Fractional Laser Side Effect Risk Low, Study Finds

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CHICAGO — Fractional laser photothermolysis should be considered first-line therapy for cutaneous resurfacing because of the device's efficacy in treating a wide range of skin types with minimal adverse events.

"There is a very low complication rate, compared with other ablative laser methods such as the carbon dioxide and erbium lasers. The most common side effect in our study was acneiform eruption, which occurred less than 2% of the time," said Dr. Emmy Graber at the annual meeting of the American Society for Dermatologic Surgery.

Acne-prone patients were more likely to experience posttreatment acne in a study conducted by Dr. Graber and colleagues. Use of oral antibiotics (doxycycline 20 mg b.i.d.) during subsequent treatments prevented further outbreaks.

Treatment with fractional lasers has been shown to be effective for the treatment of photodamaged skin and fresh scars. However, there are limited studies evaluating the side effects and complications of the technique. "This is the first large-scale study to evaluate complications with the Fraxel laser," said Dr. Graber, a fellow at the Washington (D.C.) Institute of Dermatologic Laser Surgery.

The investigators conducted a retrospective chart study of 961 treatments using a 1,550-nm erbium-doped fiber laser (Fraxel, Reliant Technologies Inc.). Dr. Graber, now with SkinCare Physicians in Chestnut Hill, Mass., declared no financial conflicts and said the study received no funding or equipment from Reliant.

The study included 422 patients with skin types I-IV treated by two operators between October 2004 and September 2006.

"All treatments were done with either the Fraxel 1 or Fraxel 2 using the 15-mm handpiece with a fluence range from 10 to 40 J/cm2, and the average fluence used was 25 J," she said, adding that densities ranged from 125 to 250 microscopic treatment zones per square centimeter, and average total delivered energy per treatment was 4.2 kJ.

All study patients were telephoned by a nurse 1 day after treatment and all had follow-up visits at 1 month. Most patients were followed for at least 1 year after final treatment, Dr. Graber said.

Most of those treated were women (91%) and most treatments were performed on the face (74%). Nearly one-fourth of patients were treated on both the face and other parts of the body. The majority of treatments (743) were for photodamage. The remaining treatments were for scars (175) and other diagnoses (43).

Overall, the 961 treatments resulted in 73 complications, which included acneiform eruptions (18), herpes simplex virus outbreak (17), erosions (13), prolonged erythema (8), postinflammatory hyperpigmentation (7), prolonged edema (6), dermatitis (2), impetigo (1), and purpura (1).

The side effect rate did not differ with regard to gender, age, body location, or diagnosis, Dr. Graber said.

"Those with complications had significantly darker skin types, and this discrepancy was most evident when comparing the incidence of postinflammatory hyperpigmentation, which appeared an average of 11 days post treatment and lasted an average of 50 days, which was longer than any other complication," Dr. Graber said.

In addition, 27% (259) of the 961 treatments were on patients with histories of herpes simplex virus (HSV). One-third of these patients (86) received antiviral prophylaxis, and 6 developed an HSV outbreak despite prophylaxis. Of the remaining two-thirds who did not receive prophylaxis, eight developed an HSV outbreak, she said, adding that of the 702 treatments on patients without histories of HSV, 3 resulted in HSV outbreak.

Because the complication rate in darker-skinned patients was low, pretreatment of all Fraxel patients with hydroquinones or other lighteners is not recommended, said study coauthor Dr. Tina Alster, the institute's director. "If you see a problem postoperatively, you can try to fade it out then, but in our study of close to a thousand treatments, the number of complications was virtually nil," Dr. Alster said, adding that the treatment should be avoided in tanned skin.

Fraxel 1, now called the Fraxel 750, received Food and Drug Administration approval in November 2003, according to a company spokesperson. The second-generation Fraxel 2, which has an adjustable spot-size feature, was approved last year.

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CHICAGO — Fractional laser photothermolysis should be considered first-line therapy for cutaneous resurfacing because of the device's efficacy in treating a wide range of skin types with minimal adverse events.

"There is a very low complication rate, compared with other ablative laser methods such as the carbon dioxide and erbium lasers. The most common side effect in our study was acneiform eruption, which occurred less than 2% of the time," said Dr. Emmy Graber at the annual meeting of the American Society for Dermatologic Surgery.

Acne-prone patients were more likely to experience posttreatment acne in a study conducted by Dr. Graber and colleagues. Use of oral antibiotics (doxycycline 20 mg b.i.d.) during subsequent treatments prevented further outbreaks.

Treatment with fractional lasers has been shown to be effective for the treatment of photodamaged skin and fresh scars. However, there are limited studies evaluating the side effects and complications of the technique. "This is the first large-scale study to evaluate complications with the Fraxel laser," said Dr. Graber, a fellow at the Washington (D.C.) Institute of Dermatologic Laser Surgery.

The investigators conducted a retrospective chart study of 961 treatments using a 1,550-nm erbium-doped fiber laser (Fraxel, Reliant Technologies Inc.). Dr. Graber, now with SkinCare Physicians in Chestnut Hill, Mass., declared no financial conflicts and said the study received no funding or equipment from Reliant.

The study included 422 patients with skin types I-IV treated by two operators between October 2004 and September 2006.

"All treatments were done with either the Fraxel 1 or Fraxel 2 using the 15-mm handpiece with a fluence range from 10 to 40 J/cm2, and the average fluence used was 25 J," she said, adding that densities ranged from 125 to 250 microscopic treatment zones per square centimeter, and average total delivered energy per treatment was 4.2 kJ.

All study patients were telephoned by a nurse 1 day after treatment and all had follow-up visits at 1 month. Most patients were followed for at least 1 year after final treatment, Dr. Graber said.

Most of those treated were women (91%) and most treatments were performed on the face (74%). Nearly one-fourth of patients were treated on both the face and other parts of the body. The majority of treatments (743) were for photodamage. The remaining treatments were for scars (175) and other diagnoses (43).

Overall, the 961 treatments resulted in 73 complications, which included acneiform eruptions (18), herpes simplex virus outbreak (17), erosions (13), prolonged erythema (8), postinflammatory hyperpigmentation (7), prolonged edema (6), dermatitis (2), impetigo (1), and purpura (1).

The side effect rate did not differ with regard to gender, age, body location, or diagnosis, Dr. Graber said.

"Those with complications had significantly darker skin types, and this discrepancy was most evident when comparing the incidence of postinflammatory hyperpigmentation, which appeared an average of 11 days post treatment and lasted an average of 50 days, which was longer than any other complication," Dr. Graber said.

In addition, 27% (259) of the 961 treatments were on patients with histories of herpes simplex virus (HSV). One-third of these patients (86) received antiviral prophylaxis, and 6 developed an HSV outbreak despite prophylaxis. Of the remaining two-thirds who did not receive prophylaxis, eight developed an HSV outbreak, she said, adding that of the 702 treatments on patients without histories of HSV, 3 resulted in HSV outbreak.

Because the complication rate in darker-skinned patients was low, pretreatment of all Fraxel patients with hydroquinones or other lighteners is not recommended, said study coauthor Dr. Tina Alster, the institute's director. "If you see a problem postoperatively, you can try to fade it out then, but in our study of close to a thousand treatments, the number of complications was virtually nil," Dr. Alster said, adding that the treatment should be avoided in tanned skin.

Fraxel 1, now called the Fraxel 750, received Food and Drug Administration approval in November 2003, according to a company spokesperson. The second-generation Fraxel 2, which has an adjustable spot-size feature, was approved last year.

CHICAGO — Fractional laser photothermolysis should be considered first-line therapy for cutaneous resurfacing because of the device's efficacy in treating a wide range of skin types with minimal adverse events.

"There is a very low complication rate, compared with other ablative laser methods such as the carbon dioxide and erbium lasers. The most common side effect in our study was acneiform eruption, which occurred less than 2% of the time," said Dr. Emmy Graber at the annual meeting of the American Society for Dermatologic Surgery.

Acne-prone patients were more likely to experience posttreatment acne in a study conducted by Dr. Graber and colleagues. Use of oral antibiotics (doxycycline 20 mg b.i.d.) during subsequent treatments prevented further outbreaks.

Treatment with fractional lasers has been shown to be effective for the treatment of photodamaged skin and fresh scars. However, there are limited studies evaluating the side effects and complications of the technique. "This is the first large-scale study to evaluate complications with the Fraxel laser," said Dr. Graber, a fellow at the Washington (D.C.) Institute of Dermatologic Laser Surgery.

The investigators conducted a retrospective chart study of 961 treatments using a 1,550-nm erbium-doped fiber laser (Fraxel, Reliant Technologies Inc.). Dr. Graber, now with SkinCare Physicians in Chestnut Hill, Mass., declared no financial conflicts and said the study received no funding or equipment from Reliant.

The study included 422 patients with skin types I-IV treated by two operators between October 2004 and September 2006.

"All treatments were done with either the Fraxel 1 or Fraxel 2 using the 15-mm handpiece with a fluence range from 10 to 40 J/cm2, and the average fluence used was 25 J," she said, adding that densities ranged from 125 to 250 microscopic treatment zones per square centimeter, and average total delivered energy per treatment was 4.2 kJ.

All study patients were telephoned by a nurse 1 day after treatment and all had follow-up visits at 1 month. Most patients were followed for at least 1 year after final treatment, Dr. Graber said.

Most of those treated were women (91%) and most treatments were performed on the face (74%). Nearly one-fourth of patients were treated on both the face and other parts of the body. The majority of treatments (743) were for photodamage. The remaining treatments were for scars (175) and other diagnoses (43).

Overall, the 961 treatments resulted in 73 complications, which included acneiform eruptions (18), herpes simplex virus outbreak (17), erosions (13), prolonged erythema (8), postinflammatory hyperpigmentation (7), prolonged edema (6), dermatitis (2), impetigo (1), and purpura (1).

The side effect rate did not differ with regard to gender, age, body location, or diagnosis, Dr. Graber said.

"Those with complications had significantly darker skin types, and this discrepancy was most evident when comparing the incidence of postinflammatory hyperpigmentation, which appeared an average of 11 days post treatment and lasted an average of 50 days, which was longer than any other complication," Dr. Graber said.

In addition, 27% (259) of the 961 treatments were on patients with histories of herpes simplex virus (HSV). One-third of these patients (86) received antiviral prophylaxis, and 6 developed an HSV outbreak despite prophylaxis. Of the remaining two-thirds who did not receive prophylaxis, eight developed an HSV outbreak, she said, adding that of the 702 treatments on patients without histories of HSV, 3 resulted in HSV outbreak.

Because the complication rate in darker-skinned patients was low, pretreatment of all Fraxel patients with hydroquinones or other lighteners is not recommended, said study coauthor Dr. Tina Alster, the institute's director. "If you see a problem postoperatively, you can try to fade it out then, but in our study of close to a thousand treatments, the number of complications was virtually nil," Dr. Alster said, adding that the treatment should be avoided in tanned skin.

Fraxel 1, now called the Fraxel 750, received Food and Drug Administration approval in November 2003, according to a company spokesperson. The second-generation Fraxel 2, which has an adjustable spot-size feature, was approved last year.

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'Young-Onset' Alzheimer's Is Increasing

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CHICAGO — The increasing incidence of early-onset dementia represents both a national challenge and a future crisis, according to the Alzheimer's Association, which is about to change the designation to “young-onset.”

Data from the national Health and Retirement Study indicate that in 2000, 480,000 Americans aged 55–64 had cognitive impairment at a level severe enough to be considered disabling.

Other research suggests that in 2004, Americans with young Alzheimer's and other dementias numbered from 220,000 to 640,000, according to an overview distributed at a conference on dementia sponsored by the Alzheimer's Association.

By the end of 2007, the Alzheimer's Association is expected to start using the term “young-onset” Alzheimer's because of the tendency of people to confuse “early-onset” with “early-stage” disease, said JoAnn Webster, early-onset coordinator for the Oklahoma and Arkansas chapters of the Alzheimer's Association in Tulsa.

“It's young people we're talking about, not early disease,” she said in an interview.

However, treatment, support, and education often are delayed because of lack of awareness of early-onset dementia and physician reluctance to diagnose Alzheimer's disease in younger patients.

Patients often are told they are depressed or have other mental disorders, and the dementia goes unrecognized, Ms. Webster said during a seminar. “The person with early-onset dementia may indeed have mild depression or depressed mood because of uncertainty and fear, and often they are given diagnoses of anxiety or panic disorder, or they're given an antidepressant and sent home,” she said.

When a woman begins to experience memory loss, she may be told by her physician that hormones are to blame and that her best option is to undergo a hysterectomy, she said.

When younger patients or their families complain of memory loss, physicians should launch the same battery of neurologic tests they would offer an elderly patient and, if dementia is diagnosed, they should immediately refer the patients to the Alzheimer's Association (800-272-3900) and its Web site (www.alz.org

“I push for a proper diagnosis, because knowing what's wrong gives them the power and strength to fight back, whereas dodging the real diagnosis is extremely stressful for them,” she added.

A proper diagnosis takes on additional importance when memory loss has led to job loss, Ms. Webster said, noting that having the diagnosis may confer eligibility for unemployment insurance.

“We've come to the point where we have to make a diagnosis for these people who are young, proactive, and want to know what's wrong with them. They need to understand that Alzheimer's is a treatable illness, and the more all of us learn about it, and the more people we can engage in treatment and clinical trials of new drugs, the sooner we'll find a cure,” Ms. Webster said.

She invited physicians to contact her by e-mail at joann.webster@alz.org

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CHICAGO — The increasing incidence of early-onset dementia represents both a national challenge and a future crisis, according to the Alzheimer's Association, which is about to change the designation to “young-onset.”

Data from the national Health and Retirement Study indicate that in 2000, 480,000 Americans aged 55–64 had cognitive impairment at a level severe enough to be considered disabling.

Other research suggests that in 2004, Americans with young Alzheimer's and other dementias numbered from 220,000 to 640,000, according to an overview distributed at a conference on dementia sponsored by the Alzheimer's Association.

By the end of 2007, the Alzheimer's Association is expected to start using the term “young-onset” Alzheimer's because of the tendency of people to confuse “early-onset” with “early-stage” disease, said JoAnn Webster, early-onset coordinator for the Oklahoma and Arkansas chapters of the Alzheimer's Association in Tulsa.

“It's young people we're talking about, not early disease,” she said in an interview.

However, treatment, support, and education often are delayed because of lack of awareness of early-onset dementia and physician reluctance to diagnose Alzheimer's disease in younger patients.

Patients often are told they are depressed or have other mental disorders, and the dementia goes unrecognized, Ms. Webster said during a seminar. “The person with early-onset dementia may indeed have mild depression or depressed mood because of uncertainty and fear, and often they are given diagnoses of anxiety or panic disorder, or they're given an antidepressant and sent home,” she said.

When a woman begins to experience memory loss, she may be told by her physician that hormones are to blame and that her best option is to undergo a hysterectomy, she said.

When younger patients or their families complain of memory loss, physicians should launch the same battery of neurologic tests they would offer an elderly patient and, if dementia is diagnosed, they should immediately refer the patients to the Alzheimer's Association (800-272-3900) and its Web site (www.alz.org

“I push for a proper diagnosis, because knowing what's wrong gives them the power and strength to fight back, whereas dodging the real diagnosis is extremely stressful for them,” she added.

A proper diagnosis takes on additional importance when memory loss has led to job loss, Ms. Webster said, noting that having the diagnosis may confer eligibility for unemployment insurance.

“We've come to the point where we have to make a diagnosis for these people who are young, proactive, and want to know what's wrong with them. They need to understand that Alzheimer's is a treatable illness, and the more all of us learn about it, and the more people we can engage in treatment and clinical trials of new drugs, the sooner we'll find a cure,” Ms. Webster said.

She invited physicians to contact her by e-mail at joann.webster@alz.org

CHICAGO — The increasing incidence of early-onset dementia represents both a national challenge and a future crisis, according to the Alzheimer's Association, which is about to change the designation to “young-onset.”

Data from the national Health and Retirement Study indicate that in 2000, 480,000 Americans aged 55–64 had cognitive impairment at a level severe enough to be considered disabling.

Other research suggests that in 2004, Americans with young Alzheimer's and other dementias numbered from 220,000 to 640,000, according to an overview distributed at a conference on dementia sponsored by the Alzheimer's Association.

By the end of 2007, the Alzheimer's Association is expected to start using the term “young-onset” Alzheimer's because of the tendency of people to confuse “early-onset” with “early-stage” disease, said JoAnn Webster, early-onset coordinator for the Oklahoma and Arkansas chapters of the Alzheimer's Association in Tulsa.

“It's young people we're talking about, not early disease,” she said in an interview.

However, treatment, support, and education often are delayed because of lack of awareness of early-onset dementia and physician reluctance to diagnose Alzheimer's disease in younger patients.

Patients often are told they are depressed or have other mental disorders, and the dementia goes unrecognized, Ms. Webster said during a seminar. “The person with early-onset dementia may indeed have mild depression or depressed mood because of uncertainty and fear, and often they are given diagnoses of anxiety or panic disorder, or they're given an antidepressant and sent home,” she said.

When a woman begins to experience memory loss, she may be told by her physician that hormones are to blame and that her best option is to undergo a hysterectomy, she said.

When younger patients or their families complain of memory loss, physicians should launch the same battery of neurologic tests they would offer an elderly patient and, if dementia is diagnosed, they should immediately refer the patients to the Alzheimer's Association (800-272-3900) and its Web site (www.alz.org

“I push for a proper diagnosis, because knowing what's wrong gives them the power and strength to fight back, whereas dodging the real diagnosis is extremely stressful for them,” she added.

A proper diagnosis takes on additional importance when memory loss has led to job loss, Ms. Webster said, noting that having the diagnosis may confer eligibility for unemployment insurance.

“We've come to the point where we have to make a diagnosis for these people who are young, proactive, and want to know what's wrong with them. They need to understand that Alzheimer's is a treatable illness, and the more all of us learn about it, and the more people we can engage in treatment and clinical trials of new drugs, the sooner we'll find a cure,” Ms. Webster said.

She invited physicians to contact her by e-mail at joann.webster@alz.org

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Two Doses of PCV7 Can't Do the Work of Three

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Two Doses of PCV7 Can't Do the Work of Three

CHICAGO — Trimming the seven-valent pneumococcal conjugate vaccine schedule from three prebooster doses to two may leave children more vulnerable to infection, according to data presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“Our study demonstrates that the reduced two-dose schedule at age 4 and 6 months cannot be regarded as equivalent to the licensed three-dose schedule at 2, 4, and 6 months,” said Dr. Ron Dagan, who presented the results of an ongoing, open-label randomized trial that was launched in 2005.

“The two-dose schedule resulted in significantly lower antibody concentrations to four vaccine serotypes compared with the three-dose licensed schedule, and the most impressive observed difference in immunogenicity was serotype 6B, which has cross-protection with 6A,” said Dr. Dagan of the pediatric infectious disease unit at Soroka University Medical Center, Ben-Gurion University, Beer-Sheva, Israel.

In its April 2007 meeting, the Immunization Strategic Advisory Group of Experts of the World Health Organization concluded that the number of doses required in primary vaccination schedules was not completely understood, though some evidence suggested that two doses in infancy were likely to be as good as three. They added that for pneumococcal conjugate vaccines, there may be differences in immunogenicity for some serotypes, Dr. Dagan explained.

“Despite the lack of knowledge, there is a tendency by some authorities to state that two and three doses of PCV7 in the primary immunization series—during the first year of life—are equivalent,” he said at the conference, which was sponsored by the American Society for Microbiology.

This study included healthy children aged 2 months, plus or minus 3 weeks, with parental informed consent. Exclusion criteria included prematurity (less than 35 weeks), acute disease, any chronic condition not permitting evaluation of the vaccine, prior administration of pneumococcal vaccine, known allergies related to vaccine constituents, and any contraindication to concomitant vaccines.

The children were randomized 2:1:1 to three groups:

Group 1: Licensed schedule of PCV7 at 2, 4, and 6 months.

Group 2: Reduced-dose schedule of PCV7 at 4 and 6 months.

Group 3: Unvaccinated (received the vaccine at 12 and 18 months).

Blood samples were refrigerated up to 8 hours until processed and serum was kept at −70° C until tested. Serum serotype-specific pneumococcal anticapsular IgG concentrations were tested by enzyme-linked immunosorbent assay after double absorption with C-polysaccharide and 22F-polysaccharide. Nasopharyngeal (NP) and oropharyngeal (OP) specimens were obtained by transport swabs and cultured within 16 hours, and OP results were reported only if Streptococcus pneumoniae was not isolated from the NP, Dr. Dagan said.

The postprimary serum analysis of geometric mean concentrations included 259 infants in the three-dose group and 133 infants in the two-dose group.

The three-dose group had four times more antibodies to serotype 6b (2.05 mcg/mL versus 0.55 mcg/mL) than was seen in the two-dose group. For serotype 14 the difference was 5.16 mcg/mL versus 3.54 mcg/mL; for 18C, 1.65 mcg/mL versus 1.23 mcg/mL and 23F levels were twice as high in the three-dose group at 1.08 mcg/mL versus 0.64 mcg/mL.

The Israeli scientists also found that a significantly higher proportion of three-dose subjects vs. two-dose subjects reached the cutoff serum anticapsular IgG concentration of 0.35 mcg/mL for serotypes 6B (87% versus 61%), 18C (96% versus 90%), and 23F (83% versus 70%).

In this analysis, they also used a cutoff of 1.0 mg/mL, which is favored by some physicians. Here again, the values were significantly higher in the three-dose group for 6B (71% versus 35%), 18C (75% versus 65%), and 23F (54% versus 33%).

The prevalence of 7-valent pneumococcal serotypes carriage remained unchanged for the first 6 months, but at 1 year, nearly one-third of the unimmunized children were carrying the serotypes, whereas about one-fifth of both vaccinated groups had carriage.

In the primary intervention schedules, there was a clear and significant reduction of new NP acquisition of both serotypes 6A and 6B in the three-dose cohort at 12 months, whereas no such reduction could be demonstrated in the two-dose group.

Serotype 6B was acquired by 9% of unvaccinated children, 7% of those who received two doses, and 4% of those in the three-dose group, with the P value reaching significance between the three-dose and no-vaccine groups. Serotype 6A was a different story, showing up in about 9% of both the unvaccinated and two-dose children, but only 4% of the three-dose group. More than 15% of unvaccinated children acquired either 6A or 6B.

“Serotype 6A acquisition is influenced by 6B antibody concentration, but you need more antibodies of anti-6B to influence 6A, so we speculated that 6A may be even more affected and this is exactly what happened,” Dr. Dagan said.

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CHICAGO — Trimming the seven-valent pneumococcal conjugate vaccine schedule from three prebooster doses to two may leave children more vulnerable to infection, according to data presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“Our study demonstrates that the reduced two-dose schedule at age 4 and 6 months cannot be regarded as equivalent to the licensed three-dose schedule at 2, 4, and 6 months,” said Dr. Ron Dagan, who presented the results of an ongoing, open-label randomized trial that was launched in 2005.

“The two-dose schedule resulted in significantly lower antibody concentrations to four vaccine serotypes compared with the three-dose licensed schedule, and the most impressive observed difference in immunogenicity was serotype 6B, which has cross-protection with 6A,” said Dr. Dagan of the pediatric infectious disease unit at Soroka University Medical Center, Ben-Gurion University, Beer-Sheva, Israel.

In its April 2007 meeting, the Immunization Strategic Advisory Group of Experts of the World Health Organization concluded that the number of doses required in primary vaccination schedules was not completely understood, though some evidence suggested that two doses in infancy were likely to be as good as three. They added that for pneumococcal conjugate vaccines, there may be differences in immunogenicity for some serotypes, Dr. Dagan explained.

“Despite the lack of knowledge, there is a tendency by some authorities to state that two and three doses of PCV7 in the primary immunization series—during the first year of life—are equivalent,” he said at the conference, which was sponsored by the American Society for Microbiology.

This study included healthy children aged 2 months, plus or minus 3 weeks, with parental informed consent. Exclusion criteria included prematurity (less than 35 weeks), acute disease, any chronic condition not permitting evaluation of the vaccine, prior administration of pneumococcal vaccine, known allergies related to vaccine constituents, and any contraindication to concomitant vaccines.

The children were randomized 2:1:1 to three groups:

Group 1: Licensed schedule of PCV7 at 2, 4, and 6 months.

Group 2: Reduced-dose schedule of PCV7 at 4 and 6 months.

Group 3: Unvaccinated (received the vaccine at 12 and 18 months).

Blood samples were refrigerated up to 8 hours until processed and serum was kept at −70° C until tested. Serum serotype-specific pneumococcal anticapsular IgG concentrations were tested by enzyme-linked immunosorbent assay after double absorption with C-polysaccharide and 22F-polysaccharide. Nasopharyngeal (NP) and oropharyngeal (OP) specimens were obtained by transport swabs and cultured within 16 hours, and OP results were reported only if Streptococcus pneumoniae was not isolated from the NP, Dr. Dagan said.

The postprimary serum analysis of geometric mean concentrations included 259 infants in the three-dose group and 133 infants in the two-dose group.

The three-dose group had four times more antibodies to serotype 6b (2.05 mcg/mL versus 0.55 mcg/mL) than was seen in the two-dose group. For serotype 14 the difference was 5.16 mcg/mL versus 3.54 mcg/mL; for 18C, 1.65 mcg/mL versus 1.23 mcg/mL and 23F levels were twice as high in the three-dose group at 1.08 mcg/mL versus 0.64 mcg/mL.

The Israeli scientists also found that a significantly higher proportion of three-dose subjects vs. two-dose subjects reached the cutoff serum anticapsular IgG concentration of 0.35 mcg/mL for serotypes 6B (87% versus 61%), 18C (96% versus 90%), and 23F (83% versus 70%).

In this analysis, they also used a cutoff of 1.0 mg/mL, which is favored by some physicians. Here again, the values were significantly higher in the three-dose group for 6B (71% versus 35%), 18C (75% versus 65%), and 23F (54% versus 33%).

The prevalence of 7-valent pneumococcal serotypes carriage remained unchanged for the first 6 months, but at 1 year, nearly one-third of the unimmunized children were carrying the serotypes, whereas about one-fifth of both vaccinated groups had carriage.

In the primary intervention schedules, there was a clear and significant reduction of new NP acquisition of both serotypes 6A and 6B in the three-dose cohort at 12 months, whereas no such reduction could be demonstrated in the two-dose group.

Serotype 6B was acquired by 9% of unvaccinated children, 7% of those who received two doses, and 4% of those in the three-dose group, with the P value reaching significance between the three-dose and no-vaccine groups. Serotype 6A was a different story, showing up in about 9% of both the unvaccinated and two-dose children, but only 4% of the three-dose group. More than 15% of unvaccinated children acquired either 6A or 6B.

“Serotype 6A acquisition is influenced by 6B antibody concentration, but you need more antibodies of anti-6B to influence 6A, so we speculated that 6A may be even more affected and this is exactly what happened,” Dr. Dagan said.

CHICAGO — Trimming the seven-valent pneumococcal conjugate vaccine schedule from three prebooster doses to two may leave children more vulnerable to infection, according to data presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“Our study demonstrates that the reduced two-dose schedule at age 4 and 6 months cannot be regarded as equivalent to the licensed three-dose schedule at 2, 4, and 6 months,” said Dr. Ron Dagan, who presented the results of an ongoing, open-label randomized trial that was launched in 2005.

“The two-dose schedule resulted in significantly lower antibody concentrations to four vaccine serotypes compared with the three-dose licensed schedule, and the most impressive observed difference in immunogenicity was serotype 6B, which has cross-protection with 6A,” said Dr. Dagan of the pediatric infectious disease unit at Soroka University Medical Center, Ben-Gurion University, Beer-Sheva, Israel.

In its April 2007 meeting, the Immunization Strategic Advisory Group of Experts of the World Health Organization concluded that the number of doses required in primary vaccination schedules was not completely understood, though some evidence suggested that two doses in infancy were likely to be as good as three. They added that for pneumococcal conjugate vaccines, there may be differences in immunogenicity for some serotypes, Dr. Dagan explained.

“Despite the lack of knowledge, there is a tendency by some authorities to state that two and three doses of PCV7 in the primary immunization series—during the first year of life—are equivalent,” he said at the conference, which was sponsored by the American Society for Microbiology.

This study included healthy children aged 2 months, plus or minus 3 weeks, with parental informed consent. Exclusion criteria included prematurity (less than 35 weeks), acute disease, any chronic condition not permitting evaluation of the vaccine, prior administration of pneumococcal vaccine, known allergies related to vaccine constituents, and any contraindication to concomitant vaccines.

The children were randomized 2:1:1 to three groups:

Group 1: Licensed schedule of PCV7 at 2, 4, and 6 months.

Group 2: Reduced-dose schedule of PCV7 at 4 and 6 months.

Group 3: Unvaccinated (received the vaccine at 12 and 18 months).

Blood samples were refrigerated up to 8 hours until processed and serum was kept at −70° C until tested. Serum serotype-specific pneumococcal anticapsular IgG concentrations were tested by enzyme-linked immunosorbent assay after double absorption with C-polysaccharide and 22F-polysaccharide. Nasopharyngeal (NP) and oropharyngeal (OP) specimens were obtained by transport swabs and cultured within 16 hours, and OP results were reported only if Streptococcus pneumoniae was not isolated from the NP, Dr. Dagan said.

The postprimary serum analysis of geometric mean concentrations included 259 infants in the three-dose group and 133 infants in the two-dose group.

The three-dose group had four times more antibodies to serotype 6b (2.05 mcg/mL versus 0.55 mcg/mL) than was seen in the two-dose group. For serotype 14 the difference was 5.16 mcg/mL versus 3.54 mcg/mL; for 18C, 1.65 mcg/mL versus 1.23 mcg/mL and 23F levels were twice as high in the three-dose group at 1.08 mcg/mL versus 0.64 mcg/mL.

The Israeli scientists also found that a significantly higher proportion of three-dose subjects vs. two-dose subjects reached the cutoff serum anticapsular IgG concentration of 0.35 mcg/mL for serotypes 6B (87% versus 61%), 18C (96% versus 90%), and 23F (83% versus 70%).

In this analysis, they also used a cutoff of 1.0 mg/mL, which is favored by some physicians. Here again, the values were significantly higher in the three-dose group for 6B (71% versus 35%), 18C (75% versus 65%), and 23F (54% versus 33%).

The prevalence of 7-valent pneumococcal serotypes carriage remained unchanged for the first 6 months, but at 1 year, nearly one-third of the unimmunized children were carrying the serotypes, whereas about one-fifth of both vaccinated groups had carriage.

In the primary intervention schedules, there was a clear and significant reduction of new NP acquisition of both serotypes 6A and 6B in the three-dose cohort at 12 months, whereas no such reduction could be demonstrated in the two-dose group.

Serotype 6B was acquired by 9% of unvaccinated children, 7% of those who received two doses, and 4% of those in the three-dose group, with the P value reaching significance between the three-dose and no-vaccine groups. Serotype 6A was a different story, showing up in about 9% of both the unvaccinated and two-dose children, but only 4% of the three-dose group. More than 15% of unvaccinated children acquired either 6A or 6B.

“Serotype 6A acquisition is influenced by 6B antibody concentration, but you need more antibodies of anti-6B to influence 6A, so we speculated that 6A may be even more affected and this is exactly what happened,” Dr. Dagan said.

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Two- and Three-Dose PCV7 Schedules Aren't Equivalent

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CHICAGO — Trimming the septivalent pneumococcal conjugate vaccine schedule from three prebooster doses to two may leave children more vulnerable to infection, according to data presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“Our study demonstrates that the reduced two-dose schedule at age 4 and 6 months cannot be regarded as equivalent to the licensed three-dose schedule at 2, 4, and 6 months,” said Dr. Ron Dagan, who presented the results of an ongoing, open-label randomized trial that was launched in 2005.

“The two-dose schedule resulted in significantly lower antibody concentrations to four vaccine serotypes compared with the three-dose licensed schedule, and the most impressive observed difference in immunogenicity was serotype 6B, which has cross-protection with 6A,” said Dr. Dagan of the pediatric infectious disease unit at Soroka University Medical Center, Ben-Gurion University, Beer-Sheva, Israel.

In its April 2007 meeting, the Immunization Strategic Advisory Group of Experts of the World Health Organization concluded that the number of doses required in primary vaccination schedules was not completely understood, though some evidence suggested that two doses in infancy were likely to be as good as three. They added that for pneumococcal conjugate vaccines, there may be differences in immunogenicity for some serotypes, Dr. Dagan explained.

“Despite the lack of knowledge, there is a tendency by some authorities to state that two and three doses of PCV7 in the primary immunization series—during the first year of life—are equivalent,” he said at the conference, which was sponsored by the American Society for Microbiology.

This study included healthy children aged 2 months, plus or minus 3 weeks, with parental informed consent. Exclusion criteria included prematurity (less than 35 weeks), acute disease, any chronic condition not permitting evaluation of the vaccine, prior administration of pneumococcal vaccine, known allergies related to vaccine constituents, and any contraindication to concomitant vaccines.

The children were randomized 2:1:1 to three groups:

▸ Group 1: Licensed schedule of PCV7 at 2, 4, and 6 months.

▸ Group 2: Reduced-dose schedule of PCV7 at 4 and 6 months.

▸ Group 3: Unvaccinated (received the vaccine at 12 and 18 months).

Blood samples were refrigerated up to 8 hours until processed and serum was kept at −70° C until tested. Serum serotype-specific pneumococcal anticapsular IgG concentrations were tested by enzyme-linked immunosorbent assay after double absorption with C-polysaccharide and 22F-polysaccharide. Nasopharyngeal (NP) and oropharyngeal (OP) specimens were obtained by transport swabs and cultured within 16 hours, and OP results were reported only if Streptococcus pneumoniae was not isolated from the NP, Dr. Dagan said.

The postprimary serum analysis of geometric mean concentrations included 259 infants in the three-dose group and 133 infants in the two-dose group.

The three-dose group had four times more antibodies to serotype 6b (2.05 mcg/mL versus 0.55 mcg/mL) than was seen in the two-dose group. For serotype 14 the difference was 5.16 mcg/mL versus 3.54 mcg/mL; for 18C, 1.65 mcg/mL versus 1.23 mcg/mL and 23F levels were twice as high in the three-dose group at 1.08 mcg/mL versus 0.64 mcg/mL.

The Israeli scientists also found that a significantly higher proportion of three-dose subjects vs. two-dose subjects reached the cutoff serum anticapsular IgG concentration of 0.35 mcg/mL for serotypes 6B (87% versus 61%), 18C (96% versus 90%), and 23F (83% versus 70%).

In this analysis, they also used a cutoff of 1.0 mg/mL, which is favored by some physicians. Here again, the values were significantly higher in the three-dose group for 6B (71% versus 35%), 18C (75% versus 65%), and 23F (54% versus 33%).

The prevalence of 7-valent pneumococcal serotypes carriage remained unchanged for the first 6 months, but at 1 year, nearly one-third of the unimmunized children were carrying the serotypes, whereas about one-fifth of both vaccinated groups had carriage.

In the primary intervention schedules, there was a clear and significant reduction of new NP acquisition of both serotypes 6A and 6B in the three-dose cohort at 12 months, whereas no such reduction could be demonstrated in the two-dose group.

Serotype 6B was acquired by 9% of unvaccinated children, 7% of those who received two doses, and 4% of those in the three-dose group, with the P value reaching significance between the three-dose and no-vaccine groups.

Serotype 6A was a different story, showing up in about 9% of both the unvaccinated and two-dose children, but only 4% of the three-dose group. More than 15% of unvaccinated children acquired either 6A or 6B.

“Serotype 6A acquisition is influenced by 6B antibody concentration, but you need more antibodies of anti-6B to influence 6A, so we speculated that 6A may be even more affected and this is exactly what happened,” Dr. Dagan said.

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CHICAGO — Trimming the septivalent pneumococcal conjugate vaccine schedule from three prebooster doses to two may leave children more vulnerable to infection, according to data presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“Our study demonstrates that the reduced two-dose schedule at age 4 and 6 months cannot be regarded as equivalent to the licensed three-dose schedule at 2, 4, and 6 months,” said Dr. Ron Dagan, who presented the results of an ongoing, open-label randomized trial that was launched in 2005.

“The two-dose schedule resulted in significantly lower antibody concentrations to four vaccine serotypes compared with the three-dose licensed schedule, and the most impressive observed difference in immunogenicity was serotype 6B, which has cross-protection with 6A,” said Dr. Dagan of the pediatric infectious disease unit at Soroka University Medical Center, Ben-Gurion University, Beer-Sheva, Israel.

In its April 2007 meeting, the Immunization Strategic Advisory Group of Experts of the World Health Organization concluded that the number of doses required in primary vaccination schedules was not completely understood, though some evidence suggested that two doses in infancy were likely to be as good as three. They added that for pneumococcal conjugate vaccines, there may be differences in immunogenicity for some serotypes, Dr. Dagan explained.

“Despite the lack of knowledge, there is a tendency by some authorities to state that two and three doses of PCV7 in the primary immunization series—during the first year of life—are equivalent,” he said at the conference, which was sponsored by the American Society for Microbiology.

This study included healthy children aged 2 months, plus or minus 3 weeks, with parental informed consent. Exclusion criteria included prematurity (less than 35 weeks), acute disease, any chronic condition not permitting evaluation of the vaccine, prior administration of pneumococcal vaccine, known allergies related to vaccine constituents, and any contraindication to concomitant vaccines.

The children were randomized 2:1:1 to three groups:

▸ Group 1: Licensed schedule of PCV7 at 2, 4, and 6 months.

▸ Group 2: Reduced-dose schedule of PCV7 at 4 and 6 months.

▸ Group 3: Unvaccinated (received the vaccine at 12 and 18 months).

Blood samples were refrigerated up to 8 hours until processed and serum was kept at −70° C until tested. Serum serotype-specific pneumococcal anticapsular IgG concentrations were tested by enzyme-linked immunosorbent assay after double absorption with C-polysaccharide and 22F-polysaccharide. Nasopharyngeal (NP) and oropharyngeal (OP) specimens were obtained by transport swabs and cultured within 16 hours, and OP results were reported only if Streptococcus pneumoniae was not isolated from the NP, Dr. Dagan said.

The postprimary serum analysis of geometric mean concentrations included 259 infants in the three-dose group and 133 infants in the two-dose group.

The three-dose group had four times more antibodies to serotype 6b (2.05 mcg/mL versus 0.55 mcg/mL) than was seen in the two-dose group. For serotype 14 the difference was 5.16 mcg/mL versus 3.54 mcg/mL; for 18C, 1.65 mcg/mL versus 1.23 mcg/mL and 23F levels were twice as high in the three-dose group at 1.08 mcg/mL versus 0.64 mcg/mL.

The Israeli scientists also found that a significantly higher proportion of three-dose subjects vs. two-dose subjects reached the cutoff serum anticapsular IgG concentration of 0.35 mcg/mL for serotypes 6B (87% versus 61%), 18C (96% versus 90%), and 23F (83% versus 70%).

In this analysis, they also used a cutoff of 1.0 mg/mL, which is favored by some physicians. Here again, the values were significantly higher in the three-dose group for 6B (71% versus 35%), 18C (75% versus 65%), and 23F (54% versus 33%).

The prevalence of 7-valent pneumococcal serotypes carriage remained unchanged for the first 6 months, but at 1 year, nearly one-third of the unimmunized children were carrying the serotypes, whereas about one-fifth of both vaccinated groups had carriage.

In the primary intervention schedules, there was a clear and significant reduction of new NP acquisition of both serotypes 6A and 6B in the three-dose cohort at 12 months, whereas no such reduction could be demonstrated in the two-dose group.

Serotype 6B was acquired by 9% of unvaccinated children, 7% of those who received two doses, and 4% of those in the three-dose group, with the P value reaching significance between the three-dose and no-vaccine groups.

Serotype 6A was a different story, showing up in about 9% of both the unvaccinated and two-dose children, but only 4% of the three-dose group. More than 15% of unvaccinated children acquired either 6A or 6B.

“Serotype 6A acquisition is influenced by 6B antibody concentration, but you need more antibodies of anti-6B to influence 6A, so we speculated that 6A may be even more affected and this is exactly what happened,” Dr. Dagan said.

CHICAGO — Trimming the septivalent pneumococcal conjugate vaccine schedule from three prebooster doses to two may leave children more vulnerable to infection, according to data presented at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

“Our study demonstrates that the reduced two-dose schedule at age 4 and 6 months cannot be regarded as equivalent to the licensed three-dose schedule at 2, 4, and 6 months,” said Dr. Ron Dagan, who presented the results of an ongoing, open-label randomized trial that was launched in 2005.

“The two-dose schedule resulted in significantly lower antibody concentrations to four vaccine serotypes compared with the three-dose licensed schedule, and the most impressive observed difference in immunogenicity was serotype 6B, which has cross-protection with 6A,” said Dr. Dagan of the pediatric infectious disease unit at Soroka University Medical Center, Ben-Gurion University, Beer-Sheva, Israel.

In its April 2007 meeting, the Immunization Strategic Advisory Group of Experts of the World Health Organization concluded that the number of doses required in primary vaccination schedules was not completely understood, though some evidence suggested that two doses in infancy were likely to be as good as three. They added that for pneumococcal conjugate vaccines, there may be differences in immunogenicity for some serotypes, Dr. Dagan explained.

“Despite the lack of knowledge, there is a tendency by some authorities to state that two and three doses of PCV7 in the primary immunization series—during the first year of life—are equivalent,” he said at the conference, which was sponsored by the American Society for Microbiology.

This study included healthy children aged 2 months, plus or minus 3 weeks, with parental informed consent. Exclusion criteria included prematurity (less than 35 weeks), acute disease, any chronic condition not permitting evaluation of the vaccine, prior administration of pneumococcal vaccine, known allergies related to vaccine constituents, and any contraindication to concomitant vaccines.

The children were randomized 2:1:1 to three groups:

▸ Group 1: Licensed schedule of PCV7 at 2, 4, and 6 months.

▸ Group 2: Reduced-dose schedule of PCV7 at 4 and 6 months.

▸ Group 3: Unvaccinated (received the vaccine at 12 and 18 months).

Blood samples were refrigerated up to 8 hours until processed and serum was kept at −70° C until tested. Serum serotype-specific pneumococcal anticapsular IgG concentrations were tested by enzyme-linked immunosorbent assay after double absorption with C-polysaccharide and 22F-polysaccharide. Nasopharyngeal (NP) and oropharyngeal (OP) specimens were obtained by transport swabs and cultured within 16 hours, and OP results were reported only if Streptococcus pneumoniae was not isolated from the NP, Dr. Dagan said.

The postprimary serum analysis of geometric mean concentrations included 259 infants in the three-dose group and 133 infants in the two-dose group.

The three-dose group had four times more antibodies to serotype 6b (2.05 mcg/mL versus 0.55 mcg/mL) than was seen in the two-dose group. For serotype 14 the difference was 5.16 mcg/mL versus 3.54 mcg/mL; for 18C, 1.65 mcg/mL versus 1.23 mcg/mL and 23F levels were twice as high in the three-dose group at 1.08 mcg/mL versus 0.64 mcg/mL.

The Israeli scientists also found that a significantly higher proportion of three-dose subjects vs. two-dose subjects reached the cutoff serum anticapsular IgG concentration of 0.35 mcg/mL for serotypes 6B (87% versus 61%), 18C (96% versus 90%), and 23F (83% versus 70%).

In this analysis, they also used a cutoff of 1.0 mg/mL, which is favored by some physicians. Here again, the values were significantly higher in the three-dose group for 6B (71% versus 35%), 18C (75% versus 65%), and 23F (54% versus 33%).

The prevalence of 7-valent pneumococcal serotypes carriage remained unchanged for the first 6 months, but at 1 year, nearly one-third of the unimmunized children were carrying the serotypes, whereas about one-fifth of both vaccinated groups had carriage.

In the primary intervention schedules, there was a clear and significant reduction of new NP acquisition of both serotypes 6A and 6B in the three-dose cohort at 12 months, whereas no such reduction could be demonstrated in the two-dose group.

Serotype 6B was acquired by 9% of unvaccinated children, 7% of those who received two doses, and 4% of those in the three-dose group, with the P value reaching significance between the three-dose and no-vaccine groups.

Serotype 6A was a different story, showing up in about 9% of both the unvaccinated and two-dose children, but only 4% of the three-dose group. More than 15% of unvaccinated children acquired either 6A or 6B.

“Serotype 6A acquisition is influenced by 6B antibody concentration, but you need more antibodies of anti-6B to influence 6A, so we speculated that 6A may be even more affected and this is exactly what happened,” Dr. Dagan said.

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Anti-MRSA Program Succeeds Across Institutions : 'A coordinated hand-hygiene program [can] bring significant reductions in MRSA infection rates.'

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Anti-MRSA Program Succeeds Across Institutions : 'A coordinated hand-hygiene program [can] bring significant reductions in MRSA infection rates.'

CHICAGO — Multisite implementation of a generic hand-hygiene culture-change program can significantly reduce infections caused by methicillin-resistant Staphylococcus aureus, according to Dr. M. Lindsay Grayson.

In a landmark study involving six urban and rural Australian hospitals, a centrally organized program encouraging the widespread use of alcohol-based hand rubs halved MRSA bacteremia rates, Dr. Grayson said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

It is the first large multisite study to demonstrate the benefits of a hand-hygiene culture change, said Dr. Grayson, director of infectious diseases at Austin Health, a provider of tertiary health services in Melbourne, and professorial fellow at the University of Melbourne. In fact, it was a single-institution study at Austin Hospital that set the stage for this expanded study (Med. J. Aust. 2005;183:509–14).

“[In the current study, we] introduced alcohol-based hand rubs and alcohol wipes for [those sharing] equipment, as well as an educational program for health care workers, patients, and patients' relatives,” he reported.

The researchers encouraged the culture change with a promotional drive that included coffee-break seminars, quizzes with prizes, a newsletter on hand hygiene, and the attachment of notices to staffers' pay advice slips. They devised slogans to remind people about hand hygiene, and even hired an advertising consultant to maximize the effect of the message.

They also held feedback sessions with senior nurses on sentinel wards to provide them with information on recent outcome data, and they conducted medical, surgical, and nursing grand rounds on MRSA.

A key component of the program was the development of a computer-based educational package that could be accessed online.

These and other culture change procedures were maintained and used in the 2-year multicenter study of four hospitals in metropolitan Melbourne and two regional hospitals. The program was coordinated by staff at Austin Health and the Victorian Quality Council in Melbourne, and funding was provided by the Department of Human Services for the state of Victoria, which backs efforts to control the MRSA “superbug.”

The primary outcome measures were rates of hand-hygiene compliance measured at 3- and 6-month intervals, and of MRSA disease—including bacteremia and clinical isolates—per 100 patient discharges measured at 1-month intervals, Dr. Grayson said.

“For all six sites, hand-hygiene compliance rose from 21% at baseline to 47% at 2 years. We identified the same significant improvements in MRSA disease rates that we identified in the single-center Austin study,” he said, noting that MRSA bacteremia fell from 0.03 to 0.01 per 100 patient discharges, and clinical isolates fell from 1.12 to 0.8 per 100 discharges.

“We were able to show that during the 2-year program, there were 719 fewer isolates than would have been expected had we not intervened. More importantly, MRSA bacteremia rates were roughly halved, with 60 fewer patients developing bacteremia than we would have otherwise expected,” Dr. Grayson said at the meeting, which was sponsored by the American Society for Microbiology.

The results of a cost analysis suggest that the culture change produced a potential savings over the 2-year period of at least $1.5 million. “The program cost roughly $750,000, so this was a 2-to-1 multiplier effect in terms of savings,” Dr. Grayson said.

This study shows that “a coordinated hand-hygiene program that does not involve direct observation can improve compliance in both rural and urban health care settings and bring significant reductions in MRSA infection rates,” he concluded.

A Swiss researcher, Dr. Hugo Sax, said that although such studies show that progress is being made in hand hygiene, optimal rates of compliance will be achieved only if more physicians lead by example.

“We have to address and educate different health care populations with tailored approaches instead of a one-size-fits-all approach,” said Dr. Sax, a consulting physician at the University Hospital in Geneva.

But first, physicians must align their own thinking toward patient safety, he said in an interview. “Physician training doesn't have the same patient-care focus that nurses and others experience, so hygiene is not a high-level issue for physicians, and it should be.”

Dr. John M. Boyce, chief of infectious diseases at the Hospital of Saint Raphael in New Haven, Conn., agreed. “The evidence that hand hygiene reduces the spread of MRSA and other organisms is compelling, and we have to convince our physician colleagues that using alcohol hand rubs both before and after each patient visit doesn't slow down their daily routines,” he said in an interview.

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CHICAGO — Multisite implementation of a generic hand-hygiene culture-change program can significantly reduce infections caused by methicillin-resistant Staphylococcus aureus, according to Dr. M. Lindsay Grayson.

In a landmark study involving six urban and rural Australian hospitals, a centrally organized program encouraging the widespread use of alcohol-based hand rubs halved MRSA bacteremia rates, Dr. Grayson said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

It is the first large multisite study to demonstrate the benefits of a hand-hygiene culture change, said Dr. Grayson, director of infectious diseases at Austin Health, a provider of tertiary health services in Melbourne, and professorial fellow at the University of Melbourne. In fact, it was a single-institution study at Austin Hospital that set the stage for this expanded study (Med. J. Aust. 2005;183:509–14).

“[In the current study, we] introduced alcohol-based hand rubs and alcohol wipes for [those sharing] equipment, as well as an educational program for health care workers, patients, and patients' relatives,” he reported.

The researchers encouraged the culture change with a promotional drive that included coffee-break seminars, quizzes with prizes, a newsletter on hand hygiene, and the attachment of notices to staffers' pay advice slips. They devised slogans to remind people about hand hygiene, and even hired an advertising consultant to maximize the effect of the message.

They also held feedback sessions with senior nurses on sentinel wards to provide them with information on recent outcome data, and they conducted medical, surgical, and nursing grand rounds on MRSA.

A key component of the program was the development of a computer-based educational package that could be accessed online.

These and other culture change procedures were maintained and used in the 2-year multicenter study of four hospitals in metropolitan Melbourne and two regional hospitals. The program was coordinated by staff at Austin Health and the Victorian Quality Council in Melbourne, and funding was provided by the Department of Human Services for the state of Victoria, which backs efforts to control the MRSA “superbug.”

The primary outcome measures were rates of hand-hygiene compliance measured at 3- and 6-month intervals, and of MRSA disease—including bacteremia and clinical isolates—per 100 patient discharges measured at 1-month intervals, Dr. Grayson said.

“For all six sites, hand-hygiene compliance rose from 21% at baseline to 47% at 2 years. We identified the same significant improvements in MRSA disease rates that we identified in the single-center Austin study,” he said, noting that MRSA bacteremia fell from 0.03 to 0.01 per 100 patient discharges, and clinical isolates fell from 1.12 to 0.8 per 100 discharges.

“We were able to show that during the 2-year program, there were 719 fewer isolates than would have been expected had we not intervened. More importantly, MRSA bacteremia rates were roughly halved, with 60 fewer patients developing bacteremia than we would have otherwise expected,” Dr. Grayson said at the meeting, which was sponsored by the American Society for Microbiology.

The results of a cost analysis suggest that the culture change produced a potential savings over the 2-year period of at least $1.5 million. “The program cost roughly $750,000, so this was a 2-to-1 multiplier effect in terms of savings,” Dr. Grayson said.

This study shows that “a coordinated hand-hygiene program that does not involve direct observation can improve compliance in both rural and urban health care settings and bring significant reductions in MRSA infection rates,” he concluded.

A Swiss researcher, Dr. Hugo Sax, said that although such studies show that progress is being made in hand hygiene, optimal rates of compliance will be achieved only if more physicians lead by example.

“We have to address and educate different health care populations with tailored approaches instead of a one-size-fits-all approach,” said Dr. Sax, a consulting physician at the University Hospital in Geneva.

But first, physicians must align their own thinking toward patient safety, he said in an interview. “Physician training doesn't have the same patient-care focus that nurses and others experience, so hygiene is not a high-level issue for physicians, and it should be.”

Dr. John M. Boyce, chief of infectious diseases at the Hospital of Saint Raphael in New Haven, Conn., agreed. “The evidence that hand hygiene reduces the spread of MRSA and other organisms is compelling, and we have to convince our physician colleagues that using alcohol hand rubs both before and after each patient visit doesn't slow down their daily routines,” he said in an interview.

CHICAGO — Multisite implementation of a generic hand-hygiene culture-change program can significantly reduce infections caused by methicillin-resistant Staphylococcus aureus, according to Dr. M. Lindsay Grayson.

In a landmark study involving six urban and rural Australian hospitals, a centrally organized program encouraging the widespread use of alcohol-based hand rubs halved MRSA bacteremia rates, Dr. Grayson said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

It is the first large multisite study to demonstrate the benefits of a hand-hygiene culture change, said Dr. Grayson, director of infectious diseases at Austin Health, a provider of tertiary health services in Melbourne, and professorial fellow at the University of Melbourne. In fact, it was a single-institution study at Austin Hospital that set the stage for this expanded study (Med. J. Aust. 2005;183:509–14).

“[In the current study, we] introduced alcohol-based hand rubs and alcohol wipes for [those sharing] equipment, as well as an educational program for health care workers, patients, and patients' relatives,” he reported.

The researchers encouraged the culture change with a promotional drive that included coffee-break seminars, quizzes with prizes, a newsletter on hand hygiene, and the attachment of notices to staffers' pay advice slips. They devised slogans to remind people about hand hygiene, and even hired an advertising consultant to maximize the effect of the message.

They also held feedback sessions with senior nurses on sentinel wards to provide them with information on recent outcome data, and they conducted medical, surgical, and nursing grand rounds on MRSA.

A key component of the program was the development of a computer-based educational package that could be accessed online.

These and other culture change procedures were maintained and used in the 2-year multicenter study of four hospitals in metropolitan Melbourne and two regional hospitals. The program was coordinated by staff at Austin Health and the Victorian Quality Council in Melbourne, and funding was provided by the Department of Human Services for the state of Victoria, which backs efforts to control the MRSA “superbug.”

The primary outcome measures were rates of hand-hygiene compliance measured at 3- and 6-month intervals, and of MRSA disease—including bacteremia and clinical isolates—per 100 patient discharges measured at 1-month intervals, Dr. Grayson said.

“For all six sites, hand-hygiene compliance rose from 21% at baseline to 47% at 2 years. We identified the same significant improvements in MRSA disease rates that we identified in the single-center Austin study,” he said, noting that MRSA bacteremia fell from 0.03 to 0.01 per 100 patient discharges, and clinical isolates fell from 1.12 to 0.8 per 100 discharges.

“We were able to show that during the 2-year program, there were 719 fewer isolates than would have been expected had we not intervened. More importantly, MRSA bacteremia rates were roughly halved, with 60 fewer patients developing bacteremia than we would have otherwise expected,” Dr. Grayson said at the meeting, which was sponsored by the American Society for Microbiology.

The results of a cost analysis suggest that the culture change produced a potential savings over the 2-year period of at least $1.5 million. “The program cost roughly $750,000, so this was a 2-to-1 multiplier effect in terms of savings,” Dr. Grayson said.

This study shows that “a coordinated hand-hygiene program that does not involve direct observation can improve compliance in both rural and urban health care settings and bring significant reductions in MRSA infection rates,” he concluded.

A Swiss researcher, Dr. Hugo Sax, said that although such studies show that progress is being made in hand hygiene, optimal rates of compliance will be achieved only if more physicians lead by example.

“We have to address and educate different health care populations with tailored approaches instead of a one-size-fits-all approach,” said Dr. Sax, a consulting physician at the University Hospital in Geneva.

But first, physicians must align their own thinking toward patient safety, he said in an interview. “Physician training doesn't have the same patient-care focus that nurses and others experience, so hygiene is not a high-level issue for physicians, and it should be.”

Dr. John M. Boyce, chief of infectious diseases at the Hospital of Saint Raphael in New Haven, Conn., agreed. “The evidence that hand hygiene reduces the spread of MRSA and other organisms is compelling, and we have to convince our physician colleagues that using alcohol hand rubs both before and after each patient visit doesn't slow down their daily routines,” he said in an interview.

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Gardasil 96% Effective Against Premalignancies

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Gardasil 96% Effective Against Premalignancies

CHICAGO — The quadrivalent human papillomavirus vaccine, which protects women against HPV types 6, 11, 16, and 18, also prevents the abnormal growth of precancerous cells in the cervix associated with these four types.

This finding, from the international phase IIb/III Quadrivalent HPV Vaccine Study, was reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

These premalignancies, known as cervical intraepithelial neoplasia (CIN), are a major contributor to health care costs resulting from screening, research, and treatment, Dr. Sven-Eric Olsson said at the conference, which was sponsored by the American Society for Microbiology.

Through 3 years of follow-up, the vaccine was 96% effective in preventing CIN related to HPV types 6, 11, 16, and 18, and vaccine efficacy was significant for all four of the HPV types, though somewhat less so for HPV 11, said Dr. Olsson, with the Karolinska Institute at Danderyds Hospital in Stockholm.

The Food and Drug Administration-approved quadrivalent HPV vaccine (Gardasil; Merck & Co.) is recommended by the Centers for Disease Control and Prevention for use by women aged 9-26 years. The four targeted HPV types are responsible for 70% of cervical cancers and 90% of genital warts, according to the CDC.

The investigators drew data from more than 18,000 women aged 16-26 years who were enrolled in one of three randomized trials sponsored by Merck.

The cohort of women was evenly divided to receive either vaccine or placebo at day 1, month 2, and month 6. Subjects underwent cervicovaginal sampling at day 1 and month 7 and Pap testing at day 1 and 6- to 12-month intervals for up to 48 months.

All of the specimens were HPV typed and histologically diagnosed by a four-member blinded pathology panel, said Dr. Olsson. He has given lectures for Merck but has no financial stake in either Merck or GlaxoSmithKline, which has filed with the FDA for approval of Cervarix, a bivalent HPV vaccine protecting against types 16 and 18.

Primary per protocol vaccine efficacy analysis included subjects who received all three of the doses, were sero- and PCR-negative to the four HPV types at day 1 and PCR-negative through month 7, and had no major protocol deviations.

Dr. Olsson reported that in the group that received the vaccine, there were 6 cases of HPV 6/11/16/18 CIN, compared with 148 cases in the placebo group, providing the vaccine efficacy of 96%.

"And for CIN [grade] 2 or worse, including adenocarcinoma in situ, there was 1 case in the vaccine group and 76 cases in the placebo arm, for a 99% efficacy rate," he said, adding that vaccine efficacy against HPV 6/11/16/18-related CIN ranged from 95.5% to 100% based on CIN grade. (Grade 1 is low-grade squamous intraepithelial lesion; grades 2 and 3 are high-grade squamous intraepithelial lesions.)

The single case of CIN 3 in the vaccinated group (there were 46 in the placebo arm) was a Brazilian woman who was positive for HPV 52 at day 1 and at 32 months was shown to be positive for both 52 and 16. She subsequently underwent a loop electrosurgical excision procedure.

"The lifetime risk of acquiring an HPV infection for sexually active people is 50%, and approaches 75% in some settings," Dr. Olsson explained, adding that HPV causes cervical cancer in 3%-4% of unscreened women. "When we do the screening, we reduce the frequency of cervical cancer, but in doing so we create a new disease … CIN."

A separate analysis of data from this same cohort of women suggests that in these women, aged 16-26 years, Gardasil vaccination reduces the overall incidence of Pap abnormalities regardless of the HPV types involved.

In a poster presentation, the researchers analyzed the impact on rates of abnormal Pap tests in women who, at day 1 of the study, had a negative Pap test and were DNA negative to 14 common HPV types and seronegative to the four vaccine HPV types discussed above.

In this generally HPV-naïve population, Gardasil prevented almost half of high-grade squamous intraepithelial lesions, compared with placebo. "Given these results, the impact on HPV 6/11/16/18-related Pap abnormalities is expected to be dramatic," the authors wrote.

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CHICAGO — The quadrivalent human papillomavirus vaccine, which protects women against HPV types 6, 11, 16, and 18, also prevents the abnormal growth of precancerous cells in the cervix associated with these four types.

This finding, from the international phase IIb/III Quadrivalent HPV Vaccine Study, was reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

These premalignancies, known as cervical intraepithelial neoplasia (CIN), are a major contributor to health care costs resulting from screening, research, and treatment, Dr. Sven-Eric Olsson said at the conference, which was sponsored by the American Society for Microbiology.

Through 3 years of follow-up, the vaccine was 96% effective in preventing CIN related to HPV types 6, 11, 16, and 18, and vaccine efficacy was significant for all four of the HPV types, though somewhat less so for HPV 11, said Dr. Olsson, with the Karolinska Institute at Danderyds Hospital in Stockholm.

The Food and Drug Administration-approved quadrivalent HPV vaccine (Gardasil; Merck & Co.) is recommended by the Centers for Disease Control and Prevention for use by women aged 9-26 years. The four targeted HPV types are responsible for 70% of cervical cancers and 90% of genital warts, according to the CDC.

The investigators drew data from more than 18,000 women aged 16-26 years who were enrolled in one of three randomized trials sponsored by Merck.

The cohort of women was evenly divided to receive either vaccine or placebo at day 1, month 2, and month 6. Subjects underwent cervicovaginal sampling at day 1 and month 7 and Pap testing at day 1 and 6- to 12-month intervals for up to 48 months.

All of the specimens were HPV typed and histologically diagnosed by a four-member blinded pathology panel, said Dr. Olsson. He has given lectures for Merck but has no financial stake in either Merck or GlaxoSmithKline, which has filed with the FDA for approval of Cervarix, a bivalent HPV vaccine protecting against types 16 and 18.

Primary per protocol vaccine efficacy analysis included subjects who received all three of the doses, were sero- and PCR-negative to the four HPV types at day 1 and PCR-negative through month 7, and had no major protocol deviations.

Dr. Olsson reported that in the group that received the vaccine, there were 6 cases of HPV 6/11/16/18 CIN, compared with 148 cases in the placebo group, providing the vaccine efficacy of 96%.

"And for CIN [grade] 2 or worse, including adenocarcinoma in situ, there was 1 case in the vaccine group and 76 cases in the placebo arm, for a 99% efficacy rate," he said, adding that vaccine efficacy against HPV 6/11/16/18-related CIN ranged from 95.5% to 100% based on CIN grade. (Grade 1 is low-grade squamous intraepithelial lesion; grades 2 and 3 are high-grade squamous intraepithelial lesions.)

The single case of CIN 3 in the vaccinated group (there were 46 in the placebo arm) was a Brazilian woman who was positive for HPV 52 at day 1 and at 32 months was shown to be positive for both 52 and 16. She subsequently underwent a loop electrosurgical excision procedure.

"The lifetime risk of acquiring an HPV infection for sexually active people is 50%, and approaches 75% in some settings," Dr. Olsson explained, adding that HPV causes cervical cancer in 3%-4% of unscreened women. "When we do the screening, we reduce the frequency of cervical cancer, but in doing so we create a new disease … CIN."

A separate analysis of data from this same cohort of women suggests that in these women, aged 16-26 years, Gardasil vaccination reduces the overall incidence of Pap abnormalities regardless of the HPV types involved.

In a poster presentation, the researchers analyzed the impact on rates of abnormal Pap tests in women who, at day 1 of the study, had a negative Pap test and were DNA negative to 14 common HPV types and seronegative to the four vaccine HPV types discussed above.

In this generally HPV-naïve population, Gardasil prevented almost half of high-grade squamous intraepithelial lesions, compared with placebo. "Given these results, the impact on HPV 6/11/16/18-related Pap abnormalities is expected to be dramatic," the authors wrote.

CHICAGO — The quadrivalent human papillomavirus vaccine, which protects women against HPV types 6, 11, 16, and 18, also prevents the abnormal growth of precancerous cells in the cervix associated with these four types.

This finding, from the international phase IIb/III Quadrivalent HPV Vaccine Study, was reported at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.

These premalignancies, known as cervical intraepithelial neoplasia (CIN), are a major contributor to health care costs resulting from screening, research, and treatment, Dr. Sven-Eric Olsson said at the conference, which was sponsored by the American Society for Microbiology.

Through 3 years of follow-up, the vaccine was 96% effective in preventing CIN related to HPV types 6, 11, 16, and 18, and vaccine efficacy was significant for all four of the HPV types, though somewhat less so for HPV 11, said Dr. Olsson, with the Karolinska Institute at Danderyds Hospital in Stockholm.

The Food and Drug Administration-approved quadrivalent HPV vaccine (Gardasil; Merck & Co.) is recommended by the Centers for Disease Control and Prevention for use by women aged 9-26 years. The four targeted HPV types are responsible for 70% of cervical cancers and 90% of genital warts, according to the CDC.

The investigators drew data from more than 18,000 women aged 16-26 years who were enrolled in one of three randomized trials sponsored by Merck.

The cohort of women was evenly divided to receive either vaccine or placebo at day 1, month 2, and month 6. Subjects underwent cervicovaginal sampling at day 1 and month 7 and Pap testing at day 1 and 6- to 12-month intervals for up to 48 months.

All of the specimens were HPV typed and histologically diagnosed by a four-member blinded pathology panel, said Dr. Olsson. He has given lectures for Merck but has no financial stake in either Merck or GlaxoSmithKline, which has filed with the FDA for approval of Cervarix, a bivalent HPV vaccine protecting against types 16 and 18.

Primary per protocol vaccine efficacy analysis included subjects who received all three of the doses, were sero- and PCR-negative to the four HPV types at day 1 and PCR-negative through month 7, and had no major protocol deviations.

Dr. Olsson reported that in the group that received the vaccine, there were 6 cases of HPV 6/11/16/18 CIN, compared with 148 cases in the placebo group, providing the vaccine efficacy of 96%.

"And for CIN [grade] 2 or worse, including adenocarcinoma in situ, there was 1 case in the vaccine group and 76 cases in the placebo arm, for a 99% efficacy rate," he said, adding that vaccine efficacy against HPV 6/11/16/18-related CIN ranged from 95.5% to 100% based on CIN grade. (Grade 1 is low-grade squamous intraepithelial lesion; grades 2 and 3 are high-grade squamous intraepithelial lesions.)

The single case of CIN 3 in the vaccinated group (there were 46 in the placebo arm) was a Brazilian woman who was positive for HPV 52 at day 1 and at 32 months was shown to be positive for both 52 and 16. She subsequently underwent a loop electrosurgical excision procedure.

"The lifetime risk of acquiring an HPV infection for sexually active people is 50%, and approaches 75% in some settings," Dr. Olsson explained, adding that HPV causes cervical cancer in 3%-4% of unscreened women. "When we do the screening, we reduce the frequency of cervical cancer, but in doing so we create a new disease … CIN."

A separate analysis of data from this same cohort of women suggests that in these women, aged 16-26 years, Gardasil vaccination reduces the overall incidence of Pap abnormalities regardless of the HPV types involved.

In a poster presentation, the researchers analyzed the impact on rates of abnormal Pap tests in women who, at day 1 of the study, had a negative Pap test and were DNA negative to 14 common HPV types and seronegative to the four vaccine HPV types discussed above.

In this generally HPV-naïve population, Gardasil prevented almost half of high-grade squamous intraepithelial lesions, compared with placebo. "Given these results, the impact on HPV 6/11/16/18-related Pap abnormalities is expected to be dramatic," the authors wrote.

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Pulsed-Light Device Allows for Home Hair Removal

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CHICAGO — A new low-energy, pulsed-light device promises a safe way for women to do their own long-term hair removal at home for the first time, according to Dr. Tina Alster.

The handheld device was tested for safety and efficacy by 20 women aged 32-56 years, with Fitzpatrick skin types 1 through 5 and brown or black terminal hair, Dr. Alster said at the annual meeting of the American Society for Dermatologic Surgery.

The device manufacturer recently submitted the product for 510(k) clearance from the Food and Drug Administration, but a decision is not expected before the end of the year, according to company spokesman Tom Goslau. The Silk'n hair removal device (HomeSkinovations Ltd., Tel Aviv) emits wavelengths of 475-1,200 nm and fluences up to 5 J/mm2.

Hair removal is the top skin treatment worldwide, with total annual sales approaching $9 billion, said Dr. Alster, who is medical director of the Washington (D.C.) Institute of Dermatologic Laser Surgery.

"The low end of the market—shaving and waxing—constitutes $5.7 billion of the total, with the remaining $3 billion coming from high-end procedures such as laser and light treatment," she said, adding that only 2% of the population can afford professional treatment.

Of the 20 women, 7 treated themselves under the axillary region, 3 on the forearm, 5 in the inguinal region, and 5 on the lower legs. "All women self-administered three or four light treatments at 2-week intervals in our office so that we could make sure they weren't using the device more often than necessary," Dr. Alster said.

"We saw hair reductions ranging from 40% to 75%, with the legs and arms responding slightly better than the underarm and bikini region," she said in an interview, adding that the return of hair was slightly higher on the legs, though lower-leg hair reduction averaged 61% at 3-month follow-up. And unlike some earlier experimental devices, the Silk'n caused no complications or pain.

Respectively, the 1- and 3-month hair removal results were axillae, 48% and 42%; arms, 59% and 58%; inguinal area, 48% and 40%; and legs, 73.5% and 61%.

"This pulsed-light unit is portable, lightweight, has an internal cooling fan, uses regular household current, provides a light pulse every 3.5 seconds, and is self-contained, making protective eyewear unnecessary," explained Dr. Alster, who has conducted research for Zars Pharma and Galderma.

The equipment used in this study was provided by HomeSkinovations.

If clearance is received, the Silk'n will go on the market at a price of between $250 and $500, she said. "My guess is that many of those who have been getting hair removal treatments at spas will purchase these devices and do this in the privacy of their homes."

Home hair removal equipment will not have much financial effect on dermatology, Dr. Alster predicted. "We're not getting 98% of people anyway, and I think [home treatment] is an idea whose time has come, and I think it's going to take off. Buying this device will cost less than a single treatment in my office."

A patient's underarm area is shown above before hair removal treatment.

The same underarm is shown 1 month after self-administration of the device.

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CHICAGO — A new low-energy, pulsed-light device promises a safe way for women to do their own long-term hair removal at home for the first time, according to Dr. Tina Alster.

The handheld device was tested for safety and efficacy by 20 women aged 32-56 years, with Fitzpatrick skin types 1 through 5 and brown or black terminal hair, Dr. Alster said at the annual meeting of the American Society for Dermatologic Surgery.

The device manufacturer recently submitted the product for 510(k) clearance from the Food and Drug Administration, but a decision is not expected before the end of the year, according to company spokesman Tom Goslau. The Silk'n hair removal device (HomeSkinovations Ltd., Tel Aviv) emits wavelengths of 475-1,200 nm and fluences up to 5 J/mm2.

Hair removal is the top skin treatment worldwide, with total annual sales approaching $9 billion, said Dr. Alster, who is medical director of the Washington (D.C.) Institute of Dermatologic Laser Surgery.

"The low end of the market—shaving and waxing—constitutes $5.7 billion of the total, with the remaining $3 billion coming from high-end procedures such as laser and light treatment," she said, adding that only 2% of the population can afford professional treatment.

Of the 20 women, 7 treated themselves under the axillary region, 3 on the forearm, 5 in the inguinal region, and 5 on the lower legs. "All women self-administered three or four light treatments at 2-week intervals in our office so that we could make sure they weren't using the device more often than necessary," Dr. Alster said.

"We saw hair reductions ranging from 40% to 75%, with the legs and arms responding slightly better than the underarm and bikini region," she said in an interview, adding that the return of hair was slightly higher on the legs, though lower-leg hair reduction averaged 61% at 3-month follow-up. And unlike some earlier experimental devices, the Silk'n caused no complications or pain.

Respectively, the 1- and 3-month hair removal results were axillae, 48% and 42%; arms, 59% and 58%; inguinal area, 48% and 40%; and legs, 73.5% and 61%.

"This pulsed-light unit is portable, lightweight, has an internal cooling fan, uses regular household current, provides a light pulse every 3.5 seconds, and is self-contained, making protective eyewear unnecessary," explained Dr. Alster, who has conducted research for Zars Pharma and Galderma.

The equipment used in this study was provided by HomeSkinovations.

If clearance is received, the Silk'n will go on the market at a price of between $250 and $500, she said. "My guess is that many of those who have been getting hair removal treatments at spas will purchase these devices and do this in the privacy of their homes."

Home hair removal equipment will not have much financial effect on dermatology, Dr. Alster predicted. "We're not getting 98% of people anyway, and I think [home treatment] is an idea whose time has come, and I think it's going to take off. Buying this device will cost less than a single treatment in my office."

A patient's underarm area is shown above before hair removal treatment.

The same underarm is shown 1 month after self-administration of the device.

CHICAGO — A new low-energy, pulsed-light device promises a safe way for women to do their own long-term hair removal at home for the first time, according to Dr. Tina Alster.

The handheld device was tested for safety and efficacy by 20 women aged 32-56 years, with Fitzpatrick skin types 1 through 5 and brown or black terminal hair, Dr. Alster said at the annual meeting of the American Society for Dermatologic Surgery.

The device manufacturer recently submitted the product for 510(k) clearance from the Food and Drug Administration, but a decision is not expected before the end of the year, according to company spokesman Tom Goslau. The Silk'n hair removal device (HomeSkinovations Ltd., Tel Aviv) emits wavelengths of 475-1,200 nm and fluences up to 5 J/mm2.

Hair removal is the top skin treatment worldwide, with total annual sales approaching $9 billion, said Dr. Alster, who is medical director of the Washington (D.C.) Institute of Dermatologic Laser Surgery.

"The low end of the market—shaving and waxing—constitutes $5.7 billion of the total, with the remaining $3 billion coming from high-end procedures such as laser and light treatment," she said, adding that only 2% of the population can afford professional treatment.

Of the 20 women, 7 treated themselves under the axillary region, 3 on the forearm, 5 in the inguinal region, and 5 on the lower legs. "All women self-administered three or four light treatments at 2-week intervals in our office so that we could make sure they weren't using the device more often than necessary," Dr. Alster said.

"We saw hair reductions ranging from 40% to 75%, with the legs and arms responding slightly better than the underarm and bikini region," she said in an interview, adding that the return of hair was slightly higher on the legs, though lower-leg hair reduction averaged 61% at 3-month follow-up. And unlike some earlier experimental devices, the Silk'n caused no complications or pain.

Respectively, the 1- and 3-month hair removal results were axillae, 48% and 42%; arms, 59% and 58%; inguinal area, 48% and 40%; and legs, 73.5% and 61%.

"This pulsed-light unit is portable, lightweight, has an internal cooling fan, uses regular household current, provides a light pulse every 3.5 seconds, and is self-contained, making protective eyewear unnecessary," explained Dr. Alster, who has conducted research for Zars Pharma and Galderma.

The equipment used in this study was provided by HomeSkinovations.

If clearance is received, the Silk'n will go on the market at a price of between $250 and $500, she said. "My guess is that many of those who have been getting hair removal treatments at spas will purchase these devices and do this in the privacy of their homes."

Home hair removal equipment will not have much financial effect on dermatology, Dr. Alster predicted. "We're not getting 98% of people anyway, and I think [home treatment] is an idea whose time has come, and I think it's going to take off. Buying this device will cost less than a single treatment in my office."

A patient's underarm area is shown above before hair removal treatment.

The same underarm is shown 1 month after self-administration of the device.

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All Patients Should Receive Complete Skin Exam

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CHICAGO — Dermatologists who conducted complete skin examinations of all their patients would detect more melanomas, and those cancers would be detected earlier, Dr. Jonathan Kantor said at the annual meeting of the American Society for Dermatologic Surgery.

"Full skin examination is a critical tool for detecting melanoma in patients visiting a dermatology or dermatologic surgery office," said Dr. Jonathan Kantor, who is in private practice in Jacksonville, Fla.

According to one published survey, only about 30% of dermatologists perform full skin examinations on all their patients, and half of respondents said that they screened only those patients deemed to be at increased risk (J. Am. Acad. Dermatol. 2002;46:710-4).

This survey "suggests that half of dermatologists are not screening patients at high risk of melanoma," said Dr. Kantor.

"Clearly, we cannot find all melanomas just by saying "hello," shaking the patient's hand, and talking to him about his acne. We know that when we screen patients actively, we're going to find melanomas at earlier stages," he said.

For this study, Dr. Kantor drew on 2 years of data on 76 consecutive patients who were diagnosed in an office setting, either with invasive melanoma (30) or melanoma in situ (46). Their average age was 60 years; 63% were men.

A total of 41 patients (54%) had made appointments because they saw something suspicious on their skin and thought it should be looked at. The remaining 35 (46%) came in for other reasons, such as acne, dry skin, warts, and other conditions, he explained.

Body locations for the melanomas were fairly evenly distributed among the head and neck, trunk, and extremities, with the lower extremities being slightly less represented. The trunk was the most common site of melanomas in men, but the legs were the most common site for women.

Dr. Kantor concluded that 46% of all the melanomas (43% of invasive melanomas and 48% of in situ lesions) may not have been found without the careful skin examination.

Physician-detected melanomas tended to be thinner, and at the in situ stage; although these trends were not statistically significant, they highlight the clinical validity of the study data. "It makes sense that screening finds melanoma earlier and at a stage where hopefully they're more likely to respond to treatment," Dr. Kantor said.

Although he believes that this study has implications for both clinical practice and health policy—including screening recommendations—he conceded its important limitations. "Obviously, these data are not generalizable and this was a retrospective analytical case series, which limits further analysis. Also, there's the issue of screening versus examination. Those who are examined in a physician's office may be at higher risk than those who attend skin cancer screenings," he said.

Yet, he added, dermatologists should consider doing complete skin examinations on all patients and let future studies fill in the gaps left by this initial research.

The U.S. Preventive Services Task Force has concluded that there is insufficient evidence to recommend for or against routine screening for skin cancer using a total body examination.

"One of my main jobs as a dermatologist is to find melanoma and melanoma in situ, because early detection is an inconvenience while late detection becomes a tragedy," Dr. Kantor said, pointing out that the 10-year survival rate drops from 88% for a 1-mm melanoma to 32% for an ulcerated melanoma larger than 4 mm.

And melanoma in situ should never be underestimated, he added, explaining that in a study of 104 reassessed patients, almost a third of melanomas in situ were reclassified as invasive melanoma (Lancet 2002;359:1921-2).

This melanoma in situ was found on the foot of an 88-year-old who presented with a complaint of dry skin. Her toe was saved with geometric excision. Courtesy Dr. Jonathan Kantor

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CHICAGO — Dermatologists who conducted complete skin examinations of all their patients would detect more melanomas, and those cancers would be detected earlier, Dr. Jonathan Kantor said at the annual meeting of the American Society for Dermatologic Surgery.

"Full skin examination is a critical tool for detecting melanoma in patients visiting a dermatology or dermatologic surgery office," said Dr. Jonathan Kantor, who is in private practice in Jacksonville, Fla.

According to one published survey, only about 30% of dermatologists perform full skin examinations on all their patients, and half of respondents said that they screened only those patients deemed to be at increased risk (J. Am. Acad. Dermatol. 2002;46:710-4).

This survey "suggests that half of dermatologists are not screening patients at high risk of melanoma," said Dr. Kantor.

"Clearly, we cannot find all melanomas just by saying "hello," shaking the patient's hand, and talking to him about his acne. We know that when we screen patients actively, we're going to find melanomas at earlier stages," he said.

For this study, Dr. Kantor drew on 2 years of data on 76 consecutive patients who were diagnosed in an office setting, either with invasive melanoma (30) or melanoma in situ (46). Their average age was 60 years; 63% were men.

A total of 41 patients (54%) had made appointments because they saw something suspicious on their skin and thought it should be looked at. The remaining 35 (46%) came in for other reasons, such as acne, dry skin, warts, and other conditions, he explained.

Body locations for the melanomas were fairly evenly distributed among the head and neck, trunk, and extremities, with the lower extremities being slightly less represented. The trunk was the most common site of melanomas in men, but the legs were the most common site for women.

Dr. Kantor concluded that 46% of all the melanomas (43% of invasive melanomas and 48% of in situ lesions) may not have been found without the careful skin examination.

Physician-detected melanomas tended to be thinner, and at the in situ stage; although these trends were not statistically significant, they highlight the clinical validity of the study data. "It makes sense that screening finds melanoma earlier and at a stage where hopefully they're more likely to respond to treatment," Dr. Kantor said.

Although he believes that this study has implications for both clinical practice and health policy—including screening recommendations—he conceded its important limitations. "Obviously, these data are not generalizable and this was a retrospective analytical case series, which limits further analysis. Also, there's the issue of screening versus examination. Those who are examined in a physician's office may be at higher risk than those who attend skin cancer screenings," he said.

Yet, he added, dermatologists should consider doing complete skin examinations on all patients and let future studies fill in the gaps left by this initial research.

The U.S. Preventive Services Task Force has concluded that there is insufficient evidence to recommend for or against routine screening for skin cancer using a total body examination.

"One of my main jobs as a dermatologist is to find melanoma and melanoma in situ, because early detection is an inconvenience while late detection becomes a tragedy," Dr. Kantor said, pointing out that the 10-year survival rate drops from 88% for a 1-mm melanoma to 32% for an ulcerated melanoma larger than 4 mm.

And melanoma in situ should never be underestimated, he added, explaining that in a study of 104 reassessed patients, almost a third of melanomas in situ were reclassified as invasive melanoma (Lancet 2002;359:1921-2).

This melanoma in situ was found on the foot of an 88-year-old who presented with a complaint of dry skin. Her toe was saved with geometric excision. Courtesy Dr. Jonathan Kantor

CHICAGO — Dermatologists who conducted complete skin examinations of all their patients would detect more melanomas, and those cancers would be detected earlier, Dr. Jonathan Kantor said at the annual meeting of the American Society for Dermatologic Surgery.

"Full skin examination is a critical tool for detecting melanoma in patients visiting a dermatology or dermatologic surgery office," said Dr. Jonathan Kantor, who is in private practice in Jacksonville, Fla.

According to one published survey, only about 30% of dermatologists perform full skin examinations on all their patients, and half of respondents said that they screened only those patients deemed to be at increased risk (J. Am. Acad. Dermatol. 2002;46:710-4).

This survey "suggests that half of dermatologists are not screening patients at high risk of melanoma," said Dr. Kantor.

"Clearly, we cannot find all melanomas just by saying "hello," shaking the patient's hand, and talking to him about his acne. We know that when we screen patients actively, we're going to find melanomas at earlier stages," he said.

For this study, Dr. Kantor drew on 2 years of data on 76 consecutive patients who were diagnosed in an office setting, either with invasive melanoma (30) or melanoma in situ (46). Their average age was 60 years; 63% were men.

A total of 41 patients (54%) had made appointments because they saw something suspicious on their skin and thought it should be looked at. The remaining 35 (46%) came in for other reasons, such as acne, dry skin, warts, and other conditions, he explained.

Body locations for the melanomas were fairly evenly distributed among the head and neck, trunk, and extremities, with the lower extremities being slightly less represented. The trunk was the most common site of melanomas in men, but the legs were the most common site for women.

Dr. Kantor concluded that 46% of all the melanomas (43% of invasive melanomas and 48% of in situ lesions) may not have been found without the careful skin examination.

Physician-detected melanomas tended to be thinner, and at the in situ stage; although these trends were not statistically significant, they highlight the clinical validity of the study data. "It makes sense that screening finds melanoma earlier and at a stage where hopefully they're more likely to respond to treatment," Dr. Kantor said.

Although he believes that this study has implications for both clinical practice and health policy—including screening recommendations—he conceded its important limitations. "Obviously, these data are not generalizable and this was a retrospective analytical case series, which limits further analysis. Also, there's the issue of screening versus examination. Those who are examined in a physician's office may be at higher risk than those who attend skin cancer screenings," he said.

Yet, he added, dermatologists should consider doing complete skin examinations on all patients and let future studies fill in the gaps left by this initial research.

The U.S. Preventive Services Task Force has concluded that there is insufficient evidence to recommend for or against routine screening for skin cancer using a total body examination.

"One of my main jobs as a dermatologist is to find melanoma and melanoma in situ, because early detection is an inconvenience while late detection becomes a tragedy," Dr. Kantor said, pointing out that the 10-year survival rate drops from 88% for a 1-mm melanoma to 32% for an ulcerated melanoma larger than 4 mm.

And melanoma in situ should never be underestimated, he added, explaining that in a study of 104 reassessed patients, almost a third of melanomas in situ were reclassified as invasive melanoma (Lancet 2002;359:1921-2).

This melanoma in situ was found on the foot of an 88-year-old who presented with a complaint of dry skin. Her toe was saved with geometric excision. Courtesy Dr. Jonathan Kantor

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Pulsed Dye Laser Clears BCCs,Small Study Finds

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CHICAGO — Pulsed dye lasers may add a third option to the realm of treatments for superficial and nodular basal cell carcinomas less than 1.5 cm in diameter, according to Dr. Zeina Tannous, who performed a study of the treatment in 14 patients.

Unlike surgical excision or Mohs micrographic surgery, pulsed dye lasers selectively target vessels, said Dr. Tannous of Harvard Medical School, Boston, and chief of Mohs micrographic surgery at the Veterans Administration Hospital in Boston.

"Pulsed dye laser may allow for selective photothermolysis of pathological blood vessels and thus could be a nonsurgical treatment method for basal cell carcinomas, and this is important in patients with multiple tumors for whom surgery may be risky."

In her study, presented at the annual meeting of the American Society for Dermatologic Surgery, Dr. Tannous and her colleagues treated 14 patients with 23 biopsy-proven primary basal cell carcinomas (BCCs) located on their extremities and trunk. None of the patients had recurrent or infiltrative lesions. The BCCs ranged in diameter from 0.5 cm to 7 cm, and most were on the trunk.

All but two patients received four laser treatments at intervals of at least 2 weeks. The wavelength used was 595 nm at 15 J/cm2, with pulse durations of 3 milliseconds and a 7-mm minimally overlapping spot size with a single pass and no dynamic cooling.

Two weeks after the final laser treatment, the BCCs were removed by disk incision, and the tissue was stained using hematoxylin and eosin to observe the histologic response to treatment.

Interestingly, the two patients who did not receive the full four laser treatments—one received a single treatment and the other underwent three treatments—had no residual BCC in their excised lesions, Dr. Tannous said. A complete response was no residual basal cell carcinoma findings in excised tissue; incomplete response was evidence of any residual basal cells.

Of the 21 treated tumors, 13 (62%) completely responded. In a comparison, complete responses were seen in 2 of 21 control tumors that underwent diagnostic biopsy before being excised and were matched to the study lesions for size, histologic type, and location. "This [observation] proved that the response we're seeing is due to the selective laser treatment, and not due to the nonspecific inflammation related to the diagnostic biopsy," she explained.

Size appeared to be associated with the probability of a complete response to laser treatment. The average BCC was 1.1 cm in the complete responders and 2.8 cm in the incomplete responders.

Based on diameter, all small BCCs (under 0.7 cm) cleared completely; medium BCCs (0.7-1.4 cm) cleared completely in 92%; and large lesions (more than 1.4 cm) cleared in 22%.

At greater than 90%, the complete clearance rate for small and medium lesions treated by laser was significantly higher than the 61% rate seen in the matched controls.

"While these data show promise for the use of PDL [pulsed dye laser] in the treatment of both superficial and nodular basal cell carcinomas smaller than 1.5 cm, we cannot make clinical recommendations until we've completed a larger study with more patients," Dr. Tannous concluded.

Continued research should also demonstrate whether more treatment sessions would produce better results for larger BCCs.

Dr. Tannous reported having no conflicts of interest.

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CHICAGO — Pulsed dye lasers may add a third option to the realm of treatments for superficial and nodular basal cell carcinomas less than 1.5 cm in diameter, according to Dr. Zeina Tannous, who performed a study of the treatment in 14 patients.

Unlike surgical excision or Mohs micrographic surgery, pulsed dye lasers selectively target vessels, said Dr. Tannous of Harvard Medical School, Boston, and chief of Mohs micrographic surgery at the Veterans Administration Hospital in Boston.

"Pulsed dye laser may allow for selective photothermolysis of pathological blood vessels and thus could be a nonsurgical treatment method for basal cell carcinomas, and this is important in patients with multiple tumors for whom surgery may be risky."

In her study, presented at the annual meeting of the American Society for Dermatologic Surgery, Dr. Tannous and her colleagues treated 14 patients with 23 biopsy-proven primary basal cell carcinomas (BCCs) located on their extremities and trunk. None of the patients had recurrent or infiltrative lesions. The BCCs ranged in diameter from 0.5 cm to 7 cm, and most were on the trunk.

All but two patients received four laser treatments at intervals of at least 2 weeks. The wavelength used was 595 nm at 15 J/cm2, with pulse durations of 3 milliseconds and a 7-mm minimally overlapping spot size with a single pass and no dynamic cooling.

Two weeks after the final laser treatment, the BCCs were removed by disk incision, and the tissue was stained using hematoxylin and eosin to observe the histologic response to treatment.

Interestingly, the two patients who did not receive the full four laser treatments—one received a single treatment and the other underwent three treatments—had no residual BCC in their excised lesions, Dr. Tannous said. A complete response was no residual basal cell carcinoma findings in excised tissue; incomplete response was evidence of any residual basal cells.

Of the 21 treated tumors, 13 (62%) completely responded. In a comparison, complete responses were seen in 2 of 21 control tumors that underwent diagnostic biopsy before being excised and were matched to the study lesions for size, histologic type, and location. "This [observation] proved that the response we're seeing is due to the selective laser treatment, and not due to the nonspecific inflammation related to the diagnostic biopsy," she explained.

Size appeared to be associated with the probability of a complete response to laser treatment. The average BCC was 1.1 cm in the complete responders and 2.8 cm in the incomplete responders.

Based on diameter, all small BCCs (under 0.7 cm) cleared completely; medium BCCs (0.7-1.4 cm) cleared completely in 92%; and large lesions (more than 1.4 cm) cleared in 22%.

At greater than 90%, the complete clearance rate for small and medium lesions treated by laser was significantly higher than the 61% rate seen in the matched controls.

"While these data show promise for the use of PDL [pulsed dye laser] in the treatment of both superficial and nodular basal cell carcinomas smaller than 1.5 cm, we cannot make clinical recommendations until we've completed a larger study with more patients," Dr. Tannous concluded.

Continued research should also demonstrate whether more treatment sessions would produce better results for larger BCCs.

Dr. Tannous reported having no conflicts of interest.

CHICAGO — Pulsed dye lasers may add a third option to the realm of treatments for superficial and nodular basal cell carcinomas less than 1.5 cm in diameter, according to Dr. Zeina Tannous, who performed a study of the treatment in 14 patients.

Unlike surgical excision or Mohs micrographic surgery, pulsed dye lasers selectively target vessels, said Dr. Tannous of Harvard Medical School, Boston, and chief of Mohs micrographic surgery at the Veterans Administration Hospital in Boston.

"Pulsed dye laser may allow for selective photothermolysis of pathological blood vessels and thus could be a nonsurgical treatment method for basal cell carcinomas, and this is important in patients with multiple tumors for whom surgery may be risky."

In her study, presented at the annual meeting of the American Society for Dermatologic Surgery, Dr. Tannous and her colleagues treated 14 patients with 23 biopsy-proven primary basal cell carcinomas (BCCs) located on their extremities and trunk. None of the patients had recurrent or infiltrative lesions. The BCCs ranged in diameter from 0.5 cm to 7 cm, and most were on the trunk.

All but two patients received four laser treatments at intervals of at least 2 weeks. The wavelength used was 595 nm at 15 J/cm2, with pulse durations of 3 milliseconds and a 7-mm minimally overlapping spot size with a single pass and no dynamic cooling.

Two weeks after the final laser treatment, the BCCs were removed by disk incision, and the tissue was stained using hematoxylin and eosin to observe the histologic response to treatment.

Interestingly, the two patients who did not receive the full four laser treatments—one received a single treatment and the other underwent three treatments—had no residual BCC in their excised lesions, Dr. Tannous said. A complete response was no residual basal cell carcinoma findings in excised tissue; incomplete response was evidence of any residual basal cells.

Of the 21 treated tumors, 13 (62%) completely responded. In a comparison, complete responses were seen in 2 of 21 control tumors that underwent diagnostic biopsy before being excised and were matched to the study lesions for size, histologic type, and location. "This [observation] proved that the response we're seeing is due to the selective laser treatment, and not due to the nonspecific inflammation related to the diagnostic biopsy," she explained.

Size appeared to be associated with the probability of a complete response to laser treatment. The average BCC was 1.1 cm in the complete responders and 2.8 cm in the incomplete responders.

Based on diameter, all small BCCs (under 0.7 cm) cleared completely; medium BCCs (0.7-1.4 cm) cleared completely in 92%; and large lesions (more than 1.4 cm) cleared in 22%.

At greater than 90%, the complete clearance rate for small and medium lesions treated by laser was significantly higher than the 61% rate seen in the matched controls.

"While these data show promise for the use of PDL [pulsed dye laser] in the treatment of both superficial and nodular basal cell carcinomas smaller than 1.5 cm, we cannot make clinical recommendations until we've completed a larger study with more patients," Dr. Tannous concluded.

Continued research should also demonstrate whether more treatment sessions would produce better results for larger BCCs.

Dr. Tannous reported having no conflicts of interest.

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Address Physical Inactivity Before Age 18 Years

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CHICAGO — Primary care physicians are well positioned to help reverse the trends of physical inactivity and obesity in all age groups, according to fitness authorities at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Physicians should motivate their patients to engage in regular appropriate exercise and the sooner, the better, Col. Brian K. Unwin, MC, USA, told the annual meeting the American Academy of Family Physicians.

It's estimated that 66% of adults are overweight or obese and one-half of children and adolescents are overweight or are at risk of becoming overweight, according to the Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health (Epidemiol. Rev. 2007;29:6–28). By 2015, three-quarters of adults will be overweight or obese, and 41% of children and adolescents will be obese, according to the latest projections.

The optimal time to address the issue with patients is before they reach the age of 18, said Maj. Anthony Beutler, MC, USA, chief of the USU Injury Prevention Research Laboratory. Dr. Beutler and Dr. Unwin are with the university's F. Edward Hébert School of Medicine.

“In certain populations, up to 45% of new diabetes mellitus cases in young people aged 10–19 years are type 2 disease,” Dr. Beutler said.

A quarter of obese preschoolers become obese adults, and the remaining three-quarters become normal-weight adults. However, 80% of obese 14-year-olds remain obese as adults, and nearly three-fourths of obese children who lose weight will maintain that loss as adults.

“We have an opportunity to make important changes before this window closes … between the ages of 14 and 18 years,” Dr. Beutler said. “Getting the adults to change can be tremendously difficult and time consuming, but we can look for people who are ready to change or are contemplating being more active. But with children, we can make a huge difference that has a lasting effect.”

Many physicians are reluctant to address behavior modification with their patients, often viewing the effort as too time consuming or ineffective, or they may lack confidence in their ability to change patient behavior.

Dr. Beutler and Dr. Unwin recommend that physicians adopt an action plan first published in 2006 by researchers at the University of California San Francisco (J. Am. Board Med. 2006;19:215–23). The same researchers subsequently applied their plan to helping patients adopt more healthful behaviors (Clinical Diabetes 2007;25:66–70).

They emphasized physician-patient collaboration in working toward behavior modification. “After a patient has agreed on a general goal, the patient and caregivers negotiate a specific action plan to assist in goal attainment,” they wrote. For example, if the goal is to get more exercise, the plan may include specific aerobic and resistance training targets. The action plan is available at www.familymedicine.medschool.ucsf.edu/community_service/actionPlan.aspx

To increase the likelihood that patients will succeed, they're asked to rate the importance of behavior change and exercise, then to estimate how confident they are that they can carry out their action plan, using a scale of 0–10. Doubts about either can be allayed through further discussions that may extend over several patient visits.

Dr. Beutler prefers to think of physical activity more in terms of fitness rather than solely as a means of losing weight. “There's strong evidence from several studies that being fit reduces the risk of disease no matter what your body mass index is,” he said.

Before your patient heads for the gym, be sure to assess his baseline fitness so that he can proceed without becoming discouraged or suffering pain or injury, Dr. Beutler explained, adding that the American College of Sports Medicine offers useful guidelines for determining risk and setting reasonable goals.

Healthy men under age 45 and women younger than 55 fall into the low-risk category. Risk increases with age, and also with conditions such as diabetes and cardiac disease. Having an HDL-cholesterol level of 60 mg/dL tends to counteract risk factors, he said.

“Low-risk people don't need a treadmill test before starting to exercise and high-risk patients should always be screened. Testing also is suggested for moderate-risk individuals who plan a vigorous exercise routine. “Always screen patients with signs or symptoms of cardiac disease or known metabolic or pulmonary disease,” he said.

In the case of sedentary elderly patients, in whom obesity is much less of an issue, more stress is placed on preserving function and independence, Dr. Unwin said.

The elite or competitive athlete has a high aerobic capacity that begins to decline with age, but always remains higher than that of the average weekend warrior, whose break in aerobic capacity occurs earlier and more dramatically, he explained. “But if we add exercise to the equation, we can help that older person regain a lot of that capacity and start a new curve.”

 

 

In addition to aerobics, exercise regimens need to include resistance training, static and dynamic balance exercises, and stretching to maintain flexibility. “Sedentary people lose 20%–40% of their muscle mass, or about 6% a decade past age 20. However, walking and running don't address this, and that's why strength-building resistance training is so important as we age,” Dr. Unwin said.

With a regular workout program, a sedentary older adult can increase his or her strength anywhere from 40% to 150%, “and that can mean the difference between walking to the mailbox and going up and down stairs, or going directly to assisted living … or to a nursing home,” he said.

It's important that the planned exercise routine be based on the participant's self-perceived level of exertion, rather than on an arbitrarily set regimen. “If we can get our patients to maintain their strength as well as their aerobic capacity, we'll be intervening on these geriatric syndromes of falls, frailty, sarcopenia, and loss of function,” he said.

Being physically active and fit can help to reduce the risk of disease, irrespective of one's body mass index. Lynda Banzi/Elsevier Global Medical News

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CHICAGO — Primary care physicians are well positioned to help reverse the trends of physical inactivity and obesity in all age groups, according to fitness authorities at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Physicians should motivate their patients to engage in regular appropriate exercise and the sooner, the better, Col. Brian K. Unwin, MC, USA, told the annual meeting the American Academy of Family Physicians.

It's estimated that 66% of adults are overweight or obese and one-half of children and adolescents are overweight or are at risk of becoming overweight, according to the Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health (Epidemiol. Rev. 2007;29:6–28). By 2015, three-quarters of adults will be overweight or obese, and 41% of children and adolescents will be obese, according to the latest projections.

The optimal time to address the issue with patients is before they reach the age of 18, said Maj. Anthony Beutler, MC, USA, chief of the USU Injury Prevention Research Laboratory. Dr. Beutler and Dr. Unwin are with the university's F. Edward Hébert School of Medicine.

“In certain populations, up to 45% of new diabetes mellitus cases in young people aged 10–19 years are type 2 disease,” Dr. Beutler said.

A quarter of obese preschoolers become obese adults, and the remaining three-quarters become normal-weight adults. However, 80% of obese 14-year-olds remain obese as adults, and nearly three-fourths of obese children who lose weight will maintain that loss as adults.

“We have an opportunity to make important changes before this window closes … between the ages of 14 and 18 years,” Dr. Beutler said. “Getting the adults to change can be tremendously difficult and time consuming, but we can look for people who are ready to change or are contemplating being more active. But with children, we can make a huge difference that has a lasting effect.”

Many physicians are reluctant to address behavior modification with their patients, often viewing the effort as too time consuming or ineffective, or they may lack confidence in their ability to change patient behavior.

Dr. Beutler and Dr. Unwin recommend that physicians adopt an action plan first published in 2006 by researchers at the University of California San Francisco (J. Am. Board Med. 2006;19:215–23). The same researchers subsequently applied their plan to helping patients adopt more healthful behaviors (Clinical Diabetes 2007;25:66–70).

They emphasized physician-patient collaboration in working toward behavior modification. “After a patient has agreed on a general goal, the patient and caregivers negotiate a specific action plan to assist in goal attainment,” they wrote. For example, if the goal is to get more exercise, the plan may include specific aerobic and resistance training targets. The action plan is available at www.familymedicine.medschool.ucsf.edu/community_service/actionPlan.aspx

To increase the likelihood that patients will succeed, they're asked to rate the importance of behavior change and exercise, then to estimate how confident they are that they can carry out their action plan, using a scale of 0–10. Doubts about either can be allayed through further discussions that may extend over several patient visits.

Dr. Beutler prefers to think of physical activity more in terms of fitness rather than solely as a means of losing weight. “There's strong evidence from several studies that being fit reduces the risk of disease no matter what your body mass index is,” he said.

Before your patient heads for the gym, be sure to assess his baseline fitness so that he can proceed without becoming discouraged or suffering pain or injury, Dr. Beutler explained, adding that the American College of Sports Medicine offers useful guidelines for determining risk and setting reasonable goals.

Healthy men under age 45 and women younger than 55 fall into the low-risk category. Risk increases with age, and also with conditions such as diabetes and cardiac disease. Having an HDL-cholesterol level of 60 mg/dL tends to counteract risk factors, he said.

“Low-risk people don't need a treadmill test before starting to exercise and high-risk patients should always be screened. Testing also is suggested for moderate-risk individuals who plan a vigorous exercise routine. “Always screen patients with signs or symptoms of cardiac disease or known metabolic or pulmonary disease,” he said.

In the case of sedentary elderly patients, in whom obesity is much less of an issue, more stress is placed on preserving function and independence, Dr. Unwin said.

The elite or competitive athlete has a high aerobic capacity that begins to decline with age, but always remains higher than that of the average weekend warrior, whose break in aerobic capacity occurs earlier and more dramatically, he explained. “But if we add exercise to the equation, we can help that older person regain a lot of that capacity and start a new curve.”

 

 

In addition to aerobics, exercise regimens need to include resistance training, static and dynamic balance exercises, and stretching to maintain flexibility. “Sedentary people lose 20%–40% of their muscle mass, or about 6% a decade past age 20. However, walking and running don't address this, and that's why strength-building resistance training is so important as we age,” Dr. Unwin said.

With a regular workout program, a sedentary older adult can increase his or her strength anywhere from 40% to 150%, “and that can mean the difference between walking to the mailbox and going up and down stairs, or going directly to assisted living … or to a nursing home,” he said.

It's important that the planned exercise routine be based on the participant's self-perceived level of exertion, rather than on an arbitrarily set regimen. “If we can get our patients to maintain their strength as well as their aerobic capacity, we'll be intervening on these geriatric syndromes of falls, frailty, sarcopenia, and loss of function,” he said.

Being physically active and fit can help to reduce the risk of disease, irrespective of one's body mass index. Lynda Banzi/Elsevier Global Medical News

CHICAGO — Primary care physicians are well positioned to help reverse the trends of physical inactivity and obesity in all age groups, according to fitness authorities at the Uniformed Services University of the Health Sciences in Bethesda, Md.

Physicians should motivate their patients to engage in regular appropriate exercise and the sooner, the better, Col. Brian K. Unwin, MC, USA, told the annual meeting the American Academy of Family Physicians.

It's estimated that 66% of adults are overweight or obese and one-half of children and adolescents are overweight or are at risk of becoming overweight, according to the Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health (Epidemiol. Rev. 2007;29:6–28). By 2015, three-quarters of adults will be overweight or obese, and 41% of children and adolescents will be obese, according to the latest projections.

The optimal time to address the issue with patients is before they reach the age of 18, said Maj. Anthony Beutler, MC, USA, chief of the USU Injury Prevention Research Laboratory. Dr. Beutler and Dr. Unwin are with the university's F. Edward Hébert School of Medicine.

“In certain populations, up to 45% of new diabetes mellitus cases in young people aged 10–19 years are type 2 disease,” Dr. Beutler said.

A quarter of obese preschoolers become obese adults, and the remaining three-quarters become normal-weight adults. However, 80% of obese 14-year-olds remain obese as adults, and nearly three-fourths of obese children who lose weight will maintain that loss as adults.

“We have an opportunity to make important changes before this window closes … between the ages of 14 and 18 years,” Dr. Beutler said. “Getting the adults to change can be tremendously difficult and time consuming, but we can look for people who are ready to change or are contemplating being more active. But with children, we can make a huge difference that has a lasting effect.”

Many physicians are reluctant to address behavior modification with their patients, often viewing the effort as too time consuming or ineffective, or they may lack confidence in their ability to change patient behavior.

Dr. Beutler and Dr. Unwin recommend that physicians adopt an action plan first published in 2006 by researchers at the University of California San Francisco (J. Am. Board Med. 2006;19:215–23). The same researchers subsequently applied their plan to helping patients adopt more healthful behaviors (Clinical Diabetes 2007;25:66–70).

They emphasized physician-patient collaboration in working toward behavior modification. “After a patient has agreed on a general goal, the patient and caregivers negotiate a specific action plan to assist in goal attainment,” they wrote. For example, if the goal is to get more exercise, the plan may include specific aerobic and resistance training targets. The action plan is available at www.familymedicine.medschool.ucsf.edu/community_service/actionPlan.aspx

To increase the likelihood that patients will succeed, they're asked to rate the importance of behavior change and exercise, then to estimate how confident they are that they can carry out their action plan, using a scale of 0–10. Doubts about either can be allayed through further discussions that may extend over several patient visits.

Dr. Beutler prefers to think of physical activity more in terms of fitness rather than solely as a means of losing weight. “There's strong evidence from several studies that being fit reduces the risk of disease no matter what your body mass index is,” he said.

Before your patient heads for the gym, be sure to assess his baseline fitness so that he can proceed without becoming discouraged or suffering pain or injury, Dr. Beutler explained, adding that the American College of Sports Medicine offers useful guidelines for determining risk and setting reasonable goals.

Healthy men under age 45 and women younger than 55 fall into the low-risk category. Risk increases with age, and also with conditions such as diabetes and cardiac disease. Having an HDL-cholesterol level of 60 mg/dL tends to counteract risk factors, he said.

“Low-risk people don't need a treadmill test before starting to exercise and high-risk patients should always be screened. Testing also is suggested for moderate-risk individuals who plan a vigorous exercise routine. “Always screen patients with signs or symptoms of cardiac disease or known metabolic or pulmonary disease,” he said.

In the case of sedentary elderly patients, in whom obesity is much less of an issue, more stress is placed on preserving function and independence, Dr. Unwin said.

The elite or competitive athlete has a high aerobic capacity that begins to decline with age, but always remains higher than that of the average weekend warrior, whose break in aerobic capacity occurs earlier and more dramatically, he explained. “But if we add exercise to the equation, we can help that older person regain a lot of that capacity and start a new curve.”

 

 

In addition to aerobics, exercise regimens need to include resistance training, static and dynamic balance exercises, and stretching to maintain flexibility. “Sedentary people lose 20%–40% of their muscle mass, or about 6% a decade past age 20. However, walking and running don't address this, and that's why strength-building resistance training is so important as we age,” Dr. Unwin said.

With a regular workout program, a sedentary older adult can increase his or her strength anywhere from 40% to 150%, “and that can mean the difference between walking to the mailbox and going up and down stairs, or going directly to assisted living … or to a nursing home,” he said.

It's important that the planned exercise routine be based on the participant's self-perceived level of exertion, rather than on an arbitrarily set regimen. “If we can get our patients to maintain their strength as well as their aerobic capacity, we'll be intervening on these geriatric syndromes of falls, frailty, sarcopenia, and loss of function,” he said.

Being physically active and fit can help to reduce the risk of disease, irrespective of one's body mass index. Lynda Banzi/Elsevier Global Medical News

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