure authority of the state board of nursing.”¹ Whatever the definition, it is an emotionally packed phrase for NPs, PAs, and our physician colleagues.

While NP and PA scope of practice is largely dictated by state laws and regulations, it is also impacted by other factors, including employment agreements, practice setting, and billing requirements of Medicare and other third-party payers.² In the past decade, there has been increasing support for eliminating barriers to practice. Advocates say the current supply of health care services is unnecessarily limited—a problem that will increase as our population ages and people live longer with chronic conditions. With the health care system under constant pressure, many believe that all clinicians should be able to provide care to the full scope of their education and expertise.

Proponents of FPA, including the Institute of Medicine and the National Governors Association, cite improved access to and efficiency of care and reduced costs as the main motivations for lifting practice restrictions.^3,4 In an extensive document, the RAND Corporation called for states to relax scope-of-practice restrictions for NPs.⁵ Findings from the Federal Trade Commission assert that NPs are safe and effective as independent providers of health care services within the scope of their training and licensure.⁶

Meanwhile, opponents—such as the American Academy of Family Physicians (AAFP) and the American Medical Association—express concerns about the lack of clinical education compared to physicians, as well as patient choice and fragmentation of care.⁷ Back in 2010, the AAFP objected to statements from the National Board of Medical Examiners (NBME), which alleged that physicians and nurse clinicians have comparable scopes of practice; NBME further suggested that licensing authorities for both professions “should be required to create common means of assessing proficiency for entry to and continuation in practice.”⁸ Osteopathic physicians pushed back on FPA, worried that NPs would be confused with physicians.⁹ But as NPs have clarified, their license is an extension of their RN license; they do not need physician endorsement for the advanced component.

What goes without saying is that NPs and PAs play a large and expanding role in the American health care delivery system. NPs constitute the fastest-growing segment of the primary care workforce in the United States. And because they are proven to be highly educated clinicians who take responsibility for their clinical decisions, many states are relaxing scope-of-practice restrictions to allow them to provide more extensive services to their patients. Currently, 21 states and the District of Columbia allow FPA for NPs.¹⁰ Furthermore, in a recent landmark decision, the US Department of Veterans Affairs (VA) announced new rules granting Advanced Practice Registered Nurses (APRNs) FPA within the VA system.¹¹

In contrast to the varying degrees of autonomy with which NPs practice, PAs provide medical services exclusively under the delegation of physicians. Although many function in autonomous practices, PAs have no authority to function independently or to provide services unless assigned by and under the auspices of a supervising physician.¹² This should not come as a surprise, since PAs have always touted that the profession was created for physicians, by ­physicians.

But as NPs have advanced their FPA agenda, many PAs have asked, “What about us?” Brian Sady, a PA from Nevada, has been advocating FPA for many years to enhance the accessibility and quality of care in his rural state.¹³

In fact, the American Academy of Physician Assistants has been lobbying the VA to grant FPA to PAs in parity with their recent action regarding NPs.¹⁴ And now, the Academy has gone a step further with the creation of the Joint Task Force on PA Practice Authority. Their raison d’etre is to develop a proposal that supports the elimination of regulations that require PAs to have and/or report supervisory, collaborating, or other specific relationships with a physician in order to practice.¹⁵ This is a significant change of direction for the PA profession and is stimulating a great deal of discussion.

In order to accomplish their goal, the task force must emphasize the PA profession’s continued commitment to team-based practice. Interestingly, Michigan recently enacted a law that distinguishes participating physicians from supervising physicians in order to better reflect the PA and physician roles within the team. The law removes physician responsibility for PA practice, making each member of the health care team responsible for his or her own decisions. It also removes the ratio restriction that limited the number of PAs with whom a physician may practice. By recognizing PAs as full prescribers, rather than limiting their care to “delegated prescriptive authority,” the law grants PAs more autonomy to serve patients.¹⁶

PAs are regulated by the state medical board or a subset of it—only five states have a PA-specific board—whereas NPs have always practiced under the auspices of their state nursing board. If the task force proposals are adopted by the AAPA House of Delegates, they will support the creation of autonomous state boards with a majority of PA members to regulate practice. (Iowa is currently the only state PA board that has a majority of PA members.)

Some argue that FPA for PAs would disrupt the current PA-physician relationship. Others contend that FPA for PAs will strengthen that relationship and balance the respect, support, and professionalism that enable PAs to consistently provide high-quality care.

Both NPs and PAs assert that they have, throughout 50 years, demonstrated a commitment to competent, quality care for patients. By defining the future of our professions, we make our professions more accountable, preserve our positive relationships with physicians and other members of the health care team, decrease unnecessary administrative burdens on physicians and employers, and most importantly, increase access to quality care for our patients. Share your expectations and opinions regarding professional autonomy with me at ­[email protected].

The term full practice authority (FPA) means different things to different clinicians. Some think it is a code phrase for “independent practice,” while others regard it as the ability to practice to the fullest extent of their education and licensure. The American Association of Nurse Practitioners (AANP) defines FPA as the “collection of state practice and licensure laws that allow for NPs to evaluate patients, diagnose, order and interpret tests, initiate and manage treatments—including prescribe medications—under the exclusive licensure authority of the state board of nursing.”¹ Whatever the definition, it is an emotionally packed phrase for NPs, PAs, and our physician colleagues.

While NP and PA scope of practice is largely dictated by state laws and regulations, it is also impacted by other factors, including employment agreements, practice setting, and billing requirements of Medicare and other third-party payers.² In the past decade, there has been increasing support for eliminating barriers to practice. Advocates say the current supply of health care services is unnecessarily limited—a problem that will increase as our population ages and people live longer with chronic conditions. With the health care system under constant pressure, many believe that all clinicians should be able to provide care to the full scope of their education and expertise.

Proponents of FPA, including the Institute of Medicine and the National Governors Association, cite improved access to and efficiency of care and reduced costs as the main motivations for lifting practice restrictions.^3,4 In an extensive document, the RAND Corporation called for states to relax scope-of-practice restrictions for NPs.⁵ Findings from the Federal Trade Commission assert that NPs are safe and effective as independent providers of health care services within the scope of their training and licensure.⁶

Meanwhile, opponents—such as the American Academy of Family Physicians (AAFP) and the American Medical Association—express concerns about the lack of clinical education compared to physicians, as well as patient choice and fragmentation of care.⁷ Back in 2010, the AAFP objected to statements from the National Board of Medical Examiners (NBME), which alleged that physicians and nurse clinicians have comparable scopes of practice; NBME further suggested that licensing authorities for both professions “should be required to create common means of assessing proficiency for entry to and continuation in practice.”⁸ Osteopathic physicians pushed back on FPA, worried that NPs would be confused with physicians.⁹ But as NPs have clarified, their license is an extension of their RN license; they do not need physician endorsement for the advanced component.

What goes without saying is that NPs and PAs play a large and expanding role in the American health care delivery system. NPs constitute the fastest-growing segment of the primary care workforce in the United States. And because they are proven to be highly educated clinicians who take responsibility for their clinical decisions, many states are relaxing scope-of-practice restrictions to allow them to provide more extensive services to their patients. Currently, 21 states and the District of Columbia allow FPA for NPs.¹⁰ Furthermore, in a recent landmark decision, the US Department of Veterans Affairs (VA) announced new rules granting Advanced Practice Registered Nurses (APRNs) FPA within the VA system.¹¹

In contrast to the varying degrees of autonomy with which NPs practice, PAs provide medical services exclusively under the delegation of physicians. Although many function in autonomous practices, PAs have no authority to function independently or to provide services unless assigned by and under the auspices of a supervising physician.¹² This should not come as a surprise, since PAs have always touted that the profession was created for physicians, by ­physicians.

But as NPs have advanced their FPA agenda, many PAs have asked, “What about us?” Brian Sady, a PA from Nevada, has been advocating FPA for many years to enhance the accessibility and quality of care in his rural state.¹³

In fact, the American Academy of Physician Assistants has been lobbying the VA to grant FPA to PAs in parity with their recent action regarding NPs.¹⁴ And now, the Academy has gone a step further with the creation of the Joint Task Force on PA Practice Authority. Their raison d’etre is to develop a proposal that supports the elimination of regulations that require PAs to have and/or report supervisory, collaborating, or other specific relationships with a physician in order to practice.¹⁵ This is a significant change of direction for the PA profession and is stimulating a great deal of discussion.

In order to accomplish their goal, the task force must emphasize the PA profession’s continued commitment to team-based practice. Interestingly, Michigan recently enacted a law that distinguishes participating physicians from supervising physicians in order to better reflect the PA and physician roles within the team. The law removes physician responsibility for PA practice, making each member of the health care team responsible for his or her own decisions. It also removes the ratio restriction that limited the number of PAs with whom a physician may practice. By recognizing PAs as full prescribers, rather than limiting their care to “delegated prescriptive authority,” the law grants PAs more autonomy to serve patients.¹⁶

PAs are regulated by the state medical board or a subset of it—only five states have a PA-specific board—whereas NPs have always practiced under the auspices of their state nursing board. If the task force proposals are adopted by the AAPA House of Delegates, they will support the creation of autonomous state boards with a majority of PA members to regulate practice. (Iowa is currently the only state PA board that has a majority of PA members.)

Some argue that FPA for PAs would disrupt the current PA-physician relationship. Others contend that FPA for PAs will strengthen that relationship and balance the respect, support, and professionalism that enable PAs to consistently provide high-quality care.

Both NPs and PAs assert that they have, throughout 50 years, demonstrated a commitment to competent, quality care for patients. By defining the future of our professions, we make our professions more accountable, preserve our positive relationships with physicians and other members of the health care team, decrease unnecessary administrative burdens on physicians and employers, and most importantly, increase access to quality care for our patients. Share your expectations and opinions regarding professional autonomy with me at ­[email protected].

Veterans are 40% more likely than nonveterans to experience severe pain, according to the 2010-2014 National Health Interview Survey. Epidemiologists from the National Center for Complementary and Integrative Health analyzed data on 6,647 veterans and 61,049 nonveterans who were asked about the persistence and intensity of self-reported pain during the previous 3 months.

Veterans were more likely to report having pain (65.5% vs 56.4%) and more likely to describe severe pain—that is, pain that occurred “most days” or “every day” and bothered the respondent “a lot” (9.1% vs 6.3%). Younger veterans in particular were more than 2 times as likely to report severe pain (7.8% vs 3.2%), even when researchers controlled for underlying demographic characteristics. Veterans aged 18 to 39 years and 50 to 59 years were more likely than nonveterans of the same ages to have any pain, but veterans aged ≥ 70 years were less likely to have severe pain than were similarly aged nonveterans.

Back pain and joint pain topped the list for veterans compared with jaw pain and migraines for nonveterans.

The majority of veteran participants were men (92.5%), whereas the majority of nonveteran participants were women (56.5%). The survey data did not identify any specific aspects of military service, including branch of the armed forces, years of service, or whether the veteran served in a combat role.

The survey also didn’t collect information on pain treatment, so it isn’t clear whether differences in treatment would explain the differences in pain experiences. Nor did the survey reveal whether younger veterans with severe pain were in pain despite treatment or because they weren’t getting any treatment.

 “These findings suggest that more attention should be paid to helping veterans manage the impact of severe pain and related disability on daily activities,” the lead researcher said.

Veterans are 40% more likely than nonveterans to experience severe pain, according to the 2010-2014 National Health Interview Survey. Epidemiologists from the National Center for Complementary and Integrative Health analyzed data on 6,647 veterans and 61,049 nonveterans who were asked about the persistence and intensity of self-reported pain during the previous 3 months.

Veterans were more likely to report having pain (65.5% vs 56.4%) and more likely to describe severe pain—that is, pain that occurred “most days” or “every day” and bothered the respondent “a lot” (9.1% vs 6.3%). Younger veterans in particular were more than 2 times as likely to report severe pain (7.8% vs 3.2%), even when researchers controlled for underlying demographic characteristics. Veterans aged 18 to 39 years and 50 to 59 years were more likely than nonveterans of the same ages to have any pain, but veterans aged ≥ 70 years were less likely to have severe pain than were similarly aged nonveterans.

Back pain and joint pain topped the list for veterans compared with jaw pain and migraines for nonveterans.

The majority of veteran participants were men (92.5%), whereas the majority of nonveteran participants were women (56.5%). The survey data did not identify any specific aspects of military service, including branch of the armed forces, years of service, or whether the veteran served in a combat role.

The survey also didn’t collect information on pain treatment, so it isn’t clear whether differences in treatment would explain the differences in pain experiences. Nor did the survey reveal whether younger veterans with severe pain were in pain despite treatment or because they weren’t getting any treatment.

 “These findings suggest that more attention should be paid to helping veterans manage the impact of severe pain and related disability on daily activities,” the lead researcher said.

Veterans are 40% more likely than nonveterans to experience severe pain, according to the 2010-2014 National Health Interview Survey. Epidemiologists from the National Center for Complementary and Integrative Health analyzed data on 6,647 veterans and 61,049 nonveterans who were asked about the persistence and intensity of self-reported pain during the previous 3 months.

Veterans were more likely to report having pain (65.5% vs 56.4%) and more likely to describe severe pain—that is, pain that occurred “most days” or “every day” and bothered the respondent “a lot” (9.1% vs 6.3%). Younger veterans in particular were more than 2 times as likely to report severe pain (7.8% vs 3.2%), even when researchers controlled for underlying demographic characteristics. Veterans aged 18 to 39 years and 50 to 59 years were more likely than nonveterans of the same ages to have any pain, but veterans aged ≥ 70 years were less likely to have severe pain than were similarly aged nonveterans.

Back pain and joint pain topped the list for veterans compared with jaw pain and migraines for nonveterans.

The majority of veteran participants were men (92.5%), whereas the majority of nonveteran participants were women (56.5%). The survey data did not identify any specific aspects of military service, including branch of the armed forces, years of service, or whether the veteran served in a combat role.

The survey also didn’t collect information on pain treatment, so it isn’t clear whether differences in treatment would explain the differences in pain experiences. Nor did the survey reveal whether younger veterans with severe pain were in pain despite treatment or because they weren’t getting any treatment.

 “These findings suggest that more attention should be paid to helping veterans manage the impact of severe pain and related disability on daily activities,” the lead researcher said.

MIAMI – Pinch grafting can accelerate the healing of chronic, treatment-resistant wounds such as leg ulcers, while at the same time reducing morbidity to the donor skin site. A new epidermal harvesting device also is showing promise, as is a new tool that minces autologous skin grafts prior to application to promote wound healing.

These and other advances in wound healing were presented at the Orlando Dermatology Aesthetic and Clinical Conference. The pinch grafts and minced grafts each rely on the newly added skin to stimulate cytokines. Interestingly, there is evidence that grafts taken from hair-bearing donor sites could be superior for stimulating cytokines and accelerating wound healing, said Robert Kirsner, MD, PhD, of the University of Miami Health System.
 

Islands of regrowth

Physicians perform pinch grafting by taking small punches of skin from a donor site on the thigh, abdomen, or elsewhere, and then transferring the grafts to serve as islands of regrowth in a wound. Pinch grafting can be faster and less expensive than techniques typically performed in an operating room, such as meshed auto-grafting. In contrast, pinch grafting can be accomplished in an office setting “and patients can do quite well.” Dr. Kirsner said. In terms of outcomes, “our data is typical,” he added. “About 50% of refractory ulcers heal, 25% improve, and a percentage recur.”

Spreadable skin grafts

Another autologous grafting technique that can be performed at the bedside uses the Xpansion Micro-Autografting Kit, which minces autologous, split thickness skin grafts. “Then you apply them like peanut butter to bread,” Dr. Kirsner said.

The micro-autografts can help heal both acute and chronic wounds, including full thickness wounds from trauma, some burn wounds, diabetic foot ulcers, and venous ulcers, according to the manufacturer’s website.
 

Epidermal harvesting (without anesthesia)

Epidermal grafting can make sense because the epidermis regenerates. “You can lift off just the epidermis with heat or suction, “ Dr. Kirsner said. For the first time, he added, a new tool allows epidermal grafting without the need for anesthesia (Cellutome Epidermal Harvesting System). The device raises little microdomes of epidermis down to the basal layer, including basal keratinocytes and melanocytes, and a dermatologist can use a sterile dressing to transfer them to the wound. Confocal microscopy shows the dermoepidermal junction healing as early as within 2 days.

The epidermal harvesting was initially developed for pigment problems, such as piebaldism. (Dermatol Surg. 2017 Jan;43[1]:159-60). “We quickly realized it might have applicability for nonhealing wounds,” Dr. Kirsner said.

Deeper wound healing

A novel strategy for triggering deeper wound healing evolved from fractional laser technology, which remove columns of skin to generate healing. Instead, Rox Anderson, MD, of Massachusetts General Hospital, Boston, “envisioned pulling up microcolumns of full thickness epidermis, all the way to the fat, placing them into a wound, and the wound would heal with very little donor site morbidity,” Dr. Kirsner said.

This tool is coming out in spring of this year, he noted. It will resemble a fractional laser, “but now you have the skin available to place in another wound.” Prior animal studies revealed a healing benefit with very little scarring, he added.
 

Is hairier better?

Does the donor site matter? Dr. Kirsner asked. Although dermatologists typically graft skin from an abdomen or thigh, a hair-bearing site may be a better option because of the presence of pluripotent stem cells, according to a case report (Wounds. 2016 Apr;28[4]:109-11). J.D. Fox of the University of Miami, Dr. Kirsner, and their colleagues treated a large, chronic venous leg ulcer, almost 60 cm², with punch grafts from a variety of donor sites.

“The side that got scalp punch grafts healed better, suggesting with skin taken from richly hairy area, you’ll get better results,” Dr. Kirsner said.

Another study supports this strategy (J Am Acad Dermatol. 2016 Nov;75[5]:1007-14). These researchers reported greater wound size reduction using grafts containing hair follicles versus nonhairy areas, again suggesting follicular stem cells play a role in better wound healing, Dr. Kirsner said. “This may be a better source of donor skin in the future.”

Dr. Kirsner is a consultant for Cardinal Health, Mölnlycke, Amniox, Organogenesis, Kerecis, Keretec, and KCI, an Acelity company.

MIAMI – Pinch grafting can accelerate the healing of chronic, treatment-resistant wounds such as leg ulcers, while at the same time reducing morbidity to the donor skin site. A new epidermal harvesting device also is showing promise, as is a new tool that minces autologous skin grafts prior to application to promote wound healing.

These and other advances in wound healing were presented at the Orlando Dermatology Aesthetic and Clinical Conference. The pinch grafts and minced grafts each rely on the newly added skin to stimulate cytokines. Interestingly, there is evidence that grafts taken from hair-bearing donor sites could be superior for stimulating cytokines and accelerating wound healing, said Robert Kirsner, MD, PhD, of the University of Miami Health System.
 

Islands of regrowth

Physicians perform pinch grafting by taking small punches of skin from a donor site on the thigh, abdomen, or elsewhere, and then transferring the grafts to serve as islands of regrowth in a wound. Pinch grafting can be faster and less expensive than techniques typically performed in an operating room, such as meshed auto-grafting. In contrast, pinch grafting can be accomplished in an office setting “and patients can do quite well.” Dr. Kirsner said. In terms of outcomes, “our data is typical,” he added. “About 50% of refractory ulcers heal, 25% improve, and a percentage recur.”

Spreadable skin grafts

Another autologous grafting technique that can be performed at the bedside uses the Xpansion Micro-Autografting Kit, which minces autologous, split thickness skin grafts. “Then you apply them like peanut butter to bread,” Dr. Kirsner said.

The micro-autografts can help heal both acute and chronic wounds, including full thickness wounds from trauma, some burn wounds, diabetic foot ulcers, and venous ulcers, according to the manufacturer’s website.
 

Epidermal harvesting (without anesthesia)

Epidermal grafting can make sense because the epidermis regenerates. “You can lift off just the epidermis with heat or suction, “ Dr. Kirsner said. For the first time, he added, a new tool allows epidermal grafting without the need for anesthesia (Cellutome Epidermal Harvesting System). The device raises little microdomes of epidermis down to the basal layer, including basal keratinocytes and melanocytes, and a dermatologist can use a sterile dressing to transfer them to the wound. Confocal microscopy shows the dermoepidermal junction healing as early as within 2 days.

The epidermal harvesting was initially developed for pigment problems, such as piebaldism. (Dermatol Surg. 2017 Jan;43[1]:159-60). “We quickly realized it might have applicability for nonhealing wounds,” Dr. Kirsner said.

Deeper wound healing

A novel strategy for triggering deeper wound healing evolved from fractional laser technology, which remove columns of skin to generate healing. Instead, Rox Anderson, MD, of Massachusetts General Hospital, Boston, “envisioned pulling up microcolumns of full thickness epidermis, all the way to the fat, placing them into a wound, and the wound would heal with very little donor site morbidity,” Dr. Kirsner said.

This tool is coming out in spring of this year, he noted. It will resemble a fractional laser, “but now you have the skin available to place in another wound.” Prior animal studies revealed a healing benefit with very little scarring, he added.
 

Is hairier better?

Does the donor site matter? Dr. Kirsner asked. Although dermatologists typically graft skin from an abdomen or thigh, a hair-bearing site may be a better option because of the presence of pluripotent stem cells, according to a case report (Wounds. 2016 Apr;28[4]:109-11). J.D. Fox of the University of Miami, Dr. Kirsner, and their colleagues treated a large, chronic venous leg ulcer, almost 60 cm², with punch grafts from a variety of donor sites.

“The side that got scalp punch grafts healed better, suggesting with skin taken from richly hairy area, you’ll get better results,” Dr. Kirsner said.

Another study supports this strategy (J Am Acad Dermatol. 2016 Nov;75[5]:1007-14). These researchers reported greater wound size reduction using grafts containing hair follicles versus nonhairy areas, again suggesting follicular stem cells play a role in better wound healing, Dr. Kirsner said. “This may be a better source of donor skin in the future.”

Dr. Kirsner is a consultant for Cardinal Health, Mölnlycke, Amniox, Organogenesis, Kerecis, Keretec, and KCI, an Acelity company.

MIAMI – Pinch grafting can accelerate the healing of chronic, treatment-resistant wounds such as leg ulcers, while at the same time reducing morbidity to the donor skin site. A new epidermal harvesting device also is showing promise, as is a new tool that minces autologous skin grafts prior to application to promote wound healing.

These and other advances in wound healing were presented at the Orlando Dermatology Aesthetic and Clinical Conference. The pinch grafts and minced grafts each rely on the newly added skin to stimulate cytokines. Interestingly, there is evidence that grafts taken from hair-bearing donor sites could be superior for stimulating cytokines and accelerating wound healing, said Robert Kirsner, MD, PhD, of the University of Miami Health System.
 

Islands of regrowth

Physicians perform pinch grafting by taking small punches of skin from a donor site on the thigh, abdomen, or elsewhere, and then transferring the grafts to serve as islands of regrowth in a wound. Pinch grafting can be faster and less expensive than techniques typically performed in an operating room, such as meshed auto-grafting. In contrast, pinch grafting can be accomplished in an office setting “and patients can do quite well.” Dr. Kirsner said. In terms of outcomes, “our data is typical,” he added. “About 50% of refractory ulcers heal, 25% improve, and a percentage recur.”

Spreadable skin grafts

Another autologous grafting technique that can be performed at the bedside uses the Xpansion Micro-Autografting Kit, which minces autologous, split thickness skin grafts. “Then you apply them like peanut butter to bread,” Dr. Kirsner said.

The micro-autografts can help heal both acute and chronic wounds, including full thickness wounds from trauma, some burn wounds, diabetic foot ulcers, and venous ulcers, according to the manufacturer’s website.
 

Epidermal harvesting (without anesthesia)

Epidermal grafting can make sense because the epidermis regenerates. “You can lift off just the epidermis with heat or suction, “ Dr. Kirsner said. For the first time, he added, a new tool allows epidermal grafting without the need for anesthesia (Cellutome Epidermal Harvesting System). The device raises little microdomes of epidermis down to the basal layer, including basal keratinocytes and melanocytes, and a dermatologist can use a sterile dressing to transfer them to the wound. Confocal microscopy shows the dermoepidermal junction healing as early as within 2 days.

The epidermal harvesting was initially developed for pigment problems, such as piebaldism. (Dermatol Surg. 2017 Jan;43[1]:159-60). “We quickly realized it might have applicability for nonhealing wounds,” Dr. Kirsner said.

Deeper wound healing

A novel strategy for triggering deeper wound healing evolved from fractional laser technology, which remove columns of skin to generate healing. Instead, Rox Anderson, MD, of Massachusetts General Hospital, Boston, “envisioned pulling up microcolumns of full thickness epidermis, all the way to the fat, placing them into a wound, and the wound would heal with very little donor site morbidity,” Dr. Kirsner said.

This tool is coming out in spring of this year, he noted. It will resemble a fractional laser, “but now you have the skin available to place in another wound.” Prior animal studies revealed a healing benefit with very little scarring, he added.
 

Is hairier better?

Does the donor site matter? Dr. Kirsner asked. Although dermatologists typically graft skin from an abdomen or thigh, a hair-bearing site may be a better option because of the presence of pluripotent stem cells, according to a case report (Wounds. 2016 Apr;28[4]:109-11). J.D. Fox of the University of Miami, Dr. Kirsner, and their colleagues treated a large, chronic venous leg ulcer, almost 60 cm², with punch grafts from a variety of donor sites.

“The side that got scalp punch grafts healed better, suggesting with skin taken from richly hairy area, you’ll get better results,” Dr. Kirsner said.

Another study supports this strategy (J Am Acad Dermatol. 2016 Nov;75[5]:1007-14). These researchers reported greater wound size reduction using grafts containing hair follicles versus nonhairy areas, again suggesting follicular stem cells play a role in better wound healing, Dr. Kirsner said. “This may be a better source of donor skin in the future.”

Dr. Kirsner is a consultant for Cardinal Health, Mölnlycke, Amniox, Organogenesis, Kerecis, Keretec, and KCI, an Acelity company.

The immigration ban from seven Muslim-majority countries issued recently by the Trump administration is having the unintended effect of disrupting scientific collaboration, according to a statement issued by the Endocrine Society.

“President Donald Trump’s order instituting a temporary travel ban from certain countries will greatly impact knowledge sharing among doctors and researchers and ultimately adversely affect patient care, Henry M. Kronenberg, MD, Endocrine Society president, wrote in a press release. “Science, at its core, is a global endeavor.”

Gary D. Hammer, MD, PhD, program chair of this year’s meeting, which is scheduled to take place April 1-4 in Orlando, said in an interview that he had received an email from a colleague in Iran, one of the seven targeted countries, immediately after imposition of the temporary travel ban. That endocrinologist, along with his fellow Iranian colleagues, had airline tickets and hotel rooms, and had invested in meeting fees and other upfront expenses, leaving them all with the question of what to do now. “He was prepared to come but now can’t due to the travel ban,” said Dr. Hammer, Millie Schembechler Professor of Adrenal Cancer at the University of Michigan in Ann Arbor, Mich. That email was the start of the Endocrine Society’s early action to address the ban, he noted. “I relayed the concern to Dr. Kronenberg and associated society leadership, who agreed that this is a pressing issue that must be addressed immediately,” Dr. Hammer said.

Another colleague, a woman from Sudan now living in the Netherlands on a visa, is, concerned too, that she would be turned away because her passport is issued by Sudan. She will not be attending the meeting, either. And another colleague not a citizen of one of the seven countries or even a western European descendant of relatives from there, called to say he would not be coming because of concern about the “increased challenge” of trying to enter the United States from Europe. “The ripple effect of this executive action has instilled fear across the globe, regardless of where they live,” Dr. Hammer said of clinical endocrinologists and endocrine scientists reluctant to come to the Endocrine Society’s annual meeting.

“The Endocrine Society is a global organization with 18,000 members in 122 countries, including some singled out by the travel ban,” the press release said. In fact, 40% of members of the Endocrine Society live outside the United States, a fact that underscores the collaborative nature of scientific research, clinical advances, and education in endocrinology.
In Dr. Hammer’s own area of expertise – endocrine cancers – advances in research and clinical management are made only when scientists come from around the world to pool their rare genetic resources and experience to make breakthroughs. “It often takes decades to develop international collaborations,” he said. Some endocrine cancers and other endocrine diseases are quite rare. Relying on cases just in the United States would make it less likely that there would be therapeutic advances, he said.

“Clinical care advances only through the application of science, and this effort is inherently global,” Dr. Hammer stressed.

[email protected]

The immigration ban from seven Muslim-majority countries issued recently by the Trump administration is having the unintended effect of disrupting scientific collaboration, according to a statement issued by the Endocrine Society.

“President Donald Trump’s order instituting a temporary travel ban from certain countries will greatly impact knowledge sharing among doctors and researchers and ultimately adversely affect patient care, Henry M. Kronenberg, MD, Endocrine Society president, wrote in a press release. “Science, at its core, is a global endeavor.”

Gary D. Hammer, MD, PhD, program chair of this year’s meeting, which is scheduled to take place April 1-4 in Orlando, said in an interview that he had received an email from a colleague in Iran, one of the seven targeted countries, immediately after imposition of the temporary travel ban. That endocrinologist, along with his fellow Iranian colleagues, had airline tickets and hotel rooms, and had invested in meeting fees and other upfront expenses, leaving them all with the question of what to do now. “He was prepared to come but now can’t due to the travel ban,” said Dr. Hammer, Millie Schembechler Professor of Adrenal Cancer at the University of Michigan in Ann Arbor, Mich. That email was the start of the Endocrine Society’s early action to address the ban, he noted. “I relayed the concern to Dr. Kronenberg and associated society leadership, who agreed that this is a pressing issue that must be addressed immediately,” Dr. Hammer said.

Another colleague, a woman from Sudan now living in the Netherlands on a visa, is, concerned too, that she would be turned away because her passport is issued by Sudan. She will not be attending the meeting, either. And another colleague not a citizen of one of the seven countries or even a western European descendant of relatives from there, called to say he would not be coming because of concern about the “increased challenge” of trying to enter the United States from Europe. “The ripple effect of this executive action has instilled fear across the globe, regardless of where they live,” Dr. Hammer said of clinical endocrinologists and endocrine scientists reluctant to come to the Endocrine Society’s annual meeting.

“The Endocrine Society is a global organization with 18,000 members in 122 countries, including some singled out by the travel ban,” the press release said. In fact, 40% of members of the Endocrine Society live outside the United States, a fact that underscores the collaborative nature of scientific research, clinical advances, and education in endocrinology.
In Dr. Hammer’s own area of expertise – endocrine cancers – advances in research and clinical management are made only when scientists come from around the world to pool their rare genetic resources and experience to make breakthroughs. “It often takes decades to develop international collaborations,” he said. Some endocrine cancers and other endocrine diseases are quite rare. Relying on cases just in the United States would make it less likely that there would be therapeutic advances, he said.

“Clinical care advances only through the application of science, and this effort is inherently global,” Dr. Hammer stressed.

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The immigration ban from seven Muslim-majority countries issued recently by the Trump administration is having the unintended effect of disrupting scientific collaboration, according to a statement issued by the Endocrine Society.

“President Donald Trump’s order instituting a temporary travel ban from certain countries will greatly impact knowledge sharing among doctors and researchers and ultimately adversely affect patient care, Henry M. Kronenberg, MD, Endocrine Society president, wrote in a press release. “Science, at its core, is a global endeavor.”

Gary D. Hammer, MD, PhD, program chair of this year’s meeting, which is scheduled to take place April 1-4 in Orlando, said in an interview that he had received an email from a colleague in Iran, one of the seven targeted countries, immediately after imposition of the temporary travel ban. That endocrinologist, along with his fellow Iranian colleagues, had airline tickets and hotel rooms, and had invested in meeting fees and other upfront expenses, leaving them all with the question of what to do now. “He was prepared to come but now can’t due to the travel ban,” said Dr. Hammer, Millie Schembechler Professor of Adrenal Cancer at the University of Michigan in Ann Arbor, Mich. That email was the start of the Endocrine Society’s early action to address the ban, he noted. “I relayed the concern to Dr. Kronenberg and associated society leadership, who agreed that this is a pressing issue that must be addressed immediately,” Dr. Hammer said.

Another colleague, a woman from Sudan now living in the Netherlands on a visa, is, concerned too, that she would be turned away because her passport is issued by Sudan. She will not be attending the meeting, either. And another colleague not a citizen of one of the seven countries or even a western European descendant of relatives from there, called to say he would not be coming because of concern about the “increased challenge” of trying to enter the United States from Europe. “The ripple effect of this executive action has instilled fear across the globe, regardless of where they live,” Dr. Hammer said of clinical endocrinologists and endocrine scientists reluctant to come to the Endocrine Society’s annual meeting.

“The Endocrine Society is a global organization with 18,000 members in 122 countries, including some singled out by the travel ban,” the press release said. In fact, 40% of members of the Endocrine Society live outside the United States, a fact that underscores the collaborative nature of scientific research, clinical advances, and education in endocrinology.
In Dr. Hammer’s own area of expertise – endocrine cancers – advances in research and clinical management are made only when scientists come from around the world to pool their rare genetic resources and experience to make breakthroughs. “It often takes decades to develop international collaborations,” he said. Some endocrine cancers and other endocrine diseases are quite rare. Relying on cases just in the United States would make it less likely that there would be therapeutic advances, he said.

“Clinical care advances only through the application of science, and this effort is inherently global,” Dr. Hammer stressed.

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Unhealthy eating behaviors could be a risk factor for the development of depressive symptoms, new research suggests.

“This prospective study is the first to reveal the combined relationship between unhealthy eating and the incidence of depressive symptoms,” wrote Cong Huang, PhD, and his coauthors. “In contrast to previous studies, in which the focus of research has been on the impact of depressive symptoms on eating habits, we considered depressive symptoms to be a consequence of these unhealthy behaviors. Taken together, these findings reveal the possibility of a vicious cycle between unhealthy eating habits and mental health problems,” wrote Dr. Huang of Tohoku University in Sendai, Japan.

Dr. Huang and coauthors recruited 376 Japanese adults aged 24-38 over a 2-year period. Three hundred of the participants were men, and none had depressive symptoms at baseline (J Epidemiol. 2017;27[1]:42-7).

The participants were asked to answer three questions aimed at assessing their eating habits. Eating behaviors that were deemed unhealthy included skipping breakfast at least three times per week, eating dinner within 2 hours of going to bed, and eating snacks after dinner more than three times per week. Meanwhile, the participants’ depressive symptoms were measured at baseline and follow-up using the Japanese version of the Zung Self-Rating Depression Scale.

The investigators found that skipping breakfast appeared tied to a higher prevalence of depressive symptoms (P = .026). They also found a prospective relationship between eating snacks after dinner and depressive symptoms (relative risk, 1.77; 95% confidence interval, 1.00-3.14). Interestingly, the relationship between snacking after dinner and depressive symptoms “was limited to those who had [the] habit of having dinner shortly before bedtime (P for the interaction = .044),” they wrote.

In light of these findings, improving eating habits could have an impact on depressive disorders, Dr. Huang and coauthors said. Read the full study here.

[email protected]

On Twitter @ginalhenderson

Unhealthy eating behaviors could be a risk factor for the development of depressive symptoms, new research suggests.

“This prospective study is the first to reveal the combined relationship between unhealthy eating and the incidence of depressive symptoms,” wrote Cong Huang, PhD, and his coauthors. “In contrast to previous studies, in which the focus of research has been on the impact of depressive symptoms on eating habits, we considered depressive symptoms to be a consequence of these unhealthy behaviors. Taken together, these findings reveal the possibility of a vicious cycle between unhealthy eating habits and mental health problems,” wrote Dr. Huang of Tohoku University in Sendai, Japan.

Dr. Huang and coauthors recruited 376 Japanese adults aged 24-38 over a 2-year period. Three hundred of the participants were men, and none had depressive symptoms at baseline (J Epidemiol. 2017;27[1]:42-7).

The participants were asked to answer three questions aimed at assessing their eating habits. Eating behaviors that were deemed unhealthy included skipping breakfast at least three times per week, eating dinner within 2 hours of going to bed, and eating snacks after dinner more than three times per week. Meanwhile, the participants’ depressive symptoms were measured at baseline and follow-up using the Japanese version of the Zung Self-Rating Depression Scale.

The investigators found that skipping breakfast appeared tied to a higher prevalence of depressive symptoms (P = .026). They also found a prospective relationship between eating snacks after dinner and depressive symptoms (relative risk, 1.77; 95% confidence interval, 1.00-3.14). Interestingly, the relationship between snacking after dinner and depressive symptoms “was limited to those who had [the] habit of having dinner shortly before bedtime (P for the interaction = .044),” they wrote.

In light of these findings, improving eating habits could have an impact on depressive disorders, Dr. Huang and coauthors said. Read the full study here.

[email protected]

On Twitter @ginalhenderson

Unhealthy eating behaviors could be a risk factor for the development of depressive symptoms, new research suggests.

“This prospective study is the first to reveal the combined relationship between unhealthy eating and the incidence of depressive symptoms,” wrote Cong Huang, PhD, and his coauthors. “In contrast to previous studies, in which the focus of research has been on the impact of depressive symptoms on eating habits, we considered depressive symptoms to be a consequence of these unhealthy behaviors. Taken together, these findings reveal the possibility of a vicious cycle between unhealthy eating habits and mental health problems,” wrote Dr. Huang of Tohoku University in Sendai, Japan.

Dr. Huang and coauthors recruited 376 Japanese adults aged 24-38 over a 2-year period. Three hundred of the participants were men, and none had depressive symptoms at baseline (J Epidemiol. 2017;27[1]:42-7).

The participants were asked to answer three questions aimed at assessing their eating habits. Eating behaviors that were deemed unhealthy included skipping breakfast at least three times per week, eating dinner within 2 hours of going to bed, and eating snacks after dinner more than three times per week. Meanwhile, the participants’ depressive symptoms were measured at baseline and follow-up using the Japanese version of the Zung Self-Rating Depression Scale.

The investigators found that skipping breakfast appeared tied to a higher prevalence of depressive symptoms (P = .026). They also found a prospective relationship between eating snacks after dinner and depressive symptoms (relative risk, 1.77; 95% confidence interval, 1.00-3.14). Interestingly, the relationship between snacking after dinner and depressive symptoms “was limited to those who had [the] habit of having dinner shortly before bedtime (P for the interaction = .044),” they wrote.

In light of these findings, improving eating habits could have an impact on depressive disorders, Dr. Huang and coauthors said. Read the full study here.

[email protected]

On Twitter @ginalhenderson

ORLANDO – New European Society of Cardiology management guidelines encourage electrocardiogram screening for silent atrial fibrillation (AF) in high-risk patients, even if these guidelines do not fully spell out the specific definition of high risk, according to a guideline reviewer who summarized key points at the annual International AF Symposium.

“For the first time in any guideline, we now have a recommendation for systematic ECG screening of silent AF, particularly for patients older than age 75 years or those otherwise at high risk of stroke,” reported John Camm, MD, professor of clinical cardiology, St. George’s University, London.

[email protected]

ORLANDO – New European Society of Cardiology management guidelines encourage electrocardiogram screening for silent atrial fibrillation (AF) in high-risk patients, even if these guidelines do not fully spell out the specific definition of high risk, according to a guideline reviewer who summarized key points at the annual International AF Symposium.

“For the first time in any guideline, we now have a recommendation for systematic ECG screening of silent AF, particularly for patients older than age 75 years or those otherwise at high risk of stroke,” reported John Camm, MD, professor of clinical cardiology, St. George’s University, London.

[email protected]

ORLANDO – New European Society of Cardiology management guidelines encourage electrocardiogram screening for silent atrial fibrillation (AF) in high-risk patients, even if these guidelines do not fully spell out the specific definition of high risk, according to a guideline reviewer who summarized key points at the annual International AF Symposium.

“For the first time in any guideline, we now have a recommendation for systematic ECG screening of silent AF, particularly for patients older than age 75 years or those otherwise at high risk of stroke,” reported John Camm, MD, professor of clinical cardiology, St. George’s University, London.

[email protected]

The Food and Drug Administration has granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.

Approval was based on objective response rate (ORR) in a single-arm study of 270 patients with locally advanced or metastatic urothelial carcinoma who progressed during or following platinum-containing chemotherapy, or progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Patients received nivolumab, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The ORR was 19.6% (53/270; 95% confidence interval, 15.1-24.9), according to a written statement from the FDA.

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The Food and Drug Administration has granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.

Approval was based on objective response rate (ORR) in a single-arm study of 270 patients with locally advanced or metastatic urothelial carcinoma who progressed during or following platinum-containing chemotherapy, or progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Patients received nivolumab, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The ORR was 19.6% (53/270; 95% confidence interval, 15.1-24.9), according to a written statement from the FDA.

[email protected]

The Food and Drug Administration has granted accelerated approval to nivolumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.

Approval was based on objective response rate (ORR) in a single-arm study of 270 patients with locally advanced or metastatic urothelial carcinoma who progressed during or following platinum-containing chemotherapy, or progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Patients received nivolumab, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The ORR was 19.6% (53/270; 95% confidence interval, 15.1-24.9), according to a written statement from the FDA.

[email protected]