Damian McNamara

MIAMI -- Veterans from the first Gulf War with embedded shrapnel have stronger skin reactions to metal allergy than those without shrapnel, according to the first study of cutaneous reactivity to traumatically implanted metals.
Dr. Marianna Shvartsbeyn and her colleagues patch tested 40 Gulf War I veterans to an extensive number of metal allergens and found that, overall, 25% were reactive to zinc and 12.5% to manganese.

The average number of patch test reactions for each group suggested that

Photo credit: Maura Satchell/Fotolia.com

reactions were stronger among the 18 veterans with shrapnel in their combat wounds (0.72), compared with the 22 who did not have shrapnel fragments (0.63).
Individuals with fragments also tended to react to more substances on the patch testing: The range of positive patch-test reactions was 0-4 for the group with fragments and 0-2 for the group without fragments, she noted.

A total of 56 shrapnel samples were analyzed for the study.

"The pattern of sensitivity fits with the metal components of the shrapnel extracted from the wounds of the soldiers," said Dr. Shvartsbeyn.

All participants were assessed in the spring of 2009 as part of the Depleted Uranium Follow-Up Program at the Baltimore VA Medical Center.

"Depleted uranium did not emerge as a sensitizer," said Dr. Shvartsbeyn, who was an internal medicine resident at the University of Maryland Medical Center, Baltimore, at the time of the study.

A meeting attendee asked about the source of the uranium. "It is in the bullets intended to penetrate armor and it is incorporated in some vehicle shields. Depleted uranium is a very dense metal," said session moderator Bryan Anderson of the Penn State Milton S. Hershey Medical Center, Hershey.

"Some participants had elevated urine uranium if they had retained depleted uranium shrapnel," Dr. Shvartsbeyn said, but none of these participants had significant patch- test reactions.

Embedded shrapnel can release metals over time and induce an immunologic reactivity in some people, the study suggests, said Dr. Shvartsbeyn, currently a resident in the department of pathology at New York University Medical Center, New York.

The veterans were patch tested to 42 reagents using an extended metal series (Dormer Laboratories Inc.), 50 allergens in the North American tray (Dormer), and soluble uranyl nitrate (SPI Supplies and Structure Probe Inc.). Only strong skin reactions of 1+ or above, or crescendo reactions, were considered positive.
Another meeting attendee commented that zinc often is a skin irritant. "We had a high rate of irritant reactions, but we only focused on 1+ reactions in this analysis," Dr. Shvartsbeyn replied.

Because the rates of reactivity to zinc and manganese in the general population are unknown, Dr. Shvartsbeyn and her coworkers also recruited a control group of 46 patients assessed for allergic contact dermatitis at the University of Maryland dermatology clinic from July to December 2009. This group demonstrated lower reactivity rates to zinc (8.6%) and to manganese (6.5%).
"A threefold reactivity in zinc and twofold reactivity to manganese [among the veterans] makes us think these could be the true sensitizers," she said.

MIAMI -- Veterans from the first Gulf War with embedded shrapnel have stronger skin reactions to metal allergy than those without shrapnel, according to the first study of cutaneous reactivity to traumatically implanted metals.
Dr. Marianna Shvartsbeyn and her colleagues patch tested 40 Gulf War I veterans to an extensive number of metal allergens and found that, overall, 25% were reactive to zinc and 12.5% to manganese.

The average number of patch test reactions for each group suggested that

Photo credit: Maura Satchell/Fotolia.com

reactions were stronger among the 18 veterans with shrapnel in their combat wounds (0.72), compared with the 22 who did not have shrapnel fragments (0.63).
Individuals with fragments also tended to react to more substances on the patch testing: The range of positive patch-test reactions was 0-4 for the group with fragments and 0-2 for the group without fragments, she noted.

A total of 56 shrapnel samples were analyzed for the study.

"The pattern of sensitivity fits with the metal components of the shrapnel extracted from the wounds of the soldiers," said Dr. Shvartsbeyn.

All participants were assessed in the spring of 2009 as part of the Depleted Uranium Follow-Up Program at the Baltimore VA Medical Center.

"Depleted uranium did not emerge as a sensitizer," said Dr. Shvartsbeyn, who was an internal medicine resident at the University of Maryland Medical Center, Baltimore, at the time of the study.

A meeting attendee asked about the source of the uranium. "It is in the bullets intended to penetrate armor and it is incorporated in some vehicle shields. Depleted uranium is a very dense metal," said session moderator Bryan Anderson of the Penn State Milton S. Hershey Medical Center, Hershey.

"Some participants had elevated urine uranium if they had retained depleted uranium shrapnel," Dr. Shvartsbeyn said, but none of these participants had significant patch- test reactions.

Embedded shrapnel can release metals over time and induce an immunologic reactivity in some people, the study suggests, said Dr. Shvartsbeyn, currently a resident in the department of pathology at New York University Medical Center, New York.

The veterans were patch tested to 42 reagents using an extended metal series (Dormer Laboratories Inc.), 50 allergens in the North American tray (Dormer), and soluble uranyl nitrate (SPI Supplies and Structure Probe Inc.). Only strong skin reactions of 1+ or above, or crescendo reactions, were considered positive.
Another meeting attendee commented that zinc often is a skin irritant. "We had a high rate of irritant reactions, but we only focused on 1+ reactions in this analysis," Dr. Shvartsbeyn replied.

Because the rates of reactivity to zinc and manganese in the general population are unknown, Dr. Shvartsbeyn and her coworkers also recruited a control group of 46 patients assessed for allergic contact dermatitis at the University of Maryland dermatology clinic from July to December 2009. This group demonstrated lower reactivity rates to zinc (8.6%) and to manganese (6.5%).
"A threefold reactivity in zinc and twofold reactivity to manganese [among the veterans] makes us think these could be the true sensitizers," she said.

MIAMI -- Veterans from the first Gulf War with embedded shrapnel have stronger skin reactions to metal allergy than those without shrapnel, according to the first study of cutaneous reactivity to traumatically implanted metals.
Dr. Marianna Shvartsbeyn and her colleagues patch tested 40 Gulf War I veterans to an extensive number of metal allergens and found that, overall, 25% were reactive to zinc and 12.5% to manganese.

The average number of patch test reactions for each group suggested that

Photo credit: Maura Satchell/Fotolia.com

reactions were stronger among the 18 veterans with shrapnel in their combat wounds (0.72), compared with the 22 who did not have shrapnel fragments (0.63).
Individuals with fragments also tended to react to more substances on the patch testing: The range of positive patch-test reactions was 0-4 for the group with fragments and 0-2 for the group without fragments, she noted.

A total of 56 shrapnel samples were analyzed for the study.

"The pattern of sensitivity fits with the metal components of the shrapnel extracted from the wounds of the soldiers," said Dr. Shvartsbeyn.

All participants were assessed in the spring of 2009 as part of the Depleted Uranium Follow-Up Program at the Baltimore VA Medical Center.

"Depleted uranium did not emerge as a sensitizer," said Dr. Shvartsbeyn, who was an internal medicine resident at the University of Maryland Medical Center, Baltimore, at the time of the study.

A meeting attendee asked about the source of the uranium. "It is in the bullets intended to penetrate armor and it is incorporated in some vehicle shields. Depleted uranium is a very dense metal," said session moderator Bryan Anderson of the Penn State Milton S. Hershey Medical Center, Hershey.

"Some participants had elevated urine uranium if they had retained depleted uranium shrapnel," Dr. Shvartsbeyn said, but none of these participants had significant patch- test reactions.

Embedded shrapnel can release metals over time and induce an immunologic reactivity in some people, the study suggests, said Dr. Shvartsbeyn, currently a resident in the department of pathology at New York University Medical Center, New York.

The veterans were patch tested to 42 reagents using an extended metal series (Dormer Laboratories Inc.), 50 allergens in the North American tray (Dormer), and soluble uranyl nitrate (SPI Supplies and Structure Probe Inc.). Only strong skin reactions of 1+ or above, or crescendo reactions, were considered positive.
Another meeting attendee commented that zinc often is a skin irritant. "We had a high rate of irritant reactions, but we only focused on 1+ reactions in this analysis," Dr. Shvartsbeyn replied.

Because the rates of reactivity to zinc and manganese in the general population are unknown, Dr. Shvartsbeyn and her coworkers also recruited a control group of 46 patients assessed for allergic contact dermatitis at the University of Maryland dermatology clinic from July to December 2009. This group demonstrated lower reactivity rates to zinc (8.6%) and to manganese (6.5%).
"A threefold reactivity in zinc and twofold reactivity to manganese [among the veterans] makes us think these could be the true sensitizers," she said.

ORLANDO — Psychiatrists and primary care physicians outside the military health care system have a pivotal role to play in helping to lower suicide rates, which have been on the rise across all components of the United States Army, according to according to Col. Elspeth Cameron Ritchie, MC USA.

Within the U.S. Army, suicide rates are up among all age groups and in both genders, Dr. Ritchie explained at the annual meeting of the American Association of Suicidology. Stepped-up efforts are needed to identify soldiers, reservists, and veterans who are at elevated risk.

There were about 166 suicides in the army in 2009, a rate of approximately 21 suicides per 100,000 people, or more than twice the rate in 2001.

“We have had difficulties with access to care, we have stigma, … and our services are only partially integrated,” said Dr. Ritchie, medical director of the Army Medical Department's Office of Strategic Communications.

A lack of providers who accept the military health plan, TRICARE, is a barrier to those seeking care, Dr. Ritchie said, “The best way you as a provider can help is to sign up for TRICARE.” Physicians who register for the program (www.tricare.mil

Although most active and veteran military personnel receive health care services through institutions such as Walter Reed Army Medical Center and the Veterans Affairs system, there are exceptions. For example, some soldiers are students, have private insurance, or are members of the Reserves. “One of our struggles is how to provide support when they leave active duty and go back into the Reserves.”

This is where private sector physicians come in, she said.

Risk factors for suicide among a military population can differ from the general population. The typical solider at risk of suicide does not have a long history of mental health issues. “What we don't see is major mental illness,” such as schizophrenia or bipolar disorder, that is disabling. Only about 5% of military suicides are associated with a diagnosis of personality disorders, which is “lower than I would have expected,” said Dr. Ritchie, who also is a professor of psychiatry at Uniformed Services University of the Health Sciences, in Bethesda, Md.

“We are seeing more and more” suicides spurred by relationship breakups and legal problems, she said. Under such circumstances, “unfortunately, screening does not work very well. They could screen just fine but get the 'Dear John' or 'Dear Jane' letter, buy a 12 pack, and go out and shoot themselves.”

Effective interventions in a military population will require a comprehensive look at all the elements around suicide, including posttraumatic stress disorder (PTSD), mild traumatic brain injury (TBI), and depression. “This is not going to be an issue for just 1 or 2 years, these are going to be issues for 20 years or 40 years,” Dr. Ritchie said. “So we all need to work on this together.”

The type of warfare many soldiers see when deployed in Afghanistan or Iraq increases their risk for mild TBI and associated symptoms. “The signature weapon of this war is the blast. And that causes a lot of symptoms.” Re-experiencing the trauma, numbing/avoidance, and physiologic arousal (“flight or fight” response) are the three main PTSD symptom clusters.

Army research suggests that soldiers need at least 2 years of noncombat time before their symptoms of anxiety and depression begin to wane. Re-integration can be a time of elevated risk for self-harm. “They have this high adrenaline from being in theater, and they don't know what to do with it. They take out a motorcycle and drive it at 120 mph.”

Traditionally, the military has relied on suicide-mitigation strategies such as buddy aid where one soldier might notice unusual behavior in another and recommend they go for help.

“I'm not saying these have not worked,” Dr. Ritchie said, “It's hard to know what would have happened otherwise, but it's clear [they're] not working well enough.”

The Department of Defense has mandated annual and postdeployment screening for suicide. “There is a reassessment 3-6 months after they come back because they may not be truthful right after deployment,” Dr. Ritchie said. In other words, army leadership acknowledges that some personnel might minimize their feelings immediately post combat to expedite their return home.

The DOD continues to develop and promote new prevention initiatives. A task force aimed at reducing suicide is currently working on state-of-the-art, universal, multidisciplinary suicide awareness and prevention training.

Technology to augment therapy is another strategy, one designed to overcome some access to care issues in remote areas. Virtual reality programs and telemedicine are examples. “Telemedicine is not a silver bullet,” Dr. Ritchie said. “It is very time intensive but can be effective.”

 

Are these initiatives working? “It's a little early to tell; 2009 was an extraordinary year for suicide—highest they have been,” Dr. Ritchie said. “It seems lower so far this year. We are holding our breath on that one.”

Document

70622_fx1.sml

Stepped-up efforts are needed to identify soldiers, reservists, and veterans who are at elevated risk for suicide, according to Col. Elspeth Cameron Ritchie.

Source © Maura Satchell/Fotolia.com

ORLANDO — Psychiatrists and primary care physicians outside the military health care system have a pivotal role to play in helping to lower suicide rates, which have been on the rise across all components of the United States Army, according to according to Col. Elspeth Cameron Ritchie, MC USA.

Within the U.S. Army, suicide rates are up among all age groups and in both genders, Dr. Ritchie explained at the annual meeting of the American Association of Suicidology. Stepped-up efforts are needed to identify soldiers, reservists, and veterans who are at elevated risk.

There were about 166 suicides in the army in 2009, a rate of approximately 21 suicides per 100,000 people, or more than twice the rate in 2001.

“We have had difficulties with access to care, we have stigma, … and our services are only partially integrated,” said Dr. Ritchie, medical director of the Army Medical Department's Office of Strategic Communications.

A lack of providers who accept the military health plan, TRICARE, is a barrier to those seeking care, Dr. Ritchie said, “The best way you as a provider can help is to sign up for TRICARE.” Physicians who register for the program (www.tricare.mil

Although most active and veteran military personnel receive health care services through institutions such as Walter Reed Army Medical Center and the Veterans Affairs system, there are exceptions. For example, some soldiers are students, have private insurance, or are members of the Reserves. “One of our struggles is how to provide support when they leave active duty and go back into the Reserves.”

This is where private sector physicians come in, she said.

Risk factors for suicide among a military population can differ from the general population. The typical solider at risk of suicide does not have a long history of mental health issues. “What we don't see is major mental illness,” such as schizophrenia or bipolar disorder, that is disabling. Only about 5% of military suicides are associated with a diagnosis of personality disorders, which is “lower than I would have expected,” said Dr. Ritchie, who also is a professor of psychiatry at Uniformed Services University of the Health Sciences, in Bethesda, Md.

“We are seeing more and more” suicides spurred by relationship breakups and legal problems, she said. Under such circumstances, “unfortunately, screening does not work very well. They could screen just fine but get the 'Dear John' or 'Dear Jane' letter, buy a 12 pack, and go out and shoot themselves.”

Effective interventions in a military population will require a comprehensive look at all the elements around suicide, including posttraumatic stress disorder (PTSD), mild traumatic brain injury (TBI), and depression. “This is not going to be an issue for just 1 or 2 years, these are going to be issues for 20 years or 40 years,” Dr. Ritchie said. “So we all need to work on this together.”

The type of warfare many soldiers see when deployed in Afghanistan or Iraq increases their risk for mild TBI and associated symptoms. “The signature weapon of this war is the blast. And that causes a lot of symptoms.” Re-experiencing the trauma, numbing/avoidance, and physiologic arousal (“flight or fight” response) are the three main PTSD symptom clusters.

Army research suggests that soldiers need at least 2 years of noncombat time before their symptoms of anxiety and depression begin to wane. Re-integration can be a time of elevated risk for self-harm. “They have this high adrenaline from being in theater, and they don't know what to do with it. They take out a motorcycle and drive it at 120 mph.”

Traditionally, the military has relied on suicide-mitigation strategies such as buddy aid where one soldier might notice unusual behavior in another and recommend they go for help.

“I'm not saying these have not worked,” Dr. Ritchie said, “It's hard to know what would have happened otherwise, but it's clear [they're] not working well enough.”

The Department of Defense has mandated annual and postdeployment screening for suicide. “There is a reassessment 3-6 months after they come back because they may not be truthful right after deployment,” Dr. Ritchie said. In other words, army leadership acknowledges that some personnel might minimize their feelings immediately post combat to expedite their return home.

The DOD continues to develop and promote new prevention initiatives. A task force aimed at reducing suicide is currently working on state-of-the-art, universal, multidisciplinary suicide awareness and prevention training.

Technology to augment therapy is another strategy, one designed to overcome some access to care issues in remote areas. Virtual reality programs and telemedicine are examples. “Telemedicine is not a silver bullet,” Dr. Ritchie said. “It is very time intensive but can be effective.”

 

Are these initiatives working? “It's a little early to tell; 2009 was an extraordinary year for suicide—highest they have been,” Dr. Ritchie said. “It seems lower so far this year. We are holding our breath on that one.”

Document

70622_fx1.sml

Stepped-up efforts are needed to identify soldiers, reservists, and veterans who are at elevated risk for suicide, according to Col. Elspeth Cameron Ritchie.

Source © Maura Satchell/Fotolia.com

ORLANDO — Psychiatrists and primary care physicians outside the military health care system have a pivotal role to play in helping to lower suicide rates, which have been on the rise across all components of the United States Army, according to according to Col. Elspeth Cameron Ritchie, MC USA.

Within the U.S. Army, suicide rates are up among all age groups and in both genders, Dr. Ritchie explained at the annual meeting of the American Association of Suicidology. Stepped-up efforts are needed to identify soldiers, reservists, and veterans who are at elevated risk.

There were about 166 suicides in the army in 2009, a rate of approximately 21 suicides per 100,000 people, or more than twice the rate in 2001.

“We have had difficulties with access to care, we have stigma, … and our services are only partially integrated,” said Dr. Ritchie, medical director of the Army Medical Department's Office of Strategic Communications.

A lack of providers who accept the military health plan, TRICARE, is a barrier to those seeking care, Dr. Ritchie said, “The best way you as a provider can help is to sign up for TRICARE.” Physicians who register for the program (www.tricare.mil

Although most active and veteran military personnel receive health care services through institutions such as Walter Reed Army Medical Center and the Veterans Affairs system, there are exceptions. For example, some soldiers are students, have private insurance, or are members of the Reserves. “One of our struggles is how to provide support when they leave active duty and go back into the Reserves.”

This is where private sector physicians come in, she said.

Risk factors for suicide among a military population can differ from the general population. The typical solider at risk of suicide does not have a long history of mental health issues. “What we don't see is major mental illness,” such as schizophrenia or bipolar disorder, that is disabling. Only about 5% of military suicides are associated with a diagnosis of personality disorders, which is “lower than I would have expected,” said Dr. Ritchie, who also is a professor of psychiatry at Uniformed Services University of the Health Sciences, in Bethesda, Md.

“We are seeing more and more” suicides spurred by relationship breakups and legal problems, she said. Under such circumstances, “unfortunately, screening does not work very well. They could screen just fine but get the 'Dear John' or 'Dear Jane' letter, buy a 12 pack, and go out and shoot themselves.”

Effective interventions in a military population will require a comprehensive look at all the elements around suicide, including posttraumatic stress disorder (PTSD), mild traumatic brain injury (TBI), and depression. “This is not going to be an issue for just 1 or 2 years, these are going to be issues for 20 years or 40 years,” Dr. Ritchie said. “So we all need to work on this together.”

The type of warfare many soldiers see when deployed in Afghanistan or Iraq increases their risk for mild TBI and associated symptoms. “The signature weapon of this war is the blast. And that causes a lot of symptoms.” Re-experiencing the trauma, numbing/avoidance, and physiologic arousal (“flight or fight” response) are the three main PTSD symptom clusters.

Army research suggests that soldiers need at least 2 years of noncombat time before their symptoms of anxiety and depression begin to wane. Re-integration can be a time of elevated risk for self-harm. “They have this high adrenaline from being in theater, and they don't know what to do with it. They take out a motorcycle and drive it at 120 mph.”

Traditionally, the military has relied on suicide-mitigation strategies such as buddy aid where one soldier might notice unusual behavior in another and recommend they go for help.

“I'm not saying these have not worked,” Dr. Ritchie said, “It's hard to know what would have happened otherwise, but it's clear [they're] not working well enough.”

The Department of Defense has mandated annual and postdeployment screening for suicide. “There is a reassessment 3-6 months after they come back because they may not be truthful right after deployment,” Dr. Ritchie said. In other words, army leadership acknowledges that some personnel might minimize their feelings immediately post combat to expedite their return home.

The DOD continues to develop and promote new prevention initiatives. A task force aimed at reducing suicide is currently working on state-of-the-art, universal, multidisciplinary suicide awareness and prevention training.

Technology to augment therapy is another strategy, one designed to overcome some access to care issues in remote areas. Virtual reality programs and telemedicine are examples. “Telemedicine is not a silver bullet,” Dr. Ritchie said. “It is very time intensive but can be effective.”

 

Are these initiatives working? “It's a little early to tell; 2009 was an extraordinary year for suicide—highest they have been,” Dr. Ritchie said. “It seems lower so far this year. We are holding our breath on that one.”

Document

70622_fx1.sml

Stepped-up efforts are needed to identify soldiers, reservists, and veterans who are at elevated risk for suicide, according to Col. Elspeth Cameron Ritchie.

Source © Maura Satchell/Fotolia.com

MIAMI — Varying degrees of success and some caveats come with the use of probiotics to combat or prevent Clostridium difficile infection and antibiotic-associated diarrhea.

Saccharomyces boulardii, lactobacilli, and bifidobacteria are among the better-studied probiotic options for these purposes, Dr. Curtis Danskey said at the International Probiotics Association World Congress.

Many hospitalized patients do not have normal gut flora, but “if we can restore the normal intestinal flora, an effective probiotic may protect [these] patients,” said Dr. Danskey, who is on the medicine faculty at Louis Stokes Cleveland VA Medical Center.

The antibiotics routinely prescribed to fight C. difficile also kill beneficial flora in the gut, which is where probiotic therapy might help. “There is evidence [supporting the] use of probiotics for antibiotic-associated diarrhea if you want to use them,” Dr. Danskey said.

▸ Saccharomyces boulardii. This organism is a type of yeast and is “probably one of the most well-studied probiotics for C. difficile,” Dr. Danskey said. In one study, patients with C. difficile disease experienced a significant reduction in recurrences when treated with high-dose vancomycin for 10 days followed by S. boulardii for 28 days, compared with a regimen of vancomycin followed by placebo (Clin. Infect. Dis. 2000;31:1012-7).

On the downside, there have been reports of fungemia associated with S. boulardii treatment, particularly in immunocompromised patients, Dr. Danskey said (Crit. Care 2008;12:414). There is a risk of transfer of fungemia to patients, so “I will not use it in my ICU, [but I] may use it in an outpatient setting in someone with recurrent infections.”

▸ Lactobacilli and bifidobacteria. There is some rationale for use of these two probiotic species to prevent C. difficile infection, Dr. Danskey said. Lactobacilli, for example, can inhibit growth of C. difficile in vitro (J. Med. Microbiol. 2004;53:551-4). Also, reduced lactobacilli levels were found in the stool of hospitalized patients with C. difficile (Clin. Infect. Dis. 1997;25[suppl 2]:S189-90). “A lack of these organisms may allow C. difficile to grow.”

Historically, the numbers have been small in many probiotic trials that did not show a reduction in C. difficile infection. “Up to 2005, the data were not very convincing,” Dr. Danskey said.

After that, reports became more robust. For example, in one study, 135 hospitalized patients aged 50 years and older taking antibiotics were randomized to a lactobacillus preparation or placebo (BMJ 2007;335:80). A total of 12% of the probiotic group developed AAD, compared with 34% of placebo patients. In addition, no patient who took the probiotic developed a C. difficile infection vs. 17% of the placebo group.

“The results looked very impressive,” Dr. Danskey said. However, the study received a fair amount of criticism. For example, the placebo group drank a sterile milkshake, which could have caused diarrhea, some said. Other aspects of the study that drew criticism included the highly selected patient population (only 8% of screened patients were enrolled) and the exclusion of patients taking antibiotics most likely to cause diarrhea.

“However, the 8% rate is still higher than a just-published study [of monoclonal antibodies targeted against C. difficile toxins] that only enrolled 3% of screened patients,” Dr. Danskey said (N. Engl. J. Med. 2010;362:197-205). Also, in the 2007 lactobacillus vs. placebo study, 43 of 69 probiotic-treated patients (62%) received a high-risk antibiotic, as did 46 of the 66 placebo patients (70%), he said.

In terms of potential adverse events, there are some concerns about safety, “although we eat yogurt [with lactobacillus species] all the time,” Dr. Danskey said. For example, researchers reported two cases of sepsis associated with probiotic lactobacillus strains (Pediatrics 2005; 115:178-810).

A meta-analysis of probiotics for AAD and C. difficile infection was published a year ago (Anaerobe 2009;15:274-80).

▸ Nontoxigenic probiotics. Normally, C. difficile growth and toxin production start shortly after infection in susceptible individuals. A person can be an asymptomatic carrier, but about one-third of patients develop disease, Dr. Danskey said. When this happens, C. difficile toxins bind to the lining of the GI tract, leading to cell death and significant inflammation. Colonoscopy and sigmoidoscopy often show pseudomembranous colitis in these patients.

Nontoxigenic probiotics that compete with C. difficile are in development. “Evidence suggests patients colonized with nontoxigenic strains were protected from infection with toxigenic strains,” Dr. Danskey said.

Dr. Danskey receives research support from Viral Pharma (which is developing nontoxigenic probiotic strains) and the Department of Veterans Affairs.

Document

70618_fx1.sml

The antibiotics for C. difficile also kill beneficial flora, which is where probiotic therapy might help.

Source DR. DANSKEY

MIAMI — Varying degrees of success and some caveats come with the use of probiotics to combat or prevent Clostridium difficile infection and antibiotic-associated diarrhea.

Saccharomyces boulardii, lactobacilli, and bifidobacteria are among the better-studied probiotic options for these purposes, Dr. Curtis Danskey said at the International Probiotics Association World Congress.

Many hospitalized patients do not have normal gut flora, but “if we can restore the normal intestinal flora, an effective probiotic may protect [these] patients,” said Dr. Danskey, who is on the medicine faculty at Louis Stokes Cleveland VA Medical Center.

The antibiotics routinely prescribed to fight C. difficile also kill beneficial flora in the gut, which is where probiotic therapy might help. “There is evidence [supporting the] use of probiotics for antibiotic-associated diarrhea if you want to use them,” Dr. Danskey said.

▸ Saccharomyces boulardii. This organism is a type of yeast and is “probably one of the most well-studied probiotics for C. difficile,” Dr. Danskey said. In one study, patients with C. difficile disease experienced a significant reduction in recurrences when treated with high-dose vancomycin for 10 days followed by S. boulardii for 28 days, compared with a regimen of vancomycin followed by placebo (Clin. Infect. Dis. 2000;31:1012-7).

On the downside, there have been reports of fungemia associated with S. boulardii treatment, particularly in immunocompromised patients, Dr. Danskey said (Crit. Care 2008;12:414). There is a risk of transfer of fungemia to patients, so “I will not use it in my ICU, [but I] may use it in an outpatient setting in someone with recurrent infections.”

▸ Lactobacilli and bifidobacteria. There is some rationale for use of these two probiotic species to prevent C. difficile infection, Dr. Danskey said. Lactobacilli, for example, can inhibit growth of C. difficile in vitro (J. Med. Microbiol. 2004;53:551-4). Also, reduced lactobacilli levels were found in the stool of hospitalized patients with C. difficile (Clin. Infect. Dis. 1997;25[suppl 2]:S189-90). “A lack of these organisms may allow C. difficile to grow.”

Historically, the numbers have been small in many probiotic trials that did not show a reduction in C. difficile infection. “Up to 2005, the data were not very convincing,” Dr. Danskey said.

After that, reports became more robust. For example, in one study, 135 hospitalized patients aged 50 years and older taking antibiotics were randomized to a lactobacillus preparation or placebo (BMJ 2007;335:80). A total of 12% of the probiotic group developed AAD, compared with 34% of placebo patients. In addition, no patient who took the probiotic developed a C. difficile infection vs. 17% of the placebo group.

“The results looked very impressive,” Dr. Danskey said. However, the study received a fair amount of criticism. For example, the placebo group drank a sterile milkshake, which could have caused diarrhea, some said. Other aspects of the study that drew criticism included the highly selected patient population (only 8% of screened patients were enrolled) and the exclusion of patients taking antibiotics most likely to cause diarrhea.

“However, the 8% rate is still higher than a just-published study [of monoclonal antibodies targeted against C. difficile toxins] that only enrolled 3% of screened patients,” Dr. Danskey said (N. Engl. J. Med. 2010;362:197-205). Also, in the 2007 lactobacillus vs. placebo study, 43 of 69 probiotic-treated patients (62%) received a high-risk antibiotic, as did 46 of the 66 placebo patients (70%), he said.

In terms of potential adverse events, there are some concerns about safety, “although we eat yogurt [with lactobacillus species] all the time,” Dr. Danskey said. For example, researchers reported two cases of sepsis associated with probiotic lactobacillus strains (Pediatrics 2005; 115:178-810).

A meta-analysis of probiotics for AAD and C. difficile infection was published a year ago (Anaerobe 2009;15:274-80).

▸ Nontoxigenic probiotics. Normally, C. difficile growth and toxin production start shortly after infection in susceptible individuals. A person can be an asymptomatic carrier, but about one-third of patients develop disease, Dr. Danskey said. When this happens, C. difficile toxins bind to the lining of the GI tract, leading to cell death and significant inflammation. Colonoscopy and sigmoidoscopy often show pseudomembranous colitis in these patients.

Nontoxigenic probiotics that compete with C. difficile are in development. “Evidence suggests patients colonized with nontoxigenic strains were protected from infection with toxigenic strains,” Dr. Danskey said.

Dr. Danskey receives research support from Viral Pharma (which is developing nontoxigenic probiotic strains) and the Department of Veterans Affairs.

Document

70618_fx1.sml

The antibiotics for C. difficile also kill beneficial flora, which is where probiotic therapy might help.

Source DR. DANSKEY

MIAMI — Varying degrees of success and some caveats come with the use of probiotics to combat or prevent Clostridium difficile infection and antibiotic-associated diarrhea.

Saccharomyces boulardii, lactobacilli, and bifidobacteria are among the better-studied probiotic options for these purposes, Dr. Curtis Danskey said at the International Probiotics Association World Congress.

Many hospitalized patients do not have normal gut flora, but “if we can restore the normal intestinal flora, an effective probiotic may protect [these] patients,” said Dr. Danskey, who is on the medicine faculty at Louis Stokes Cleveland VA Medical Center.

The antibiotics routinely prescribed to fight C. difficile also kill beneficial flora in the gut, which is where probiotic therapy might help. “There is evidence [supporting the] use of probiotics for antibiotic-associated diarrhea if you want to use them,” Dr. Danskey said.

▸ Saccharomyces boulardii. This organism is a type of yeast and is “probably one of the most well-studied probiotics for C. difficile,” Dr. Danskey said. In one study, patients with C. difficile disease experienced a significant reduction in recurrences when treated with high-dose vancomycin for 10 days followed by S. boulardii for 28 days, compared with a regimen of vancomycin followed by placebo (Clin. Infect. Dis. 2000;31:1012-7).

On the downside, there have been reports of fungemia associated with S. boulardii treatment, particularly in immunocompromised patients, Dr. Danskey said (Crit. Care 2008;12:414). There is a risk of transfer of fungemia to patients, so “I will not use it in my ICU, [but I] may use it in an outpatient setting in someone with recurrent infections.”

▸ Lactobacilli and bifidobacteria. There is some rationale for use of these two probiotic species to prevent C. difficile infection, Dr. Danskey said. Lactobacilli, for example, can inhibit growth of C. difficile in vitro (J. Med. Microbiol. 2004;53:551-4). Also, reduced lactobacilli levels were found in the stool of hospitalized patients with C. difficile (Clin. Infect. Dis. 1997;25[suppl 2]:S189-90). “A lack of these organisms may allow C. difficile to grow.”

Historically, the numbers have been small in many probiotic trials that did not show a reduction in C. difficile infection. “Up to 2005, the data were not very convincing,” Dr. Danskey said.

After that, reports became more robust. For example, in one study, 135 hospitalized patients aged 50 years and older taking antibiotics were randomized to a lactobacillus preparation or placebo (BMJ 2007;335:80). A total of 12% of the probiotic group developed AAD, compared with 34% of placebo patients. In addition, no patient who took the probiotic developed a C. difficile infection vs. 17% of the placebo group.

“The results looked very impressive,” Dr. Danskey said. However, the study received a fair amount of criticism. For example, the placebo group drank a sterile milkshake, which could have caused diarrhea, some said. Other aspects of the study that drew criticism included the highly selected patient population (only 8% of screened patients were enrolled) and the exclusion of patients taking antibiotics most likely to cause diarrhea.

“However, the 8% rate is still higher than a just-published study [of monoclonal antibodies targeted against C. difficile toxins] that only enrolled 3% of screened patients,” Dr. Danskey said (N. Engl. J. Med. 2010;362:197-205). Also, in the 2007 lactobacillus vs. placebo study, 43 of 69 probiotic-treated patients (62%) received a high-risk antibiotic, as did 46 of the 66 placebo patients (70%), he said.

In terms of potential adverse events, there are some concerns about safety, “although we eat yogurt [with lactobacillus species] all the time,” Dr. Danskey said. For example, researchers reported two cases of sepsis associated with probiotic lactobacillus strains (Pediatrics 2005; 115:178-810).

A meta-analysis of probiotics for AAD and C. difficile infection was published a year ago (Anaerobe 2009;15:274-80).

▸ Nontoxigenic probiotics. Normally, C. difficile growth and toxin production start shortly after infection in susceptible individuals. A person can be an asymptomatic carrier, but about one-third of patients develop disease, Dr. Danskey said. When this happens, C. difficile toxins bind to the lining of the GI tract, leading to cell death and significant inflammation. Colonoscopy and sigmoidoscopy often show pseudomembranous colitis in these patients.

Nontoxigenic probiotics that compete with C. difficile are in development. “Evidence suggests patients colonized with nontoxigenic strains were protected from infection with toxigenic strains,” Dr. Danskey said.

Dr. Danskey receives research support from Viral Pharma (which is developing nontoxigenic probiotic strains) and the Department of Veterans Affairs.

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The antibiotics for C. difficile also kill beneficial flora, which is where probiotic therapy might help.

Source DR. DANSKEY

Major Finding: Computerized, automated device detects melanoma and high-grade dysplastic nevi with 98% sensitivity.

Data Source: A prospective, multicenter study of 1,632 lesions.

Disclosures: Dr. Monheit is a consultant and researcher for Electro-Optical Sciences.

MIAMI — A computer-automated device detected melanoma and high-grade dysplastic nevi lesions with 98% sensitivity in a large, prospective, multicenter study.

The digital dermoscopy device “sees” at different skin depths using 10 spectral bands ranging from 430 nm to 950 nm. The device objectively assesses up to 75 factors to differentiate melanoma from low-grade and high-grade dysplastic nevi, Dr. Gary D. Monheit said.

The technology was more than a decade in development, which involved assessment of more than 10,000 pigmented lesions from more than 7,000 patients, Dr. Monheit said at the annual meeting of the American Academy of Dermatology.

Dr. Monheit was an investigator at one of seven sites that used the MelaFind (Electro-Optical Sciences) to assess a total of 1,632 evaluable lesions. Lesions included 70 invasive melanomas and 57 melanoma in situ. “This is the largest prospective, blinded study ever conducted in melanoma detection,” he noted.

The noninvasive device has a handheld wand for image capture at the point of care. Because of these features and a proprietary algorithm that analyzes multiple spectrums, it is “totally objective with a yes or no algorithm for excision,” said Dr. Monheit, a private practice dermatologist in Birmingham, Ala., and an associate clinical professor in the departments of dermatology and ophthalmology at the University of Alabama at Birmingham.

Detection is automatic with immediate feedback, Dr. Monheit said. “If we don't get a clear image, the machine tells us the image is not possible.”

The aim of this “pivotal study” was to establish safety of the device and sensitivity for melanoma detection. No adverse events were reported, Dr. Monheit said. Lesions had to be pigmented with melanin, keratin, and/or blood. Clinical management was biopsy, he added.

For melanoma and high-grade dysplastic nevi, the device had a 98% sensitivity. These are the lesions that should be removed, Dr. Monheit said.

“At same time we should look at specificity—we do not want to biopsy every lesion,” Dr. Monheit said. The specificity of the device was 9.4%, statistically superior to the dermatologist evaluations at 3.7%.

The results with the device were compared with prebiopsy investigator diagnoses and with an objective pathologic review of lesions by a panel of three dermatopathologists. If two of the three dermatopathologists concurred on the diagnosis, their consensus was final. The device had a 98% sensitivity for biopsy detection.

Dr. Monheit and the other study investigators also collected patient data, including age, gender, ethnicity, patient in-house or referred, and any risk factors for melanoma. Anatomic locations of the lesions were also noted.

This study provides “evidence for safety and efficacy for aid in evaluating pigmented lesions,” Dr. Monheit said.

Major Finding: Computerized, automated device detects melanoma and high-grade dysplastic nevi with 98% sensitivity.

Data Source: A prospective, multicenter study of 1,632 lesions.

Disclosures: Dr. Monheit is a consultant and researcher for Electro-Optical Sciences.

MIAMI — A computer-automated device detected melanoma and high-grade dysplastic nevi lesions with 98% sensitivity in a large, prospective, multicenter study.

The digital dermoscopy device “sees” at different skin depths using 10 spectral bands ranging from 430 nm to 950 nm. The device objectively assesses up to 75 factors to differentiate melanoma from low-grade and high-grade dysplastic nevi, Dr. Gary D. Monheit said.

The technology was more than a decade in development, which involved assessment of more than 10,000 pigmented lesions from more than 7,000 patients, Dr. Monheit said at the annual meeting of the American Academy of Dermatology.

Dr. Monheit was an investigator at one of seven sites that used the MelaFind (Electro-Optical Sciences) to assess a total of 1,632 evaluable lesions. Lesions included 70 invasive melanomas and 57 melanoma in situ. “This is the largest prospective, blinded study ever conducted in melanoma detection,” he noted.

The noninvasive device has a handheld wand for image capture at the point of care. Because of these features and a proprietary algorithm that analyzes multiple spectrums, it is “totally objective with a yes or no algorithm for excision,” said Dr. Monheit, a private practice dermatologist in Birmingham, Ala., and an associate clinical professor in the departments of dermatology and ophthalmology at the University of Alabama at Birmingham.

Detection is automatic with immediate feedback, Dr. Monheit said. “If we don't get a clear image, the machine tells us the image is not possible.”

The aim of this “pivotal study” was to establish safety of the device and sensitivity for melanoma detection. No adverse events were reported, Dr. Monheit said. Lesions had to be pigmented with melanin, keratin, and/or blood. Clinical management was biopsy, he added.

For melanoma and high-grade dysplastic nevi, the device had a 98% sensitivity. These are the lesions that should be removed, Dr. Monheit said.

“At same time we should look at specificity—we do not want to biopsy every lesion,” Dr. Monheit said. The specificity of the device was 9.4%, statistically superior to the dermatologist evaluations at 3.7%.

The results with the device were compared with prebiopsy investigator diagnoses and with an objective pathologic review of lesions by a panel of three dermatopathologists. If two of the three dermatopathologists concurred on the diagnosis, their consensus was final. The device had a 98% sensitivity for biopsy detection.

Dr. Monheit and the other study investigators also collected patient data, including age, gender, ethnicity, patient in-house or referred, and any risk factors for melanoma. Anatomic locations of the lesions were also noted.

This study provides “evidence for safety and efficacy for aid in evaluating pigmented lesions,” Dr. Monheit said.

Major Finding: Computerized, automated device detects melanoma and high-grade dysplastic nevi with 98% sensitivity.

Data Source: A prospective, multicenter study of 1,632 lesions.

Disclosures: Dr. Monheit is a consultant and researcher for Electro-Optical Sciences.

MIAMI — A computer-automated device detected melanoma and high-grade dysplastic nevi lesions with 98% sensitivity in a large, prospective, multicenter study.

The digital dermoscopy device “sees” at different skin depths using 10 spectral bands ranging from 430 nm to 950 nm. The device objectively assesses up to 75 factors to differentiate melanoma from low-grade and high-grade dysplastic nevi, Dr. Gary D. Monheit said.

The technology was more than a decade in development, which involved assessment of more than 10,000 pigmented lesions from more than 7,000 patients, Dr. Monheit said at the annual meeting of the American Academy of Dermatology.

Dr. Monheit was an investigator at one of seven sites that used the MelaFind (Electro-Optical Sciences) to assess a total of 1,632 evaluable lesions. Lesions included 70 invasive melanomas and 57 melanoma in situ. “This is the largest prospective, blinded study ever conducted in melanoma detection,” he noted.

The noninvasive device has a handheld wand for image capture at the point of care. Because of these features and a proprietary algorithm that analyzes multiple spectrums, it is “totally objective with a yes or no algorithm for excision,” said Dr. Monheit, a private practice dermatologist in Birmingham, Ala., and an associate clinical professor in the departments of dermatology and ophthalmology at the University of Alabama at Birmingham.

Detection is automatic with immediate feedback, Dr. Monheit said. “If we don't get a clear image, the machine tells us the image is not possible.”

The aim of this “pivotal study” was to establish safety of the device and sensitivity for melanoma detection. No adverse events were reported, Dr. Monheit said. Lesions had to be pigmented with melanin, keratin, and/or blood. Clinical management was biopsy, he added.

For melanoma and high-grade dysplastic nevi, the device had a 98% sensitivity. These are the lesions that should be removed, Dr. Monheit said.

“At same time we should look at specificity—we do not want to biopsy every lesion,” Dr. Monheit said. The specificity of the device was 9.4%, statistically superior to the dermatologist evaluations at 3.7%.

The results with the device were compared with prebiopsy investigator diagnoses and with an objective pathologic review of lesions by a panel of three dermatopathologists. If two of the three dermatopathologists concurred on the diagnosis, their consensus was final. The device had a 98% sensitivity for biopsy detection.

Dr. Monheit and the other study investigators also collected patient data, including age, gender, ethnicity, patient in-house or referred, and any risk factors for melanoma. Anatomic locations of the lesions were also noted.

This study provides “evidence for safety and efficacy for aid in evaluating pigmented lesions,” Dr. Monheit said.

Visible and infrared high-power lasers can cause permanent skin and organ damage if used inappropriately.

Patient protection measures, government and institutional guidelines, and familiarity with the physics behind laser technology are means by which dermatologists can optimize safety, Dr. E. Victor Ross said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation in Santa Monica, Calif.

Mild to severe reddening, blisters, charring, depigmentation, ulceration, and scarring are among possible adverse effects when these devices are not employed safely, he said.

Even when just the skin is being treated, protective measures are warranted for the eyes, said Dr. Ross, director of the Scripps Clinic Laser and Cosmetic Dermatology Center in Carmel Valley, Calif.

Visible light and some infrared-wavelength light is focused as it enters the eye, making the eyes even more susceptible to laser damage. There have been reports of severe and sometimes permanent eye injuries with lasers. One patient, for example, reported seeing a white flash and hearing a click during treatment with an Nd:YAG 1064-nm laser. The result was a dark spot in the patient's visual field resulted, he said.

Protective eyewear is of paramount importance, Dr. Ross said. Select eyewear based on the laser and the anatomic region being treated. Look for eyewear marked with the wavelengths it protects against and the degree of light energy attenuation. Caution is advised when using goggles on pediatric patients because the fit may not be ideal.

In a very practical sense, Dr. Ross also advised that staff keep cups of water or coffee off the lasers. A spill or leak can get into the device power supply and cause an "explosion." In addition, never open the part of the laser where the high voltage energy is located, said Dr. Ross.

He recommended following the American National Standards Institute's (ANSI) series of laser safety standards. The recommendations are recognized by many hospitals as the standard for guiding a laser safety program, he said.

Examples of ANSI standards include physicians acting as the safety officer, routine laser maintenance, and having a set of standard operating procedures that is kept on file. Recommendations are not just for large practices, Dr. Ross said. "Even a small clinic should have a laser safety officer."

Government safety standards for laser use are available from the Occupational Safety and Health Administration and the Food and Drug Administration's Center for Devices and Radiological Health. Having a sign posted near each device warning of potential hazards specific to that class of laser is an example of a government safety standard, he said.

There are four general safety categories for lasers:

Class 1. Low-power device that is considered safe.

Class 2. The eye blink response generally provides enough eye protection during use.

Class 3. Direct exposure of the eye to these medium-power devices has potential to cause harm.

Class 4. These high-power devices require the most caution to avoid eye and skin hazards through direct and reflected exposure. These lasers also can pose a fire hazard if nearby materials are accidentally ignited from direct or scattered beams.

Credentialing is another safety measure. All clinicians operating a laser at the Scripps Clinic, for example, must be credentialed for that specific device and wavelength. Requirements include some didactic training, supervision during three or more laser treatments, and hands-on instruction by the device manufacturer, Dr. Ross said.

As with most government standards, there is official terminology regarding laser safety. Maximal permissible exposure (MPE) is an official term, describing the amount of irradiance to which a patient can be exposed without causing eye or skin damage. It is important to note that patient discomfort is possible within the MPE limitations. The MPE is calculated using wavelength and duration of laser exposure.

Dermatologists can optimize safety with knowledge of the basic physics behind the energy delivered in laser light and how it provides benefits to the skin when delivered properly, he suggested.

Power delivered per unit area is called the irradiance. This is typically expressed as the power in watts per square centimeter. Many dermatologists and device manufacturers compare lasers and outcomes in terms of joules, which is the energy delivered per square centimeter.

On the patient end, science determines the depth to which laser light penetrates and is absorbed. This absorption coefficient varies among hemoglobin, melanin, and water, for example. Each component interacts to a different extent with laser energy, and dermatologists utilize this selective photothermolysis to optimize patient outcomes from laser treatments, he said.

Dr. Ross disclosed that he is a researcher for and receives funding from multiple laser companies, including Candela, Cutera, Lumenis, Sciton, and Syneron.

 

SDEF and this news organization are owned by Elsevier.

Visible and infrared high-power lasers can cause permanent skin and organ damage if used inappropriately.

Patient protection measures, government and institutional guidelines, and familiarity with the physics behind laser technology are means by which dermatologists can optimize safety, Dr. E. Victor Ross said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation in Santa Monica, Calif.

Mild to severe reddening, blisters, charring, depigmentation, ulceration, and scarring are among possible adverse effects when these devices are not employed safely, he said.

Even when just the skin is being treated, protective measures are warranted for the eyes, said Dr. Ross, director of the Scripps Clinic Laser and Cosmetic Dermatology Center in Carmel Valley, Calif.

Visible light and some infrared-wavelength light is focused as it enters the eye, making the eyes even more susceptible to laser damage. There have been reports of severe and sometimes permanent eye injuries with lasers. One patient, for example, reported seeing a white flash and hearing a click during treatment with an Nd:YAG 1064-nm laser. The result was a dark spot in the patient's visual field resulted, he said.

Protective eyewear is of paramount importance, Dr. Ross said. Select eyewear based on the laser and the anatomic region being treated. Look for eyewear marked with the wavelengths it protects against and the degree of light energy attenuation. Caution is advised when using goggles on pediatric patients because the fit may not be ideal.

In a very practical sense, Dr. Ross also advised that staff keep cups of water or coffee off the lasers. A spill or leak can get into the device power supply and cause an "explosion." In addition, never open the part of the laser where the high voltage energy is located, said Dr. Ross.

He recommended following the American National Standards Institute's (ANSI) series of laser safety standards. The recommendations are recognized by many hospitals as the standard for guiding a laser safety program, he said.

Examples of ANSI standards include physicians acting as the safety officer, routine laser maintenance, and having a set of standard operating procedures that is kept on file. Recommendations are not just for large practices, Dr. Ross said. "Even a small clinic should have a laser safety officer."

Government safety standards for laser use are available from the Occupational Safety and Health Administration and the Food and Drug Administration's Center for Devices and Radiological Health. Having a sign posted near each device warning of potential hazards specific to that class of laser is an example of a government safety standard, he said.

There are four general safety categories for lasers:

Class 1. Low-power device that is considered safe.

Class 2. The eye blink response generally provides enough eye protection during use.

Class 3. Direct exposure of the eye to these medium-power devices has potential to cause harm.

Class 4. These high-power devices require the most caution to avoid eye and skin hazards through direct and reflected exposure. These lasers also can pose a fire hazard if nearby materials are accidentally ignited from direct or scattered beams.

Credentialing is another safety measure. All clinicians operating a laser at the Scripps Clinic, for example, must be credentialed for that specific device and wavelength. Requirements include some didactic training, supervision during three or more laser treatments, and hands-on instruction by the device manufacturer, Dr. Ross said.

As with most government standards, there is official terminology regarding laser safety. Maximal permissible exposure (MPE) is an official term, describing the amount of irradiance to which a patient can be exposed without causing eye or skin damage. It is important to note that patient discomfort is possible within the MPE limitations. The MPE is calculated using wavelength and duration of laser exposure.

Dermatologists can optimize safety with knowledge of the basic physics behind the energy delivered in laser light and how it provides benefits to the skin when delivered properly, he suggested.

Power delivered per unit area is called the irradiance. This is typically expressed as the power in watts per square centimeter. Many dermatologists and device manufacturers compare lasers and outcomes in terms of joules, which is the energy delivered per square centimeter.

On the patient end, science determines the depth to which laser light penetrates and is absorbed. This absorption coefficient varies among hemoglobin, melanin, and water, for example. Each component interacts to a different extent with laser energy, and dermatologists utilize this selective photothermolysis to optimize patient outcomes from laser treatments, he said.

Dr. Ross disclosed that he is a researcher for and receives funding from multiple laser companies, including Candela, Cutera, Lumenis, Sciton, and Syneron.

 

SDEF and this news organization are owned by Elsevier.

Visible and infrared high-power lasers can cause permanent skin and organ damage if used inappropriately.

Patient protection measures, government and institutional guidelines, and familiarity with the physics behind laser technology are means by which dermatologists can optimize safety, Dr. E. Victor Ross said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation in Santa Monica, Calif.

Mild to severe reddening, blisters, charring, depigmentation, ulceration, and scarring are among possible adverse effects when these devices are not employed safely, he said.

Even when just the skin is being treated, protective measures are warranted for the eyes, said Dr. Ross, director of the Scripps Clinic Laser and Cosmetic Dermatology Center in Carmel Valley, Calif.

Visible light and some infrared-wavelength light is focused as it enters the eye, making the eyes even more susceptible to laser damage. There have been reports of severe and sometimes permanent eye injuries with lasers. One patient, for example, reported seeing a white flash and hearing a click during treatment with an Nd:YAG 1064-nm laser. The result was a dark spot in the patient's visual field resulted, he said.

Protective eyewear is of paramount importance, Dr. Ross said. Select eyewear based on the laser and the anatomic region being treated. Look for eyewear marked with the wavelengths it protects against and the degree of light energy attenuation. Caution is advised when using goggles on pediatric patients because the fit may not be ideal.

In a very practical sense, Dr. Ross also advised that staff keep cups of water or coffee off the lasers. A spill or leak can get into the device power supply and cause an "explosion." In addition, never open the part of the laser where the high voltage energy is located, said Dr. Ross.

He recommended following the American National Standards Institute's (ANSI) series of laser safety standards. The recommendations are recognized by many hospitals as the standard for guiding a laser safety program, he said.

Examples of ANSI standards include physicians acting as the safety officer, routine laser maintenance, and having a set of standard operating procedures that is kept on file. Recommendations are not just for large practices, Dr. Ross said. "Even a small clinic should have a laser safety officer."

Government safety standards for laser use are available from the Occupational Safety and Health Administration and the Food and Drug Administration's Center for Devices and Radiological Health. Having a sign posted near each device warning of potential hazards specific to that class of laser is an example of a government safety standard, he said.

There are four general safety categories for lasers:

Class 1. Low-power device that is considered safe.

Class 2. The eye blink response generally provides enough eye protection during use.

Class 3. Direct exposure of the eye to these medium-power devices has potential to cause harm.

Class 4. These high-power devices require the most caution to avoid eye and skin hazards through direct and reflected exposure. These lasers also can pose a fire hazard if nearby materials are accidentally ignited from direct or scattered beams.

Credentialing is another safety measure. All clinicians operating a laser at the Scripps Clinic, for example, must be credentialed for that specific device and wavelength. Requirements include some didactic training, supervision during three or more laser treatments, and hands-on instruction by the device manufacturer, Dr. Ross said.

As with most government standards, there is official terminology regarding laser safety. Maximal permissible exposure (MPE) is an official term, describing the amount of irradiance to which a patient can be exposed without causing eye or skin damage. It is important to note that patient discomfort is possible within the MPE limitations. The MPE is calculated using wavelength and duration of laser exposure.

Dermatologists can optimize safety with knowledge of the basic physics behind the energy delivered in laser light and how it provides benefits to the skin when delivered properly, he suggested.

Power delivered per unit area is called the irradiance. This is typically expressed as the power in watts per square centimeter. Many dermatologists and device manufacturers compare lasers and outcomes in terms of joules, which is the energy delivered per square centimeter.

On the patient end, science determines the depth to which laser light penetrates and is absorbed. This absorption coefficient varies among hemoglobin, melanin, and water, for example. Each component interacts to a different extent with laser energy, and dermatologists utilize this selective photothermolysis to optimize patient outcomes from laser treatments, he said.

Dr. Ross disclosed that he is a researcher for and receives funding from multiple laser companies, including Candela, Cutera, Lumenis, Sciton, and Syneron.

 

SDEF and this news organization are owned by Elsevier.

MIAMI - A considerable drop in patient wait time, less stress for the dermatologist, and an increase in revenue "more than pays for" hiring a physician extender, said Dr. Matthew J. Zirwas.

Photo courtesy Dr. Matthew J. Zirwas

Advice on how to hire the right person and how to staff the patch test protocol so patient satisfaction remains high was offered by Dr. Zirwas at the meeting. Sarah Otto, a certified nurse practitioner, also provided her perspective on working as Dr. Zirwas' physician extender.

"The best thing I've done as a patch tester is to bring Sarah on," said Dr. Zirwas of Ohio State University, Columbus. On average, patients wait 6.3 months for patch testing, based on 100 responses from American Contact Dermatitis Society members surveyed by Dr. Zirwas and his colleagues (Dermatitis 2010;21:98-101).

At Ohio State, the wait time for patch testing is 6-9 months, which, Dr. Zirwas said, "is really not acceptable for someone with an itchy rash."

"We were able to decrease [the average wait] from 6-9 months to 3 months," Ms. Otto said. At the same time, the average number of patients per week increased from 12 to 20.

"The additional revenue more than pays for the certified nurse practitioner," Dr. Zirwas said.

The study also showed that physicians used testing trays that contained an average of 62 allergens. Of the respondents, 68% used the North American Contact Dermatitis Group series, 94% reported using the Contact Allergen Replacement Database (CARD) test regularly, while only 9% used the thin-layer rapid-use epicutaneous (TRUE) test because of its low number of allergens. He and his colleagues concluded that CARD use should be encouraged.

After training with Dr. Zirwas in the clinic for 3 months, Ms. Otto began handling all initial patient consultations. "She leaves me more time to do the things I want to do," Dr. Zirwas said. "She really picks up a lot of … the things I don't like to do, for example, writing or sending letters."

He still sees all patch test patients, but is less stressed and has more fun at work now, he added.

"I take history and choose panels, and then present the patient to Dr. Zirwas," Ms. Otto said. "Dr. Zirwas adjusts the plan as needed."

Referring physician and patient acceptance of the physician extender was an initial concern, Dr. Zirwas said.

"We were worried patient satisfaction would be compromised because of less interaction with the physician." Ms. Otto said.

So they administered an internal patient satisfaction exit survey. They found, for example, that 94% of patients responded with a 4 or better (on a 1-5 scale) when asked, "Were you given enough time to explain your rash to the health care provider?" Also, 100% replied with a 4 or better when asked, "Did you have confidence in the knowledge of the health care provider(s) you saw today?"

"Based on these results, we did not think patient satisfaction had been impacted by my presence at Ohio State," Ms. Otto said.

Almost 30% of dermatologists currently work with a physician extender, including both nurse practitioners and physician assistants (J. Am. Acad. Dermatol. 2008;58:211-6).

Dr. Zirwas prefers nurse practitioners. "Nurse practitioners are nurses who have additional training so they can [make] independent medical decisions," he said. "Physician assistants are a little less trained in terms of making independent medical decisions, and are more trained to be an assistant to the physician than an independent provider."

Find someone who "enjoys working with the MD--I cannot emphasize this too much," Dr. Zirwas said. Also search for an extender who demonstrates a desire to learn new things, wants to grow professionally, and has at least several years of dermatology experience, he added. Ms. Otto had 3 years of previous general dermatology experience.

How much independence a physician extender should have is an unanswered question, Dr. Zirwas said. "When I'm out of town at a meeting, right now Sarah is not patch testing anyone. I think we will get to the point where internally referred patients can be patch tested by Sarah."

Disclosures: Dr. Zirwas and Ms. Otto had no relevant financial conflicts.

MIAMI - A considerable drop in patient wait time, less stress for the dermatologist, and an increase in revenue "more than pays for" hiring a physician extender, said Dr. Matthew J. Zirwas.

Photo courtesy Dr. Matthew J. Zirwas

Advice on how to hire the right person and how to staff the patch test protocol so patient satisfaction remains high was offered by Dr. Zirwas at the meeting. Sarah Otto, a certified nurse practitioner, also provided her perspective on working as Dr. Zirwas' physician extender.

"The best thing I've done as a patch tester is to bring Sarah on," said Dr. Zirwas of Ohio State University, Columbus. On average, patients wait 6.3 months for patch testing, based on 100 responses from American Contact Dermatitis Society members surveyed by Dr. Zirwas and his colleagues (Dermatitis 2010;21:98-101).

At Ohio State, the wait time for patch testing is 6-9 months, which, Dr. Zirwas said, "is really not acceptable for someone with an itchy rash."

"We were able to decrease [the average wait] from 6-9 months to 3 months," Ms. Otto said. At the same time, the average number of patients per week increased from 12 to 20.

"The additional revenue more than pays for the certified nurse practitioner," Dr. Zirwas said.

The study also showed that physicians used testing trays that contained an average of 62 allergens. Of the respondents, 68% used the North American Contact Dermatitis Group series, 94% reported using the Contact Allergen Replacement Database (CARD) test regularly, while only 9% used the thin-layer rapid-use epicutaneous (TRUE) test because of its low number of allergens. He and his colleagues concluded that CARD use should be encouraged.

After training with Dr. Zirwas in the clinic for 3 months, Ms. Otto began handling all initial patient consultations. "She leaves me more time to do the things I want to do," Dr. Zirwas said. "She really picks up a lot of … the things I don't like to do, for example, writing or sending letters."

He still sees all patch test patients, but is less stressed and has more fun at work now, he added.

"I take history and choose panels, and then present the patient to Dr. Zirwas," Ms. Otto said. "Dr. Zirwas adjusts the plan as needed."

Referring physician and patient acceptance of the physician extender was an initial concern, Dr. Zirwas said.

"We were worried patient satisfaction would be compromised because of less interaction with the physician." Ms. Otto said.

So they administered an internal patient satisfaction exit survey. They found, for example, that 94% of patients responded with a 4 or better (on a 1-5 scale) when asked, "Were you given enough time to explain your rash to the health care provider?" Also, 100% replied with a 4 or better when asked, "Did you have confidence in the knowledge of the health care provider(s) you saw today?"

"Based on these results, we did not think patient satisfaction had been impacted by my presence at Ohio State," Ms. Otto said.

Almost 30% of dermatologists currently work with a physician extender, including both nurse practitioners and physician assistants (J. Am. Acad. Dermatol. 2008;58:211-6).

Dr. Zirwas prefers nurse practitioners. "Nurse practitioners are nurses who have additional training so they can [make] independent medical decisions," he said. "Physician assistants are a little less trained in terms of making independent medical decisions, and are more trained to be an assistant to the physician than an independent provider."

Find someone who "enjoys working with the MD--I cannot emphasize this too much," Dr. Zirwas said. Also search for an extender who demonstrates a desire to learn new things, wants to grow professionally, and has at least several years of dermatology experience, he added. Ms. Otto had 3 years of previous general dermatology experience.

How much independence a physician extender should have is an unanswered question, Dr. Zirwas said. "When I'm out of town at a meeting, right now Sarah is not patch testing anyone. I think we will get to the point where internally referred patients can be patch tested by Sarah."

Disclosures: Dr. Zirwas and Ms. Otto had no relevant financial conflicts.

MIAMI - A considerable drop in patient wait time, less stress for the dermatologist, and an increase in revenue "more than pays for" hiring a physician extender, said Dr. Matthew J. Zirwas.

Photo courtesy Dr. Matthew J. Zirwas

Advice on how to hire the right person and how to staff the patch test protocol so patient satisfaction remains high was offered by Dr. Zirwas at the meeting. Sarah Otto, a certified nurse practitioner, also provided her perspective on working as Dr. Zirwas' physician extender.

"The best thing I've done as a patch tester is to bring Sarah on," said Dr. Zirwas of Ohio State University, Columbus. On average, patients wait 6.3 months for patch testing, based on 100 responses from American Contact Dermatitis Society members surveyed by Dr. Zirwas and his colleagues (Dermatitis 2010;21:98-101).

At Ohio State, the wait time for patch testing is 6-9 months, which, Dr. Zirwas said, "is really not acceptable for someone with an itchy rash."

"We were able to decrease [the average wait] from 6-9 months to 3 months," Ms. Otto said. At the same time, the average number of patients per week increased from 12 to 20.

"The additional revenue more than pays for the certified nurse practitioner," Dr. Zirwas said.

The study also showed that physicians used testing trays that contained an average of 62 allergens. Of the respondents, 68% used the North American Contact Dermatitis Group series, 94% reported using the Contact Allergen Replacement Database (CARD) test regularly, while only 9% used the thin-layer rapid-use epicutaneous (TRUE) test because of its low number of allergens. He and his colleagues concluded that CARD use should be encouraged.

After training with Dr. Zirwas in the clinic for 3 months, Ms. Otto began handling all initial patient consultations. "She leaves me more time to do the things I want to do," Dr. Zirwas said. "She really picks up a lot of … the things I don't like to do, for example, writing or sending letters."

He still sees all patch test patients, but is less stressed and has more fun at work now, he added.

"I take history and choose panels, and then present the patient to Dr. Zirwas," Ms. Otto said. "Dr. Zirwas adjusts the plan as needed."

Referring physician and patient acceptance of the physician extender was an initial concern, Dr. Zirwas said.

"We were worried patient satisfaction would be compromised because of less interaction with the physician." Ms. Otto said.

So they administered an internal patient satisfaction exit survey. They found, for example, that 94% of patients responded with a 4 or better (on a 1-5 scale) when asked, "Were you given enough time to explain your rash to the health care provider?" Also, 100% replied with a 4 or better when asked, "Did you have confidence in the knowledge of the health care provider(s) you saw today?"

"Based on these results, we did not think patient satisfaction had been impacted by my presence at Ohio State," Ms. Otto said.

Almost 30% of dermatologists currently work with a physician extender, including both nurse practitioners and physician assistants (J. Am. Acad. Dermatol. 2008;58:211-6).

Dr. Zirwas prefers nurse practitioners. "Nurse practitioners are nurses who have additional training so they can [make] independent medical decisions," he said. "Physician assistants are a little less trained in terms of making independent medical decisions, and are more trained to be an assistant to the physician than an independent provider."

Find someone who "enjoys working with the MD--I cannot emphasize this too much," Dr. Zirwas said. Also search for an extender who demonstrates a desire to learn new things, wants to grow professionally, and has at least several years of dermatology experience, he added. Ms. Otto had 3 years of previous general dermatology experience.

How much independence a physician extender should have is an unanswered question, Dr. Zirwas said. "When I'm out of town at a meeting, right now Sarah is not patch testing anyone. I think we will get to the point where internally referred patients can be patch tested by Sarah."

Disclosures: Dr. Zirwas and Ms. Otto had no relevant financial conflicts.

MIAMI - Patients with a strongly positive patch test result for the most common sensitizer in hair dye, para-phenylenediamine, also demonstrate cross-reactivity to some other hair dye components, according to a retrospective study.

"Basically we wanted to see if our 3+ reactors had strong cross-sensitivity to other compounds, versus our 1+ or 2+ positive PPD [para-phenylenediamine] patients." Dr. Lauren Fratesi said at the annual meeting of the American Contact Dermatitis Society.

Dr. Fratesi reviewed data for 134 patients with a PPD contact allergy. All patients had a significantly positive reaction (from 1+ to 3+) at an Ottawa outpatient contact dermatitis clinic between May 1997 and July 2009. The group was 76% female, and 13% were professional hairdressers.

Patients were assessed using 50-70 patch test allergens in the North American Contact Dermatitis Group standard series, as well as 7 allergens in the Chemotechnique hairdressing series. A total of 18% had a 1+ reaction, 19% had a 2+ reaction, and 63% had a 3+ reaction to PPD.

Slightly more than 90% were sensitized through hair dye; 2%, through henna tattoos; and 8%, from other sources of PPD. Not surprisingly, the face and neck were the most often affected areas, reported by 72% of the patients. A majority, 86%, used topical steroids to treat their allergic reactions. Oral corticosteroids were taken by 41%.

A significant relationship was found between the severity of the PPD reaction and cross-reactivity to other hair dyes, including 2,5-diaminotoluene (31% of patients) and 3-aminophenol (19%), said Dr. Fratesi, a dermatologist at the University of Ottawa.

In contrast, there was no significant relationship with prevalence of reactions to sulfa drugs (6%), benzocaine (8%), or black rubber/IPPD (N-isopropyl-N'-phenyl-paraphenylenediamine, 1.5%).

Dr. Fratesi reported no relevant financial disclosures.

MIAMI - Patients with a strongly positive patch test result for the most common sensitizer in hair dye, para-phenylenediamine, also demonstrate cross-reactivity to some other hair dye components, according to a retrospective study.

"Basically we wanted to see if our 3+ reactors had strong cross-sensitivity to other compounds, versus our 1+ or 2+ positive PPD [para-phenylenediamine] patients." Dr. Lauren Fratesi said at the annual meeting of the American Contact Dermatitis Society.

Dr. Fratesi reviewed data for 134 patients with a PPD contact allergy. All patients had a significantly positive reaction (from 1+ to 3+) at an Ottawa outpatient contact dermatitis clinic between May 1997 and July 2009. The group was 76% female, and 13% were professional hairdressers.

Patients were assessed using 50-70 patch test allergens in the North American Contact Dermatitis Group standard series, as well as 7 allergens in the Chemotechnique hairdressing series. A total of 18% had a 1+ reaction, 19% had a 2+ reaction, and 63% had a 3+ reaction to PPD.

Slightly more than 90% were sensitized through hair dye; 2%, through henna tattoos; and 8%, from other sources of PPD. Not surprisingly, the face and neck were the most often affected areas, reported by 72% of the patients. A majority, 86%, used topical steroids to treat their allergic reactions. Oral corticosteroids were taken by 41%.

A significant relationship was found between the severity of the PPD reaction and cross-reactivity to other hair dyes, including 2,5-diaminotoluene (31% of patients) and 3-aminophenol (19%), said Dr. Fratesi, a dermatologist at the University of Ottawa.

In contrast, there was no significant relationship with prevalence of reactions to sulfa drugs (6%), benzocaine (8%), or black rubber/IPPD (N-isopropyl-N'-phenyl-paraphenylenediamine, 1.5%).

Dr. Fratesi reported no relevant financial disclosures.

MIAMI - Patients with a strongly positive patch test result for the most common sensitizer in hair dye, para-phenylenediamine, also demonstrate cross-reactivity to some other hair dye components, according to a retrospective study.

"Basically we wanted to see if our 3+ reactors had strong cross-sensitivity to other compounds, versus our 1+ or 2+ positive PPD [para-phenylenediamine] patients." Dr. Lauren Fratesi said at the annual meeting of the American Contact Dermatitis Society.

Dr. Fratesi reviewed data for 134 patients with a PPD contact allergy. All patients had a significantly positive reaction (from 1+ to 3+) at an Ottawa outpatient contact dermatitis clinic between May 1997 and July 2009. The group was 76% female, and 13% were professional hairdressers.

Patients were assessed using 50-70 patch test allergens in the North American Contact Dermatitis Group standard series, as well as 7 allergens in the Chemotechnique hairdressing series. A total of 18% had a 1+ reaction, 19% had a 2+ reaction, and 63% had a 3+ reaction to PPD.

Slightly more than 90% were sensitized through hair dye; 2%, through henna tattoos; and 8%, from other sources of PPD. Not surprisingly, the face and neck were the most often affected areas, reported by 72% of the patients. A majority, 86%, used topical steroids to treat their allergic reactions. Oral corticosteroids were taken by 41%.

A significant relationship was found between the severity of the PPD reaction and cross-reactivity to other hair dyes, including 2,5-diaminotoluene (31% of patients) and 3-aminophenol (19%), said Dr. Fratesi, a dermatologist at the University of Ottawa.

In contrast, there was no significant relationship with prevalence of reactions to sulfa drugs (6%), benzocaine (8%), or black rubber/IPPD (N-isopropyl-N'-phenyl-paraphenylenediamine, 1.5%).

Dr. Fratesi reported no relevant financial disclosures.

MIAMI -- A computer-automated device detected melanoma and high-grade dysplastic nevi lesions with 98% sensitivity in a large, prospective, multicenter study.

The digital dermoscopy device "sees" at different skin depths using 10 spectral bands ranging from 430 nm to 950 nm. The technology, which was more than a decade in development, objectively assesses up to 75 factors to differentiate melanoma from low-grade and high-grade dysplastic nevi, Dr. Gary D. Monheit said.

"This is an adjunct [that] I think will be helpful in the dermatologist's office, both because of the manpower issue and the difficult lesions we see," Dr. Monheit (photographed on the left) said at the annual meeting of the American Academy of Dermatology.

Dr. Monheit was an investigator at one of seven sites that used the MelaFind (Electro-Optical Sciences) to assess a total of 1,632 evaluable lesions. Lesions included 70 invasive melanomas and 57 melanoma in situ. "This is the largest prospective, blinded study ever conducted in melanoma detection," he noted.

The noninvasive device has a handheld wand for image capture at the point of care. Because of these features and a proprietary algorithm that analyzes multiple spectrums, it is "totally objective with a yes or no algorithm for excision," said Dr. Monheit, a private practice dermatologist in Birmingham, Ala., and an associate clinical professor in the departments of dermatology and ophthalmology at the University of Alabama at Birmingham. Detection is automatic with immediate feedback, Dr. Monheit said. "If we don't get a clear image, the machine tells us the image is not possible." The technology was developed after assessment of more than 10,000 pigmented lesions from more than 7,000 patients.

The aim of this "pivotal study" was to establish safety of the device and sensitivity for melanoma detection. No adverse events were reported, Dr. Monheit said. Lesions had to be pigmented with melanin, keratin, and/or blood. Clinical management was biopsy, he added.

For melanoma and high-grade dysplastic nevi, the device had a 98% sensitivity. "These are the [lesions] you will want to take out," Dr. Monheit said.

"At same time we should look at specificity--we do not want to biopsy every lesion that comes into our office," Dr. Monheit said. The specificity of the device was 9.4%, statistically superior to the dermatologist evaluations at 3.7%.

The results with the device were compared with prebiopsy investigator diagnoses and with an objective pathologic review of lesions by a panel of three dermatopathologists. If two of the three dermatopathologists concurred on the diagnosis, their consensus was final. The device had a 98% sensitivity for biopsy detection.

Dr. Monheit and the other study investigators also collected patient data, including age, gender, ethnicity, patient in-house or referred, and any risk factors for melanoma. Anatomic locations of the lesions were also noted.
This study provides "evidence for safety and efficacy for aid in evaluating pigmented lesions," Dr. Monheit said.

Disclosures: Dr. Monheit is a consultant and researcher for Electro-Optical Sciences.

MIAMI -- A computer-automated device detected melanoma and high-grade dysplastic nevi lesions with 98% sensitivity in a large, prospective, multicenter study.

The digital dermoscopy device "sees" at different skin depths using 10 spectral bands ranging from 430 nm to 950 nm. The technology, which was more than a decade in development, objectively assesses up to 75 factors to differentiate melanoma from low-grade and high-grade dysplastic nevi, Dr. Gary D. Monheit said.

"This is an adjunct [that] I think will be helpful in the dermatologist's office, both because of the manpower issue and the difficult lesions we see," Dr. Monheit (photographed on the left) said at the annual meeting of the American Academy of Dermatology.

Dr. Monheit was an investigator at one of seven sites that used the MelaFind (Electro-Optical Sciences) to assess a total of 1,632 evaluable lesions. Lesions included 70 invasive melanomas and 57 melanoma in situ. "This is the largest prospective, blinded study ever conducted in melanoma detection," he noted.

The noninvasive device has a handheld wand for image capture at the point of care. Because of these features and a proprietary algorithm that analyzes multiple spectrums, it is "totally objective with a yes or no algorithm for excision," said Dr. Monheit, a private practice dermatologist in Birmingham, Ala., and an associate clinical professor in the departments of dermatology and ophthalmology at the University of Alabama at Birmingham. Detection is automatic with immediate feedback, Dr. Monheit said. "If we don't get a clear image, the machine tells us the image is not possible." The technology was developed after assessment of more than 10,000 pigmented lesions from more than 7,000 patients.

The aim of this "pivotal study" was to establish safety of the device and sensitivity for melanoma detection. No adverse events were reported, Dr. Monheit said. Lesions had to be pigmented with melanin, keratin, and/or blood. Clinical management was biopsy, he added.

For melanoma and high-grade dysplastic nevi, the device had a 98% sensitivity. "These are the [lesions] you will want to take out," Dr. Monheit said.

"At same time we should look at specificity--we do not want to biopsy every lesion that comes into our office," Dr. Monheit said. The specificity of the device was 9.4%, statistically superior to the dermatologist evaluations at 3.7%.

The results with the device were compared with prebiopsy investigator diagnoses and with an objective pathologic review of lesions by a panel of three dermatopathologists. If two of the three dermatopathologists concurred on the diagnosis, their consensus was final. The device had a 98% sensitivity for biopsy detection.

Dr. Monheit and the other study investigators also collected patient data, including age, gender, ethnicity, patient in-house or referred, and any risk factors for melanoma. Anatomic locations of the lesions were also noted.
This study provides "evidence for safety and efficacy for aid in evaluating pigmented lesions," Dr. Monheit said.

Disclosures: Dr. Monheit is a consultant and researcher for Electro-Optical Sciences.

MIAMI -- A computer-automated device detected melanoma and high-grade dysplastic nevi lesions with 98% sensitivity in a large, prospective, multicenter study.

The digital dermoscopy device "sees" at different skin depths using 10 spectral bands ranging from 430 nm to 950 nm. The technology, which was more than a decade in development, objectively assesses up to 75 factors to differentiate melanoma from low-grade and high-grade dysplastic nevi, Dr. Gary D. Monheit said.

"This is an adjunct [that] I think will be helpful in the dermatologist's office, both because of the manpower issue and the difficult lesions we see," Dr. Monheit (photographed on the left) said at the annual meeting of the American Academy of Dermatology.

Dr. Monheit was an investigator at one of seven sites that used the MelaFind (Electro-Optical Sciences) to assess a total of 1,632 evaluable lesions. Lesions included 70 invasive melanomas and 57 melanoma in situ. "This is the largest prospective, blinded study ever conducted in melanoma detection," he noted.

The noninvasive device has a handheld wand for image capture at the point of care. Because of these features and a proprietary algorithm that analyzes multiple spectrums, it is "totally objective with a yes or no algorithm for excision," said Dr. Monheit, a private practice dermatologist in Birmingham, Ala., and an associate clinical professor in the departments of dermatology and ophthalmology at the University of Alabama at Birmingham. Detection is automatic with immediate feedback, Dr. Monheit said. "If we don't get a clear image, the machine tells us the image is not possible." The technology was developed after assessment of more than 10,000 pigmented lesions from more than 7,000 patients.

The aim of this "pivotal study" was to establish safety of the device and sensitivity for melanoma detection. No adverse events were reported, Dr. Monheit said. Lesions had to be pigmented with melanin, keratin, and/or blood. Clinical management was biopsy, he added.

For melanoma and high-grade dysplastic nevi, the device had a 98% sensitivity. "These are the [lesions] you will want to take out," Dr. Monheit said.

"At same time we should look at specificity--we do not want to biopsy every lesion that comes into our office," Dr. Monheit said. The specificity of the device was 9.4%, statistically superior to the dermatologist evaluations at 3.7%.

The results with the device were compared with prebiopsy investigator diagnoses and with an objective pathologic review of lesions by a panel of three dermatopathologists. If two of the three dermatopathologists concurred on the diagnosis, their consensus was final. The device had a 98% sensitivity for biopsy detection.

Dr. Monheit and the other study investigators also collected patient data, including age, gender, ethnicity, patient in-house or referred, and any risk factors for melanoma. Anatomic locations of the lesions were also noted.
This study provides "evidence for safety and efficacy for aid in evaluating pigmented lesions," Dr. Monheit said.

Disclosures: Dr. Monheit is a consultant and researcher for Electro-Optical Sciences.

MIAMI BEACH — Most critical care patients experience at least 20 “handoffs” during their average 4-day hospital stay—handoffs that are “major opportunities for miscommunication” that can lead to errors, Dr. Andrew Shorr said.

“These handoffs happen routinely, and we have little published evidence about them…. If this were going to be an evidence-based talk, I could sit down right now,” he said at the annual congress of the Society of Critical Care Medicine.

He calculated the scope of the ICU problem as follows: two physician handoffs and three nursing handoffs per day, multiplied by four for the average length of stay, equals at least 20 handoffs. “And that is likely a conservative estimate,” he said.

Physicians “don't know any systematic way to do this,” said Dr. Shorr, associate section director of pulmonary critical care, Washington (D.C.) Hospital Center, and a member of the medicine faculty at Georgetown University.

The complexity of ICU care is one challenge: In a study, a checklist developed by surgeons worked well for handoffs in all hospital settings except critical care (J. Surg. Educ. 2008;65:476–85).

The noise level and degree of privacy also can play a role. “If this is in a busy cafeteria while someone is grabbing coffee and about to leave, [the handoff] is probably not going to go well,” Dr. Shorr said.

Moreover, there is no standard definition of an effective handoff, he said. A handoff should involve interactive, up-to-date communication that employs repeat and read-back techniques, according to the Joint Commission's National Patient Safety Goals. “I've never seen that in the ICU,” he said.

In addition, about one-third of malpractice claim reviews involve communication errors, and 40% of those refer to patient handoffs, Dr. Shorr said. A prospective study is needed to determine the most effective system for handoffs in the critical care setting, he said.

Disclosures: Dr. Shore had no relevant financial relationships.

MIAMI BEACH — Most critical care patients experience at least 20 “handoffs” during their average 4-day hospital stay—handoffs that are “major opportunities for miscommunication” that can lead to errors, Dr. Andrew Shorr said.

“These handoffs happen routinely, and we have little published evidence about them…. If this were going to be an evidence-based talk, I could sit down right now,” he said at the annual congress of the Society of Critical Care Medicine.

He calculated the scope of the ICU problem as follows: two physician handoffs and three nursing handoffs per day, multiplied by four for the average length of stay, equals at least 20 handoffs. “And that is likely a conservative estimate,” he said.

Physicians “don't know any systematic way to do this,” said Dr. Shorr, associate section director of pulmonary critical care, Washington (D.C.) Hospital Center, and a member of the medicine faculty at Georgetown University.

The complexity of ICU care is one challenge: In a study, a checklist developed by surgeons worked well for handoffs in all hospital settings except critical care (J. Surg. Educ. 2008;65:476–85).

The noise level and degree of privacy also can play a role. “If this is in a busy cafeteria while someone is grabbing coffee and about to leave, [the handoff] is probably not going to go well,” Dr. Shorr said.

Moreover, there is no standard definition of an effective handoff, he said. A handoff should involve interactive, up-to-date communication that employs repeat and read-back techniques, according to the Joint Commission's National Patient Safety Goals. “I've never seen that in the ICU,” he said.

In addition, about one-third of malpractice claim reviews involve communication errors, and 40% of those refer to patient handoffs, Dr. Shorr said. A prospective study is needed to determine the most effective system for handoffs in the critical care setting, he said.

Disclosures: Dr. Shore had no relevant financial relationships.

MIAMI BEACH — Most critical care patients experience at least 20 “handoffs” during their average 4-day hospital stay—handoffs that are “major opportunities for miscommunication” that can lead to errors, Dr. Andrew Shorr said.

“These handoffs happen routinely, and we have little published evidence about them…. If this were going to be an evidence-based talk, I could sit down right now,” he said at the annual congress of the Society of Critical Care Medicine.

He calculated the scope of the ICU problem as follows: two physician handoffs and three nursing handoffs per day, multiplied by four for the average length of stay, equals at least 20 handoffs. “And that is likely a conservative estimate,” he said.

Physicians “don't know any systematic way to do this,” said Dr. Shorr, associate section director of pulmonary critical care, Washington (D.C.) Hospital Center, and a member of the medicine faculty at Georgetown University.

The complexity of ICU care is one challenge: In a study, a checklist developed by surgeons worked well for handoffs in all hospital settings except critical care (J. Surg. Educ. 2008;65:476–85).

The noise level and degree of privacy also can play a role. “If this is in a busy cafeteria while someone is grabbing coffee and about to leave, [the handoff] is probably not going to go well,” Dr. Shorr said.

Moreover, there is no standard definition of an effective handoff, he said. A handoff should involve interactive, up-to-date communication that employs repeat and read-back techniques, according to the Joint Commission's National Patient Safety Goals. “I've never seen that in the ICU,” he said.

In addition, about one-third of malpractice claim reviews involve communication errors, and 40% of those refer to patient handoffs, Dr. Shorr said. A prospective study is needed to determine the most effective system for handoffs in the critical care setting, he said.

Disclosures: Dr. Shore had no relevant financial relationships.

MIAMI — Varying degrees of success and some caveats come with the use of probiotics to combat or prevent Clostridium difficile infection and antibiotic-associated diarrhea.

Saccharomyces boulardii, lactobacilli, and bifidobacteria are among the better-studied probiotic options for these purposes, Dr. Curtis Danskey said at the International Probiotics Association World Congress.

Many hospitalized patients do not have normal gut flora, but “if we can restore the normal intestinal flora, an effective probiotic may protect [these] patients,” said Dr. Danskey, who is on the medicine faculty at Louis Stokes Cleveland VA Medical Center.

C. difficile can cause up to 30% of nosocomial diarrhea cases in hospitalized patients (Pol. J. Microbiol. 2005;54:111–5). In addition, antibiotic-associated diarrhea (AAD) occurs in 3%–29% of hospitalized patients and is associated with increased length of stay and costs (J. Hosp. Infect. 2003;54:202–6).

The antibiotics routinely prescribed to fight C. difficile also kill beneficial flora in the gut, which is where probiotic therapy might help. “There is evidence [supporting the] use of probiotics for antibiotic-associated diarrhea if you want to use them,” Dr. Danskey said.

▸ Saccharomyces boulardii. This organism is a type of yeast and is “probably one of the most well-studied probiotics for C. difficile,” Dr. Danskey said. In one study, patients with C. difficile disease experienced a significant reduction in recurrences when treated with high-dose vancomycin for 10 days followed by S. boulardii for 28 days, compared with a regimen of vancomycin followed by placebo (Clin. Infect. Dis. 2000;31:1012–7).

On the downside, there have been several reports of fungemia associated with S. boulardii treatment, particularly in immunocompromised patients, Dr. Danskey said (Crit. Care 2008;12:414). There is a risk of transfer of fungemia to adjacent patients, so “I will not use it in my ICU, [but I] may use it in an outpatient setting in someone with recurrent infections,” he added.

▸ Lactobacilli and bifidobacteria. There is some rationale for use of these two probiotic species to prevent C. difficile infection, Dr. Danskey said. Lactobacilli, for example, can inhibit growth of C. difficile in vitro (J. Med. Microbiol. 2004;53:551–4). Also, reduced lactobacilli levels were found in the stool of hospitalized patients with C. difficile (Clin. Infect. Dis. 1997;25[suppl 2]:S189–90). “A lack of these organisms may allow C. difficile to grow.”

Historically, the numbers have been small in many probiotic trials that did not show a reduction in C. difficile infection. “Up to 2005, the data were not very convincing,” Dr. Danskey said.

After that, reports became more robust. For example, in one study, 135 hospitalized patients aged 50 years and older taking antibiotics were randomized to a lactobacillus preparation or placebo (BMJ 2007;335:80). A total of 12% of the probiotic group developed AAD, compared with 34% of placebo patients. In addition, no patient who took the probiotic developed a C. difficile infection vs. 17% of the placebo group.

“The results looked very impressive,” Dr. Danskey said. However, the study received a fair amount of criticism. For example, the placebo group drank a sterile milkshake, which could have caused diarrhea, some said. Other aspects of the study that drew criticism included the highly selected patient population (only 8% of screened patients were enrolled) and the exclusion of patients taking antibiotics most likely to cause diarrhea.

“However, the 8% rate is still higher than a just-published study [of monoclonal antibodies targeted against C. difficile toxins] that only enrolled 3% of screened patients,” Dr. Danskey said (N. Engl. J. Med. 2010;362:197–205). Also, in the 2007 lactobacillus study, 43 of 69 probiotic-treated patients (62%) received a high-risk antibiotic, as did 46 of the 66 placebo patients (70%), he said.

In terms of potential adverse events, there are some concerns about safety, “although we eat yogurt [with lactobacillus species] all the time,” Dr. Danskey said. For example, researchers reported two cases of sepsis associated with probiotic lactobacillus strains (Pediatrics 2005;115:178–810). He also cited a meta-analysis of the advantages and disadvantages of probiotics for AAD and C. difficile infection (Anaerobe 2009;15:274–80).

▸ Nontoxigenic probiotics. Normally, C. difficile growth and toxin production start shortly after infection in susceptible individuals. A person can be an asymptomatic carrier, but about one-third of patients develop disease, Dr. Danskey said. When this happens, C. difficile toxins bind to the lining of the GI tract, leading to cell death and significant inflammation. Colonoscopy and sigmoidoscopy often show pseudomembranous colitis in these patients.

Nontoxigenic probiotics that compete with C. difficile are in development. “Evidence suggests patients colonized with nontoxigenic strains were protected from infection with toxigenic strains,” Dr. Danskey said. “This makes logical sense—they will compete with toxigenic strains in the GI system.” So far, the evidence primarily comes from animal research. “It is now in phase I trials in patients and will move forward if it is shown to be effective and safe.”

 

Disclosures: Dr. Danskey receives research support from Viral Pharma (which is developing nontoxigenic probiotic strains) and the Department of Veterans Affairs.

Document

70119_fx1.sml

'There is evidence [supporting the] use of probiotics for antibiotic-associated diarrhea if you want to use them.'

Source DR. DANSKEY

MIAMI — Varying degrees of success and some caveats come with the use of probiotics to combat or prevent Clostridium difficile infection and antibiotic-associated diarrhea.

Saccharomyces boulardii, lactobacilli, and bifidobacteria are among the better-studied probiotic options for these purposes, Dr. Curtis Danskey said at the International Probiotics Association World Congress.

Many hospitalized patients do not have normal gut flora, but “if we can restore the normal intestinal flora, an effective probiotic may protect [these] patients,” said Dr. Danskey, who is on the medicine faculty at Louis Stokes Cleveland VA Medical Center.

C. difficile can cause up to 30% of nosocomial diarrhea cases in hospitalized patients (Pol. J. Microbiol. 2005;54:111–5). In addition, antibiotic-associated diarrhea (AAD) occurs in 3%–29% of hospitalized patients and is associated with increased length of stay and costs (J. Hosp. Infect. 2003;54:202–6).

The antibiotics routinely prescribed to fight C. difficile also kill beneficial flora in the gut, which is where probiotic therapy might help. “There is evidence [supporting the] use of probiotics for antibiotic-associated diarrhea if you want to use them,” Dr. Danskey said.

▸ Saccharomyces boulardii. This organism is a type of yeast and is “probably one of the most well-studied probiotics for C. difficile,” Dr. Danskey said. In one study, patients with C. difficile disease experienced a significant reduction in recurrences when treated with high-dose vancomycin for 10 days followed by S. boulardii for 28 days, compared with a regimen of vancomycin followed by placebo (Clin. Infect. Dis. 2000;31:1012–7).

On the downside, there have been several reports of fungemia associated with S. boulardii treatment, particularly in immunocompromised patients, Dr. Danskey said (Crit. Care 2008;12:414). There is a risk of transfer of fungemia to adjacent patients, so “I will not use it in my ICU, [but I] may use it in an outpatient setting in someone with recurrent infections,” he added.

▸ Lactobacilli and bifidobacteria. There is some rationale for use of these two probiotic species to prevent C. difficile infection, Dr. Danskey said. Lactobacilli, for example, can inhibit growth of C. difficile in vitro (J. Med. Microbiol. 2004;53:551–4). Also, reduced lactobacilli levels were found in the stool of hospitalized patients with C. difficile (Clin. Infect. Dis. 1997;25[suppl 2]:S189–90). “A lack of these organisms may allow C. difficile to grow.”

Historically, the numbers have been small in many probiotic trials that did not show a reduction in C. difficile infection. “Up to 2005, the data were not very convincing,” Dr. Danskey said.

After that, reports became more robust. For example, in one study, 135 hospitalized patients aged 50 years and older taking antibiotics were randomized to a lactobacillus preparation or placebo (BMJ 2007;335:80). A total of 12% of the probiotic group developed AAD, compared with 34% of placebo patients. In addition, no patient who took the probiotic developed a C. difficile infection vs. 17% of the placebo group.

“The results looked very impressive,” Dr. Danskey said. However, the study received a fair amount of criticism. For example, the placebo group drank a sterile milkshake, which could have caused diarrhea, some said. Other aspects of the study that drew criticism included the highly selected patient population (only 8% of screened patients were enrolled) and the exclusion of patients taking antibiotics most likely to cause diarrhea.

“However, the 8% rate is still higher than a just-published study [of monoclonal antibodies targeted against C. difficile toxins] that only enrolled 3% of screened patients,” Dr. Danskey said (N. Engl. J. Med. 2010;362:197–205). Also, in the 2007 lactobacillus study, 43 of 69 probiotic-treated patients (62%) received a high-risk antibiotic, as did 46 of the 66 placebo patients (70%), he said.

In terms of potential adverse events, there are some concerns about safety, “although we eat yogurt [with lactobacillus species] all the time,” Dr. Danskey said. For example, researchers reported two cases of sepsis associated with probiotic lactobacillus strains (Pediatrics 2005;115:178–810). He also cited a meta-analysis of the advantages and disadvantages of probiotics for AAD and C. difficile infection (Anaerobe 2009;15:274–80).

▸ Nontoxigenic probiotics. Normally, C. difficile growth and toxin production start shortly after infection in susceptible individuals. A person can be an asymptomatic carrier, but about one-third of patients develop disease, Dr. Danskey said. When this happens, C. difficile toxins bind to the lining of the GI tract, leading to cell death and significant inflammation. Colonoscopy and sigmoidoscopy often show pseudomembranous colitis in these patients.

Nontoxigenic probiotics that compete with C. difficile are in development. “Evidence suggests patients colonized with nontoxigenic strains were protected from infection with toxigenic strains,” Dr. Danskey said. “This makes logical sense—they will compete with toxigenic strains in the GI system.” So far, the evidence primarily comes from animal research. “It is now in phase I trials in patients and will move forward if it is shown to be effective and safe.”

 

Disclosures: Dr. Danskey receives research support from Viral Pharma (which is developing nontoxigenic probiotic strains) and the Department of Veterans Affairs.

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'There is evidence [supporting the] use of probiotics for antibiotic-associated diarrhea if you want to use them.'

Source DR. DANSKEY

MIAMI — Varying degrees of success and some caveats come with the use of probiotics to combat or prevent Clostridium difficile infection and antibiotic-associated diarrhea.

Saccharomyces boulardii, lactobacilli, and bifidobacteria are among the better-studied probiotic options for these purposes, Dr. Curtis Danskey said at the International Probiotics Association World Congress.

Many hospitalized patients do not have normal gut flora, but “if we can restore the normal intestinal flora, an effective probiotic may protect [these] patients,” said Dr. Danskey, who is on the medicine faculty at Louis Stokes Cleveland VA Medical Center.

C. difficile can cause up to 30% of nosocomial diarrhea cases in hospitalized patients (Pol. J. Microbiol. 2005;54:111–5). In addition, antibiotic-associated diarrhea (AAD) occurs in 3%–29% of hospitalized patients and is associated with increased length of stay and costs (J. Hosp. Infect. 2003;54:202–6).

The antibiotics routinely prescribed to fight C. difficile also kill beneficial flora in the gut, which is where probiotic therapy might help. “There is evidence [supporting the] use of probiotics for antibiotic-associated diarrhea if you want to use them,” Dr. Danskey said.

▸ Saccharomyces boulardii. This organism is a type of yeast and is “probably one of the most well-studied probiotics for C. difficile,” Dr. Danskey said. In one study, patients with C. difficile disease experienced a significant reduction in recurrences when treated with high-dose vancomycin for 10 days followed by S. boulardii for 28 days, compared with a regimen of vancomycin followed by placebo (Clin. Infect. Dis. 2000;31:1012–7).

On the downside, there have been several reports of fungemia associated with S. boulardii treatment, particularly in immunocompromised patients, Dr. Danskey said (Crit. Care 2008;12:414). There is a risk of transfer of fungemia to adjacent patients, so “I will not use it in my ICU, [but I] may use it in an outpatient setting in someone with recurrent infections,” he added.

▸ Lactobacilli and bifidobacteria. There is some rationale for use of these two probiotic species to prevent C. difficile infection, Dr. Danskey said. Lactobacilli, for example, can inhibit growth of C. difficile in vitro (J. Med. Microbiol. 2004;53:551–4). Also, reduced lactobacilli levels were found in the stool of hospitalized patients with C. difficile (Clin. Infect. Dis. 1997;25[suppl 2]:S189–90). “A lack of these organisms may allow C. difficile to grow.”

Historically, the numbers have been small in many probiotic trials that did not show a reduction in C. difficile infection. “Up to 2005, the data were not very convincing,” Dr. Danskey said.

After that, reports became more robust. For example, in one study, 135 hospitalized patients aged 50 years and older taking antibiotics were randomized to a lactobacillus preparation or placebo (BMJ 2007;335:80). A total of 12% of the probiotic group developed AAD, compared with 34% of placebo patients. In addition, no patient who took the probiotic developed a C. difficile infection vs. 17% of the placebo group.

“The results looked very impressive,” Dr. Danskey said. However, the study received a fair amount of criticism. For example, the placebo group drank a sterile milkshake, which could have caused diarrhea, some said. Other aspects of the study that drew criticism included the highly selected patient population (only 8% of screened patients were enrolled) and the exclusion of patients taking antibiotics most likely to cause diarrhea.

“However, the 8% rate is still higher than a just-published study [of monoclonal antibodies targeted against C. difficile toxins] that only enrolled 3% of screened patients,” Dr. Danskey said (N. Engl. J. Med. 2010;362:197–205). Also, in the 2007 lactobacillus study, 43 of 69 probiotic-treated patients (62%) received a high-risk antibiotic, as did 46 of the 66 placebo patients (70%), he said.

In terms of potential adverse events, there are some concerns about safety, “although we eat yogurt [with lactobacillus species] all the time,” Dr. Danskey said. For example, researchers reported two cases of sepsis associated with probiotic lactobacillus strains (Pediatrics 2005;115:178–810). He also cited a meta-analysis of the advantages and disadvantages of probiotics for AAD and C. difficile infection (Anaerobe 2009;15:274–80).

▸ Nontoxigenic probiotics. Normally, C. difficile growth and toxin production start shortly after infection in susceptible individuals. A person can be an asymptomatic carrier, but about one-third of patients develop disease, Dr. Danskey said. When this happens, C. difficile toxins bind to the lining of the GI tract, leading to cell death and significant inflammation. Colonoscopy and sigmoidoscopy often show pseudomembranous colitis in these patients.

Nontoxigenic probiotics that compete with C. difficile are in development. “Evidence suggests patients colonized with nontoxigenic strains were protected from infection with toxigenic strains,” Dr. Danskey said. “This makes logical sense—they will compete with toxigenic strains in the GI system.” So far, the evidence primarily comes from animal research. “It is now in phase I trials in patients and will move forward if it is shown to be effective and safe.”

 

Disclosures: Dr. Danskey receives research support from Viral Pharma (which is developing nontoxigenic probiotic strains) and the Department of Veterans Affairs.

Document

70119_fx1.sml

'There is evidence [supporting the] use of probiotics for antibiotic-associated diarrhea if you want to use them.'

Source DR. DANSKEY