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Bioterrorism and Vaccine Events Remain Threats
SCOTTSDALE, ARIZ. — Despite the grateful lull that has followed Sept. 11 and the anthrax scare in 2001, bioterrorism remains a very real threat, according to a Food and Drug Administration counterterrorism official.
Dr. Boris Lushniak, the FDA's assistant commissioner for counterterrorism policy and assistant U.S. surgeon general, hopes that vigilance remains active in medical offices and emergency departments across the United States—but he has his doubts.
“I daresay we are going to be caught off guard,” Dr. Lushniak said during the Alfred L. Weiner Lecture at the annual meeting of the Noah Worcester Dermatological Society.
A disturbing number of organisms meet all or some of the criteria for an ideal agent of biological terrorism: easy to obtain and work with, inexpensive to produce, able to be widely disseminated, fairly stable in the environment, capable of producing high morbidity and mortality, transmissible from person to person, and difficult to diagnose and treat, which would allow an attack to quickly overwhelm the health care system.
On a positive note, the U.S. government has now stockpiled enough vaccine against smallpox to inoculate every man, woman, and child in the country, Dr. Lushniak reported.
On the other hand, when U.S. public health authorities were notified recently about an individual with suspicious skin lesions on an inbound flight from China, they were unable to find any hospital in a major metropolitan area willing to admit and quarantine the 200 people aboard until danger to the public was ruled out.
Fortunately, in that case, the threat was nullified during 4 hours of frantic planning as the airliner approached U.S. shores, but it stands as a wake-up call about preparedness. “We really have to change the way we do our business,” he said.
The potential agents of greatest concern—labeled category A by the Centers for Disease Control and Prevention—remain the same as ever: anthrax, smallpox, plague, tularemia, viral hemorrhagic fevers, and botulinum toxin.
“All suspicious or confirmed cases should be reported to health authorities immediately,” Dr. Lushniak said.
“We should all have that high level of suspicion. If you're worried, if you think it's part of your differential, you really should give someone a call. It may be a false alarm, may be overreading, but … really what we're looking for is someone to be able to ring that first fire alarm,” he said.
The timing could be critical.
Anthrax, for example, can be controlled with antibiotics if it is recognized and treated with postexposure prophylaxis before protein-rich toxins are produced by the organism. “If you can nip it in the spore bud, so to speak, then you really have solved the problem,” he said.
The disease is heralded by a flulike prodrome, progressing to hypoxia, dyspnea, and, often, mediastinal widening on x-ray.
He reminded dermatologists of the clinical presentation of cutaneous anthrax exposure following a 1- to 12-day incubation period. The presenting symptom might be tender pruritic macules that evolve into papules, which progress to vesicles and bullae formation in 24–48 hours. Bullae may rupture when they reach 1–2 cm. Eventually, telltale black necrotic ulcers may be seen, with a black eschar visible by day 6.
Differential diagnoses for cutaneous anthrax include brown recluse spider bites, ecthyma gangrenosum, tularemia, staph infections, and herpes labialis.
If smallpox is ever used in a bioterrorist attack, the tip-off may be its severe prodrome, which follows a noninfectious incubation period lasting 7–17 days, Dr. Lushniak said.
For 2–4 days, infected patients have very high fevers (101° F-104° F), prostration, myalgias, and malaise as small red macules and papules begin to form and even ulcerate on the tongue and mouth. An exanthem then appears in a centrifugal pattern on the face, arms, hands, legs, and feet. Macules form, then papules. By day 5, tense, often umbilicated vesicles can be seen that look like “BB pellets embedded in the skin,” he noted.
By day 6–12, pustules begin to form crusts that remain intact throughout a long period of infection until they separate at about day 28, leaving depressed scars.
Differential diagnoses include varicella, molluscum contagiosum, hand-foot-and-mouth disease, disseminated herpes simplex virus, herpes zoster, pustular drug eruptions, and scabies.
“If this were to come back into the world, the feeling is that at least the prodrome may keep people at home, in bed,” he said.
Even preventive efforts aimed at a potential bioterrorism attack have health implications that physicians should recognize, Dr. Lushniak said.
He described a 2007 case of household transmission of the live virus through a smallpox vaccine. Within a month of the father having received a smallpox vaccination prior to military deployment overseas, he came into contact with his infant son, who had eczema.
Although the father's vaccine site was covered during the unplanned visit, the child developed a high fever and a generalized papular, vesicular rash that began on the head and neck. Within days, umbilicated lesions covered more than 50% of the child's body and he required mechanical ventilation.
After a course of antiviral and vasopressor medications, intravenous immunoglobulin, and supportive therapy, the child was discharged from the hospital—48 days after admission.
His mother, who had rested her head on the child's chest at one point, also developed a mild vesicular rash on her face.
Cell cultures in the home found evidence of the virus on a booster seat, a toy, and a slipper.
“This ain't real smallpox, people!” Dr. Lushniak said to emphasize the high level of transmission there would be in an actual attack, and the importance of then having a “ring” vaccination strategy aimed at everyone in contact with an exposed subject within 3–4 days.
Bioterrorism Prevention Steps
▸ Learn more by going to
▸ Join the civilian volunteer Medical Reserve Corps and participate in disaster response in your community (
▸ Train and deploy with a National Disaster Medical Assistance Team (
www.hhs.gov/aspr/opeo/ndms/teams/dmat.html
▸ Join the active reserve corps of the U.S. Public Health Service (
Source: Dr. Lushniak
SCOTTSDALE, ARIZ. — Despite the grateful lull that has followed Sept. 11 and the anthrax scare in 2001, bioterrorism remains a very real threat, according to a Food and Drug Administration counterterrorism official.
Dr. Boris Lushniak, the FDA's assistant commissioner for counterterrorism policy and assistant U.S. surgeon general, hopes that vigilance remains active in medical offices and emergency departments across the United States—but he has his doubts.
“I daresay we are going to be caught off guard,” Dr. Lushniak said during the Alfred L. Weiner Lecture at the annual meeting of the Noah Worcester Dermatological Society.
A disturbing number of organisms meet all or some of the criteria for an ideal agent of biological terrorism: easy to obtain and work with, inexpensive to produce, able to be widely disseminated, fairly stable in the environment, capable of producing high morbidity and mortality, transmissible from person to person, and difficult to diagnose and treat, which would allow an attack to quickly overwhelm the health care system.
On a positive note, the U.S. government has now stockpiled enough vaccine against smallpox to inoculate every man, woman, and child in the country, Dr. Lushniak reported.
On the other hand, when U.S. public health authorities were notified recently about an individual with suspicious skin lesions on an inbound flight from China, they were unable to find any hospital in a major metropolitan area willing to admit and quarantine the 200 people aboard until danger to the public was ruled out.
Fortunately, in that case, the threat was nullified during 4 hours of frantic planning as the airliner approached U.S. shores, but it stands as a wake-up call about preparedness. “We really have to change the way we do our business,” he said.
The potential agents of greatest concern—labeled category A by the Centers for Disease Control and Prevention—remain the same as ever: anthrax, smallpox, plague, tularemia, viral hemorrhagic fevers, and botulinum toxin.
“All suspicious or confirmed cases should be reported to health authorities immediately,” Dr. Lushniak said.
“We should all have that high level of suspicion. If you're worried, if you think it's part of your differential, you really should give someone a call. It may be a false alarm, may be overreading, but … really what we're looking for is someone to be able to ring that first fire alarm,” he said.
The timing could be critical.
Anthrax, for example, can be controlled with antibiotics if it is recognized and treated with postexposure prophylaxis before protein-rich toxins are produced by the organism. “If you can nip it in the spore bud, so to speak, then you really have solved the problem,” he said.
The disease is heralded by a flulike prodrome, progressing to hypoxia, dyspnea, and, often, mediastinal widening on x-ray.
He reminded dermatologists of the clinical presentation of cutaneous anthrax exposure following a 1- to 12-day incubation period. The presenting symptom might be tender pruritic macules that evolve into papules, which progress to vesicles and bullae formation in 24–48 hours. Bullae may rupture when they reach 1–2 cm. Eventually, telltale black necrotic ulcers may be seen, with a black eschar visible by day 6.
Differential diagnoses for cutaneous anthrax include brown recluse spider bites, ecthyma gangrenosum, tularemia, staph infections, and herpes labialis.
If smallpox is ever used in a bioterrorist attack, the tip-off may be its severe prodrome, which follows a noninfectious incubation period lasting 7–17 days, Dr. Lushniak said.
For 2–4 days, infected patients have very high fevers (101° F-104° F), prostration, myalgias, and malaise as small red macules and papules begin to form and even ulcerate on the tongue and mouth. An exanthem then appears in a centrifugal pattern on the face, arms, hands, legs, and feet. Macules form, then papules. By day 5, tense, often umbilicated vesicles can be seen that look like “BB pellets embedded in the skin,” he noted.
By day 6–12, pustules begin to form crusts that remain intact throughout a long period of infection until they separate at about day 28, leaving depressed scars.
Differential diagnoses include varicella, molluscum contagiosum, hand-foot-and-mouth disease, disseminated herpes simplex virus, herpes zoster, pustular drug eruptions, and scabies.
“If this were to come back into the world, the feeling is that at least the prodrome may keep people at home, in bed,” he said.
Even preventive efforts aimed at a potential bioterrorism attack have health implications that physicians should recognize, Dr. Lushniak said.
He described a 2007 case of household transmission of the live virus through a smallpox vaccine. Within a month of the father having received a smallpox vaccination prior to military deployment overseas, he came into contact with his infant son, who had eczema.
Although the father's vaccine site was covered during the unplanned visit, the child developed a high fever and a generalized papular, vesicular rash that began on the head and neck. Within days, umbilicated lesions covered more than 50% of the child's body and he required mechanical ventilation.
After a course of antiviral and vasopressor medications, intravenous immunoglobulin, and supportive therapy, the child was discharged from the hospital—48 days after admission.
His mother, who had rested her head on the child's chest at one point, also developed a mild vesicular rash on her face.
Cell cultures in the home found evidence of the virus on a booster seat, a toy, and a slipper.
“This ain't real smallpox, people!” Dr. Lushniak said to emphasize the high level of transmission there would be in an actual attack, and the importance of then having a “ring” vaccination strategy aimed at everyone in contact with an exposed subject within 3–4 days.
Bioterrorism Prevention Steps
▸ Learn more by going to
▸ Join the civilian volunteer Medical Reserve Corps and participate in disaster response in your community (
▸ Train and deploy with a National Disaster Medical Assistance Team (
www.hhs.gov/aspr/opeo/ndms/teams/dmat.html
▸ Join the active reserve corps of the U.S. Public Health Service (
Source: Dr. Lushniak
SCOTTSDALE, ARIZ. — Despite the grateful lull that has followed Sept. 11 and the anthrax scare in 2001, bioterrorism remains a very real threat, according to a Food and Drug Administration counterterrorism official.
Dr. Boris Lushniak, the FDA's assistant commissioner for counterterrorism policy and assistant U.S. surgeon general, hopes that vigilance remains active in medical offices and emergency departments across the United States—but he has his doubts.
“I daresay we are going to be caught off guard,” Dr. Lushniak said during the Alfred L. Weiner Lecture at the annual meeting of the Noah Worcester Dermatological Society.
A disturbing number of organisms meet all or some of the criteria for an ideal agent of biological terrorism: easy to obtain and work with, inexpensive to produce, able to be widely disseminated, fairly stable in the environment, capable of producing high morbidity and mortality, transmissible from person to person, and difficult to diagnose and treat, which would allow an attack to quickly overwhelm the health care system.
On a positive note, the U.S. government has now stockpiled enough vaccine against smallpox to inoculate every man, woman, and child in the country, Dr. Lushniak reported.
On the other hand, when U.S. public health authorities were notified recently about an individual with suspicious skin lesions on an inbound flight from China, they were unable to find any hospital in a major metropolitan area willing to admit and quarantine the 200 people aboard until danger to the public was ruled out.
Fortunately, in that case, the threat was nullified during 4 hours of frantic planning as the airliner approached U.S. shores, but it stands as a wake-up call about preparedness. “We really have to change the way we do our business,” he said.
The potential agents of greatest concern—labeled category A by the Centers for Disease Control and Prevention—remain the same as ever: anthrax, smallpox, plague, tularemia, viral hemorrhagic fevers, and botulinum toxin.
“All suspicious or confirmed cases should be reported to health authorities immediately,” Dr. Lushniak said.
“We should all have that high level of suspicion. If you're worried, if you think it's part of your differential, you really should give someone a call. It may be a false alarm, may be overreading, but … really what we're looking for is someone to be able to ring that first fire alarm,” he said.
The timing could be critical.
Anthrax, for example, can be controlled with antibiotics if it is recognized and treated with postexposure prophylaxis before protein-rich toxins are produced by the organism. “If you can nip it in the spore bud, so to speak, then you really have solved the problem,” he said.
The disease is heralded by a flulike prodrome, progressing to hypoxia, dyspnea, and, often, mediastinal widening on x-ray.
He reminded dermatologists of the clinical presentation of cutaneous anthrax exposure following a 1- to 12-day incubation period. The presenting symptom might be tender pruritic macules that evolve into papules, which progress to vesicles and bullae formation in 24–48 hours. Bullae may rupture when they reach 1–2 cm. Eventually, telltale black necrotic ulcers may be seen, with a black eschar visible by day 6.
Differential diagnoses for cutaneous anthrax include brown recluse spider bites, ecthyma gangrenosum, tularemia, staph infections, and herpes labialis.
If smallpox is ever used in a bioterrorist attack, the tip-off may be its severe prodrome, which follows a noninfectious incubation period lasting 7–17 days, Dr. Lushniak said.
For 2–4 days, infected patients have very high fevers (101° F-104° F), prostration, myalgias, and malaise as small red macules and papules begin to form and even ulcerate on the tongue and mouth. An exanthem then appears in a centrifugal pattern on the face, arms, hands, legs, and feet. Macules form, then papules. By day 5, tense, often umbilicated vesicles can be seen that look like “BB pellets embedded in the skin,” he noted.
By day 6–12, pustules begin to form crusts that remain intact throughout a long period of infection until they separate at about day 28, leaving depressed scars.
Differential diagnoses include varicella, molluscum contagiosum, hand-foot-and-mouth disease, disseminated herpes simplex virus, herpes zoster, pustular drug eruptions, and scabies.
“If this were to come back into the world, the feeling is that at least the prodrome may keep people at home, in bed,” he said.
Even preventive efforts aimed at a potential bioterrorism attack have health implications that physicians should recognize, Dr. Lushniak said.
He described a 2007 case of household transmission of the live virus through a smallpox vaccine. Within a month of the father having received a smallpox vaccination prior to military deployment overseas, he came into contact with his infant son, who had eczema.
Although the father's vaccine site was covered during the unplanned visit, the child developed a high fever and a generalized papular, vesicular rash that began on the head and neck. Within days, umbilicated lesions covered more than 50% of the child's body and he required mechanical ventilation.
After a course of antiviral and vasopressor medications, intravenous immunoglobulin, and supportive therapy, the child was discharged from the hospital—48 days after admission.
His mother, who had rested her head on the child's chest at one point, also developed a mild vesicular rash on her face.
Cell cultures in the home found evidence of the virus on a booster seat, a toy, and a slipper.
“This ain't real smallpox, people!” Dr. Lushniak said to emphasize the high level of transmission there would be in an actual attack, and the importance of then having a “ring” vaccination strategy aimed at everyone in contact with an exposed subject within 3–4 days.
Bioterrorism Prevention Steps
▸ Learn more by going to
▸ Join the civilian volunteer Medical Reserve Corps and participate in disaster response in your community (
▸ Train and deploy with a National Disaster Medical Assistance Team (
www.hhs.gov/aspr/opeo/ndms/teams/dmat.html
▸ Join the active reserve corps of the U.S. Public Health Service (
Source: Dr. Lushniak
PAs Bring 'Time Luxury' to Cosmetic Dermatology Practice
SANTA MONICA, CALIF. Without question, a physician assistant can inject welcome cash into a cosmetic dermatology practice, as evidenced by the $516,000 in income generated by Krystie P. Lennox in a recent 6-month period at an aesthetic center in Boca Raton, Fla.
Ms. Lennox believes, however, that the full measure of a PA's worth should be gauged in hours, not dollars. "One of the primary benefits to hiring a PA in aesthetic medicine is the luxury of time: taking an extra 5 minutes with patients to make the experience [different] from those clinicians who 'turn and burn' their patients," she said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation.
PAs can decrease waiting times, increase the number of services offered, and enhance patient safety by allowing for more follow-up visits. They can also bring to aesthetic medicine the art of "service, service, service," a business priority advocated by author Jack Mitchell in his book, "Hug Your Customers" (New York: Hyperion Press, 2003).
Paraphrasing the author, Ms. Lennox said, "It is no longer enough to satisfy customers. You have to develop extremely satisfied customers."
By positioning the PA as a highly trained professional with the time and desire to build a warm, personalized rapport with patients, a busy dermatologist may see dividends in terms of patient comfort and staff enthusiasm, she said.
PAs "must prove to patients that not only do they want to treat themselves to the botulinum toxin or dermal filler in this office, but also they want the PA to perform the treatment," said Ms. Lennox, a certified physician assistant who works with Dr. David Goldberg, a dermatologist, and Dr. Jason Pozner, a plastic surgeon, in Boca Raton. "The M.D. is critical in this handoff," she noted.
Team building begins with how the PA is introduced to the staff and how he or she is accepted and promoted by them. One helpful step in the process is to ensure that staff members receive cosmetic treatments from the PA, perhaps during live demonstrations, to enhance trust and rapport.
"A patient will speak with the receptionist on the phone and at the check-in counter, and likely will see the medical assistant and the physician before the first interaction. If any of those people hesitate in the slightest manner, the chance of patient conversion [to a PA cosmetic patient] drops dramatically," said Ms. Lennox.
The supervising physician should introduce established patients to the PA, and should voice confidence in his or her training and ability.
The introductory period may be an opportune time for a 15%-25% rise in physician fees for cosmetic services while the PA's charges remain at previous levels, thus offering patients an incentive to try the PA. This frees the physician to focus on techniques of special interest and difficult cases.
A physician assistant also can spend time at seminars, courses, and conferences, learning specialized and state-of-the-art cosmetic procedures for patients who want to stay on the cutting edge, Ms. Lennox said.
Admission to conferences is sometimes restricted to physicians; however, Ms. Lennox is one of the organizers of a meeting specially designed for PAs and nurse practitioners (www.aestheticextendersymposium.com
Currently, there are more than 68,000 PAs in clinical practice in the United States. They wrote more than 303 million prescriptions in 2007, approximately 17 million more than the year before.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
ELSEVIER GLOBAL MEDICAL NEWS
SANTA MONICA, CALIF. Without question, a physician assistant can inject welcome cash into a cosmetic dermatology practice, as evidenced by the $516,000 in income generated by Krystie P. Lennox in a recent 6-month period at an aesthetic center in Boca Raton, Fla.
Ms. Lennox believes, however, that the full measure of a PA's worth should be gauged in hours, not dollars. "One of the primary benefits to hiring a PA in aesthetic medicine is the luxury of time: taking an extra 5 minutes with patients to make the experience [different] from those clinicians who 'turn and burn' their patients," she said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation.
PAs can decrease waiting times, increase the number of services offered, and enhance patient safety by allowing for more follow-up visits. They can also bring to aesthetic medicine the art of "service, service, service," a business priority advocated by author Jack Mitchell in his book, "Hug Your Customers" (New York: Hyperion Press, 2003).
Paraphrasing the author, Ms. Lennox said, "It is no longer enough to satisfy customers. You have to develop extremely satisfied customers."
By positioning the PA as a highly trained professional with the time and desire to build a warm, personalized rapport with patients, a busy dermatologist may see dividends in terms of patient comfort and staff enthusiasm, she said.
PAs "must prove to patients that not only do they want to treat themselves to the botulinum toxin or dermal filler in this office, but also they want the PA to perform the treatment," said Ms. Lennox, a certified physician assistant who works with Dr. David Goldberg, a dermatologist, and Dr. Jason Pozner, a plastic surgeon, in Boca Raton. "The M.D. is critical in this handoff," she noted.
Team building begins with how the PA is introduced to the staff and how he or she is accepted and promoted by them. One helpful step in the process is to ensure that staff members receive cosmetic treatments from the PA, perhaps during live demonstrations, to enhance trust and rapport.
"A patient will speak with the receptionist on the phone and at the check-in counter, and likely will see the medical assistant and the physician before the first interaction. If any of those people hesitate in the slightest manner, the chance of patient conversion [to a PA cosmetic patient] drops dramatically," said Ms. Lennox.
The supervising physician should introduce established patients to the PA, and should voice confidence in his or her training and ability.
The introductory period may be an opportune time for a 15%-25% rise in physician fees for cosmetic services while the PA's charges remain at previous levels, thus offering patients an incentive to try the PA. This frees the physician to focus on techniques of special interest and difficult cases.
A physician assistant also can spend time at seminars, courses, and conferences, learning specialized and state-of-the-art cosmetic procedures for patients who want to stay on the cutting edge, Ms. Lennox said.
Admission to conferences is sometimes restricted to physicians; however, Ms. Lennox is one of the organizers of a meeting specially designed for PAs and nurse practitioners (www.aestheticextendersymposium.com
Currently, there are more than 68,000 PAs in clinical practice in the United States. They wrote more than 303 million prescriptions in 2007, approximately 17 million more than the year before.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
ELSEVIER GLOBAL MEDICAL NEWS
SANTA MONICA, CALIF. Without question, a physician assistant can inject welcome cash into a cosmetic dermatology practice, as evidenced by the $516,000 in income generated by Krystie P. Lennox in a recent 6-month period at an aesthetic center in Boca Raton, Fla.
Ms. Lennox believes, however, that the full measure of a PA's worth should be gauged in hours, not dollars. "One of the primary benefits to hiring a PA in aesthetic medicine is the luxury of time: taking an extra 5 minutes with patients to make the experience [different] from those clinicians who 'turn and burn' their patients," she said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation.
PAs can decrease waiting times, increase the number of services offered, and enhance patient safety by allowing for more follow-up visits. They can also bring to aesthetic medicine the art of "service, service, service," a business priority advocated by author Jack Mitchell in his book, "Hug Your Customers" (New York: Hyperion Press, 2003).
Paraphrasing the author, Ms. Lennox said, "It is no longer enough to satisfy customers. You have to develop extremely satisfied customers."
By positioning the PA as a highly trained professional with the time and desire to build a warm, personalized rapport with patients, a busy dermatologist may see dividends in terms of patient comfort and staff enthusiasm, she said.
PAs "must prove to patients that not only do they want to treat themselves to the botulinum toxin or dermal filler in this office, but also they want the PA to perform the treatment," said Ms. Lennox, a certified physician assistant who works with Dr. David Goldberg, a dermatologist, and Dr. Jason Pozner, a plastic surgeon, in Boca Raton. "The M.D. is critical in this handoff," she noted.
Team building begins with how the PA is introduced to the staff and how he or she is accepted and promoted by them. One helpful step in the process is to ensure that staff members receive cosmetic treatments from the PA, perhaps during live demonstrations, to enhance trust and rapport.
"A patient will speak with the receptionist on the phone and at the check-in counter, and likely will see the medical assistant and the physician before the first interaction. If any of those people hesitate in the slightest manner, the chance of patient conversion [to a PA cosmetic patient] drops dramatically," said Ms. Lennox.
The supervising physician should introduce established patients to the PA, and should voice confidence in his or her training and ability.
The introductory period may be an opportune time for a 15%-25% rise in physician fees for cosmetic services while the PA's charges remain at previous levels, thus offering patients an incentive to try the PA. This frees the physician to focus on techniques of special interest and difficult cases.
A physician assistant also can spend time at seminars, courses, and conferences, learning specialized and state-of-the-art cosmetic procedures for patients who want to stay on the cutting edge, Ms. Lennox said.
Admission to conferences is sometimes restricted to physicians; however, Ms. Lennox is one of the organizers of a meeting specially designed for PAs and nurse practitioners (www.aestheticextendersymposium.com
Currently, there are more than 68,000 PAs in clinical practice in the United States. They wrote more than 303 million prescriptions in 2007, approximately 17 million more than the year before.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
ELSEVIER GLOBAL MEDICAL NEWS
Medical Spa Inhouse Marketing Lures 6,000 New Patients a Year
SANTA MONICA, CALIF. Don't bother leafing through the pages of glossy, upscale San Diego magazines to find advertisements for Dr. Mitchel P. Goldman's successful, 6-year-old medical spa.
Magazine marketing recruits mostly "looky-loos," said Dr. Goldman at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation.
Most of the marketing for La Jolla (Calif.) Spa MD occurs only after a patient enters the column-framed, wood-and-glass doors and is greeted by one of 92 staff members for a dermatology, cosmetic surgery, or cosmetic dentistry procedure; wellness/longevity consultation; spa service, or a trip to the retail center.
Then, "it's all marketing," from the videos playing in the waiting room and the artfully displayed brochures to the up-close (and sometimes alarming) computer analysis of patients' faces and flaws, with a scorecard and list of recommended procedures.
The patient who arrives for a simple $150 massagethe least profitable service in the spamight also be informed that a cancellation has left a Botox appointment available, for 10% off.
Spa aestheticians, massage therapists, and make-up specialists receive incentives when their clients sign up for cosmetic medical procedures.
Established patients, whose names go into the computer database, receive discount coupons, specials, and gift cards. Birthday and anniversary cards arrive each year, with $50-off coupons. The spa newsletter features special promotions.
Upward of 10,000 Web site visitors a month, often drawn to the site by word-of-mouth, learn about spa and medical services, schedule spa "packages"(the 3-hour, four-treatment "anti-cellulite sampler" goes for $620), and purchase products once they establish an online account, thus entering the database to receive e-mail blast offers for discount services.
Although he is not big on print and broadcast advertising, Dr. Goldman said he is generous with his time for interviews with journalists. He also promotes the spa by making generous charitable donations. At any given time, the practice may be conducting 20 active clinical trials, any of which may draw a newcomer who will then return as a paying customer.
Dr. Goldman's unconventional, upscale marketing efforts seem to be paying off. In the past 3 years, the number of new patients rose from 5,600 to 5,700, to 6,000, respectively, he said.
SDEF and this newspaper are wholly owned subsidiaries of Elsevier.
Dr. Mitchel P. Goldman's upscale marketing efforts are paying off. ©Marty Mann
What's Hot and What's Not at An Upscale California MediSpa
Dr. Goldman, founder of the La Jolla Spa MD medical spa, recently shared his observations about which treatments are "in," which are "out," and which aren't worth the trouble.
Ubiquitous Botox procedures, always a draw, and requests for other facial fillers have been up 25% in recent months at his spa, as a down economy induces penny-pinching socialites to seek out temporary, relatively affordable alternatives to big-ticket cosmetic surgery procedures, according to Dr. Goldman.
As a whole, aesthetic surgery procedures declined 10% last year, while appointments for plastic surgery took a 50% dive, said Dr. Goldman. Adding that breast implants, facelifts, and blepharoplasty procedures have seen a decline "all over California."
He predicted the popularity of these procedures will rebound with "pent-up demand" once the economy improves.
Leg vein procedures, hair removal, photodynamic therapy for acne, and intense pulsed light treatments are all holding their own, and cosmetic dentistry has proved to be "very profitable," he said.
The spa's retail center, which features a variety of skin products, has shown 133% growth in 5 years, now generating $1.5 million/year in sales.
Dr. Goldman doesn't recommend catering to patients requesting laser tattoo removal.
"They're the worst patients in the world," who may have paid $100 while drunk to get a tattoo and are irritated at the notion of paying thousands for 5-50 treatments to have them removed, he said.
SANTA MONICA, CALIF. Don't bother leafing through the pages of glossy, upscale San Diego magazines to find advertisements for Dr. Mitchel P. Goldman's successful, 6-year-old medical spa.
Magazine marketing recruits mostly "looky-loos," said Dr. Goldman at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation.
Most of the marketing for La Jolla (Calif.) Spa MD occurs only after a patient enters the column-framed, wood-and-glass doors and is greeted by one of 92 staff members for a dermatology, cosmetic surgery, or cosmetic dentistry procedure; wellness/longevity consultation; spa service, or a trip to the retail center.
Then, "it's all marketing," from the videos playing in the waiting room and the artfully displayed brochures to the up-close (and sometimes alarming) computer analysis of patients' faces and flaws, with a scorecard and list of recommended procedures.
The patient who arrives for a simple $150 massagethe least profitable service in the spamight also be informed that a cancellation has left a Botox appointment available, for 10% off.
Spa aestheticians, massage therapists, and make-up specialists receive incentives when their clients sign up for cosmetic medical procedures.
Established patients, whose names go into the computer database, receive discount coupons, specials, and gift cards. Birthday and anniversary cards arrive each year, with $50-off coupons. The spa newsletter features special promotions.
Upward of 10,000 Web site visitors a month, often drawn to the site by word-of-mouth, learn about spa and medical services, schedule spa "packages"(the 3-hour, four-treatment "anti-cellulite sampler" goes for $620), and purchase products once they establish an online account, thus entering the database to receive e-mail blast offers for discount services.
Although he is not big on print and broadcast advertising, Dr. Goldman said he is generous with his time for interviews with journalists. He also promotes the spa by making generous charitable donations. At any given time, the practice may be conducting 20 active clinical trials, any of which may draw a newcomer who will then return as a paying customer.
Dr. Goldman's unconventional, upscale marketing efforts seem to be paying off. In the past 3 years, the number of new patients rose from 5,600 to 5,700, to 6,000, respectively, he said.
SDEF and this newspaper are wholly owned subsidiaries of Elsevier.
Dr. Mitchel P. Goldman's upscale marketing efforts are paying off. ©Marty Mann
What's Hot and What's Not at An Upscale California MediSpa
Dr. Goldman, founder of the La Jolla Spa MD medical spa, recently shared his observations about which treatments are "in," which are "out," and which aren't worth the trouble.
Ubiquitous Botox procedures, always a draw, and requests for other facial fillers have been up 25% in recent months at his spa, as a down economy induces penny-pinching socialites to seek out temporary, relatively affordable alternatives to big-ticket cosmetic surgery procedures, according to Dr. Goldman.
As a whole, aesthetic surgery procedures declined 10% last year, while appointments for plastic surgery took a 50% dive, said Dr. Goldman. Adding that breast implants, facelifts, and blepharoplasty procedures have seen a decline "all over California."
He predicted the popularity of these procedures will rebound with "pent-up demand" once the economy improves.
Leg vein procedures, hair removal, photodynamic therapy for acne, and intense pulsed light treatments are all holding their own, and cosmetic dentistry has proved to be "very profitable," he said.
The spa's retail center, which features a variety of skin products, has shown 133% growth in 5 years, now generating $1.5 million/year in sales.
Dr. Goldman doesn't recommend catering to patients requesting laser tattoo removal.
"They're the worst patients in the world," who may have paid $100 while drunk to get a tattoo and are irritated at the notion of paying thousands for 5-50 treatments to have them removed, he said.
SANTA MONICA, CALIF. Don't bother leafing through the pages of glossy, upscale San Diego magazines to find advertisements for Dr. Mitchel P. Goldman's successful, 6-year-old medical spa.
Magazine marketing recruits mostly "looky-loos," said Dr. Goldman at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation.
Most of the marketing for La Jolla (Calif.) Spa MD occurs only after a patient enters the column-framed, wood-and-glass doors and is greeted by one of 92 staff members for a dermatology, cosmetic surgery, or cosmetic dentistry procedure; wellness/longevity consultation; spa service, or a trip to the retail center.
Then, "it's all marketing," from the videos playing in the waiting room and the artfully displayed brochures to the up-close (and sometimes alarming) computer analysis of patients' faces and flaws, with a scorecard and list of recommended procedures.
The patient who arrives for a simple $150 massagethe least profitable service in the spamight also be informed that a cancellation has left a Botox appointment available, for 10% off.
Spa aestheticians, massage therapists, and make-up specialists receive incentives when their clients sign up for cosmetic medical procedures.
Established patients, whose names go into the computer database, receive discount coupons, specials, and gift cards. Birthday and anniversary cards arrive each year, with $50-off coupons. The spa newsletter features special promotions.
Upward of 10,000 Web site visitors a month, often drawn to the site by word-of-mouth, learn about spa and medical services, schedule spa "packages"(the 3-hour, four-treatment "anti-cellulite sampler" goes for $620), and purchase products once they establish an online account, thus entering the database to receive e-mail blast offers for discount services.
Although he is not big on print and broadcast advertising, Dr. Goldman said he is generous with his time for interviews with journalists. He also promotes the spa by making generous charitable donations. At any given time, the practice may be conducting 20 active clinical trials, any of which may draw a newcomer who will then return as a paying customer.
Dr. Goldman's unconventional, upscale marketing efforts seem to be paying off. In the past 3 years, the number of new patients rose from 5,600 to 5,700, to 6,000, respectively, he said.
SDEF and this newspaper are wholly owned subsidiaries of Elsevier.
Dr. Mitchel P. Goldman's upscale marketing efforts are paying off. ©Marty Mann
What's Hot and What's Not at An Upscale California MediSpa
Dr. Goldman, founder of the La Jolla Spa MD medical spa, recently shared his observations about which treatments are "in," which are "out," and which aren't worth the trouble.
Ubiquitous Botox procedures, always a draw, and requests for other facial fillers have been up 25% in recent months at his spa, as a down economy induces penny-pinching socialites to seek out temporary, relatively affordable alternatives to big-ticket cosmetic surgery procedures, according to Dr. Goldman.
As a whole, aesthetic surgery procedures declined 10% last year, while appointments for plastic surgery took a 50% dive, said Dr. Goldman. Adding that breast implants, facelifts, and blepharoplasty procedures have seen a decline "all over California."
He predicted the popularity of these procedures will rebound with "pent-up demand" once the economy improves.
Leg vein procedures, hair removal, photodynamic therapy for acne, and intense pulsed light treatments are all holding their own, and cosmetic dentistry has proved to be "very profitable," he said.
The spa's retail center, which features a variety of skin products, has shown 133% growth in 5 years, now generating $1.5 million/year in sales.
Dr. Goldman doesn't recommend catering to patients requesting laser tattoo removal.
"They're the worst patients in the world," who may have paid $100 while drunk to get a tattoo and are irritated at the notion of paying thousands for 5-50 treatments to have them removed, he said.
States Eye 'Luxury' Aesthetic Procedure Taxes, Restrictions
SANTA MONICA, CALIF. When state coffers get low, legislators go hunting for cash.
Lately, in states such as Maryland and New York, lawmakers have been considering taxes on "luxury" items from upscale cars to aesthetic surgery offices, Dr. Ron Wheeland said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation.
"This is not a new idea," he said, citing longstanding sales taxes on cosmetic surgery procedures in New Jersey and Minnesota.
In New Jersey, in fact, a Senate bill seeks to repeal the 2004 sales tax on cosmetic procedures because it generated far less money than expected.
But that experience hasn't stopped other states from trying.
In Tennessee, it's the same tune with different lyrics, as legislators consider a tax on devices and equipment used in cosmetic procedures, rather than targeting the consumers who pay for laser procedures and facelifts, he said.
Aesthetic procedures are also in the legislative spotlight with regard to safety and oversight, Dr. Wheeland said during a talk on the "new truths" in dermatology.
Restricting procedures and imposing tighter oversight measures are seen as "white hat" moves for legislators, who like to be seen protecting constituents, even in cases when not all the facts are in, said Dr. Wheeland, director of dermatologic surgery at the University of Missouri-Columbia.
In Virginia, House Bill 1399 would establish as a professional entity "laser light technicians" who would report not to the state boards that oversee physicians or nurses but to the board that oversees barbers and cosmetologists.
"I can only hope that that bill is defeated," he said.
In Georgia, Illinois, and California, proposed legislation would require preoperative examinations prior to laser or cosmetic surgical procedures. In Arizona, a bill is being considered that would allow nonphysicians to perform aesthetic procedures with lasers or light devices without physician supervision if they pass a 40-hour course.
Another bill in Illinois, which was referred to the rules committee in April, would permit only board-certified plastic surgeons to inject Botox, perform chemical peels, or perform aesthetic laser procedures.
"This one bothers me the most," said Dr. Wheeland. "When you think of these three procedures in particular, the first thing that ought to pop into your mind is that all three were developed by dermatologists."
It behooves dermatologists to be alert to themes and patterns in legislative proposals and to become involved when their own states are considering laws that would have a direct impact on the practice of dermatology, Dr. Wheeland said.
SDEF and this publication are wholly owned subsidiaries of Elsevier.
SANTA MONICA, CALIF. When state coffers get low, legislators go hunting for cash.
Lately, in states such as Maryland and New York, lawmakers have been considering taxes on "luxury" items from upscale cars to aesthetic surgery offices, Dr. Ron Wheeland said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation.
"This is not a new idea," he said, citing longstanding sales taxes on cosmetic surgery procedures in New Jersey and Minnesota.
In New Jersey, in fact, a Senate bill seeks to repeal the 2004 sales tax on cosmetic procedures because it generated far less money than expected.
But that experience hasn't stopped other states from trying.
In Tennessee, it's the same tune with different lyrics, as legislators consider a tax on devices and equipment used in cosmetic procedures, rather than targeting the consumers who pay for laser procedures and facelifts, he said.
Aesthetic procedures are also in the legislative spotlight with regard to safety and oversight, Dr. Wheeland said during a talk on the "new truths" in dermatology.
Restricting procedures and imposing tighter oversight measures are seen as "white hat" moves for legislators, who like to be seen protecting constituents, even in cases when not all the facts are in, said Dr. Wheeland, director of dermatologic surgery at the University of Missouri-Columbia.
In Virginia, House Bill 1399 would establish as a professional entity "laser light technicians" who would report not to the state boards that oversee physicians or nurses but to the board that oversees barbers and cosmetologists.
"I can only hope that that bill is defeated," he said.
In Georgia, Illinois, and California, proposed legislation would require preoperative examinations prior to laser or cosmetic surgical procedures. In Arizona, a bill is being considered that would allow nonphysicians to perform aesthetic procedures with lasers or light devices without physician supervision if they pass a 40-hour course.
Another bill in Illinois, which was referred to the rules committee in April, would permit only board-certified plastic surgeons to inject Botox, perform chemical peels, or perform aesthetic laser procedures.
"This one bothers me the most," said Dr. Wheeland. "When you think of these three procedures in particular, the first thing that ought to pop into your mind is that all three were developed by dermatologists."
It behooves dermatologists to be alert to themes and patterns in legislative proposals and to become involved when their own states are considering laws that would have a direct impact on the practice of dermatology, Dr. Wheeland said.
SDEF and this publication are wholly owned subsidiaries of Elsevier.
SANTA MONICA, CALIF. When state coffers get low, legislators go hunting for cash.
Lately, in states such as Maryland and New York, lawmakers have been considering taxes on "luxury" items from upscale cars to aesthetic surgery offices, Dr. Ron Wheeland said at a cosmetic dermatology seminar sponsored by Skin Disease Education Foundation.
"This is not a new idea," he said, citing longstanding sales taxes on cosmetic surgery procedures in New Jersey and Minnesota.
In New Jersey, in fact, a Senate bill seeks to repeal the 2004 sales tax on cosmetic procedures because it generated far less money than expected.
But that experience hasn't stopped other states from trying.
In Tennessee, it's the same tune with different lyrics, as legislators consider a tax on devices and equipment used in cosmetic procedures, rather than targeting the consumers who pay for laser procedures and facelifts, he said.
Aesthetic procedures are also in the legislative spotlight with regard to safety and oversight, Dr. Wheeland said during a talk on the "new truths" in dermatology.
Restricting procedures and imposing tighter oversight measures are seen as "white hat" moves for legislators, who like to be seen protecting constituents, even in cases when not all the facts are in, said Dr. Wheeland, director of dermatologic surgery at the University of Missouri-Columbia.
In Virginia, House Bill 1399 would establish as a professional entity "laser light technicians" who would report not to the state boards that oversee physicians or nurses but to the board that oversees barbers and cosmetologists.
"I can only hope that that bill is defeated," he said.
In Georgia, Illinois, and California, proposed legislation would require preoperative examinations prior to laser or cosmetic surgical procedures. In Arizona, a bill is being considered that would allow nonphysicians to perform aesthetic procedures with lasers or light devices without physician supervision if they pass a 40-hour course.
Another bill in Illinois, which was referred to the rules committee in April, would permit only board-certified plastic surgeons to inject Botox, perform chemical peels, or perform aesthetic laser procedures.
"This one bothers me the most," said Dr. Wheeland. "When you think of these three procedures in particular, the first thing that ought to pop into your mind is that all three were developed by dermatologists."
It behooves dermatologists to be alert to themes and patterns in legislative proposals and to become involved when their own states are considering laws that would have a direct impact on the practice of dermatology, Dr. Wheeland said.
SDEF and this publication are wholly owned subsidiaries of Elsevier.
Fractional Technology Brings New Life to CO2 Laser
SANTA MONICA, CALIF. In the world of cosmetic skin rejuvenation, what's old is new again.
Ablative laser resurfacing with CO2 lasersusing fractionalized laser energy this time around to reduce healing timedominated a recent cosmetic dermatology seminar sponsored by Skin Disease Educational Foundation.
"It's almost like we're rediscovering the wheel," said Dr. Mitchel Goldman, who is a dermatologist in private practice in La Jolla, Calif.
Dr. Goldman explained that he has 32 lasers in his office, but the only ones that truly smooth wrinkles and tighten the skin are the CO2 and erbium:YAG lasers.
The others, he said, mainly address pigmentation issues and vascular changes. They demand multiple visits, multiple passes, and generate multiple complaints from patients who see little improvement in their overall appearance.
The drawback with CO2 lasers is the downtime to allow for healing, even with fractional ablative resurfacing. "No matter what anyone says, there is some downtime," now averaging approximately 4-5 days, compared with the 1-4 weeks for first-generation CO2 lasers, he said.
The lure of fractional CO2 resurfacing is its reliability in producing meaningful cosmetic skin changes with less damage by creating pinpoint "drill holes" linked by tissue bridges.
Among 356 patients who have undergone fractionalized CO2 laser procedures in his practice in the past 3 years, "we have seen virtually no complications," he said. A 1% incidence of herpes was eliminated by the addition of antiviral prophylaxis in every case. There has been a 2% rate of erythema lasting for more than 4 days.
"That was it," he said, detailing his experience with Lumenis systems.
The three big players in ablative fractional resurfacing, according to Dr. Goldman, are the Fraxel Re:pair by Reliant, and the ActiveFX and DeepFX by Lumenis.
Speakers discussed their experiences with each, coming to the conclusion that the devices induce significant nonspecific thermal damage that induces collagen remodeling, yet invite far fewer complications than traditional CO2 lasers, including burns and pigmentation abnormalities.
"I think there's been a quantum shift back toward CO2. The reason is, CO2 works," said Dr. John Fezza of Sarasota, Fla.
"There's no question, there is some redness," acknowledged Dr. Fezza, who performed a real-time video laser resurfacing procedure on a 42-year-old woman with sun damage during the meeting.
Still, in more than 2 years, he has seen no lasting hyper- or hypopigmentationcommon side effects associated with traditional CO2 laser resurfacing.
Patients with realistic expectations know that if they have a fractionated CO2 laser procedure on a Friday, they'll be ready to go out with makeup by Monday.
"They don't mind house arrest for 3 days," he said.
Dr. Goldman said he considers fractionated CO2 lasers "safe if you go within the [recommended] parameters," but they require care and caution just like their prototypes.
Dr. Christopher Zachary, professor and chair of dermatology at the University of California, Irvine, said he believes the reason fractionated CO2 lasers have a measurable impact on wrinkling and skin tightening is that "they have the ability to induce a defect that is deeper than it is wide."
Dr. David Goldberg agreed. For photo damage and superficial rhytids, the key is density, but depth is what matters if the goal is skin tightening, he said.
"I'm pretty convinced," Dr. Goldberg said.
All speakers at the session disclosed grant support, laser equipment loans, and/or speakers bureau ties to companies that manufacture lasers, including Reliant and Lumenis.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
SANTA MONICA, CALIF. In the world of cosmetic skin rejuvenation, what's old is new again.
Ablative laser resurfacing with CO2 lasersusing fractionalized laser energy this time around to reduce healing timedominated a recent cosmetic dermatology seminar sponsored by Skin Disease Educational Foundation.
"It's almost like we're rediscovering the wheel," said Dr. Mitchel Goldman, who is a dermatologist in private practice in La Jolla, Calif.
Dr. Goldman explained that he has 32 lasers in his office, but the only ones that truly smooth wrinkles and tighten the skin are the CO2 and erbium:YAG lasers.
The others, he said, mainly address pigmentation issues and vascular changes. They demand multiple visits, multiple passes, and generate multiple complaints from patients who see little improvement in their overall appearance.
The drawback with CO2 lasers is the downtime to allow for healing, even with fractional ablative resurfacing. "No matter what anyone says, there is some downtime," now averaging approximately 4-5 days, compared with the 1-4 weeks for first-generation CO2 lasers, he said.
The lure of fractional CO2 resurfacing is its reliability in producing meaningful cosmetic skin changes with less damage by creating pinpoint "drill holes" linked by tissue bridges.
Among 356 patients who have undergone fractionalized CO2 laser procedures in his practice in the past 3 years, "we have seen virtually no complications," he said. A 1% incidence of herpes was eliminated by the addition of antiviral prophylaxis in every case. There has been a 2% rate of erythema lasting for more than 4 days.
"That was it," he said, detailing his experience with Lumenis systems.
The three big players in ablative fractional resurfacing, according to Dr. Goldman, are the Fraxel Re:pair by Reliant, and the ActiveFX and DeepFX by Lumenis.
Speakers discussed their experiences with each, coming to the conclusion that the devices induce significant nonspecific thermal damage that induces collagen remodeling, yet invite far fewer complications than traditional CO2 lasers, including burns and pigmentation abnormalities.
"I think there's been a quantum shift back toward CO2. The reason is, CO2 works," said Dr. John Fezza of Sarasota, Fla.
"There's no question, there is some redness," acknowledged Dr. Fezza, who performed a real-time video laser resurfacing procedure on a 42-year-old woman with sun damage during the meeting.
Still, in more than 2 years, he has seen no lasting hyper- or hypopigmentationcommon side effects associated with traditional CO2 laser resurfacing.
Patients with realistic expectations know that if they have a fractionated CO2 laser procedure on a Friday, they'll be ready to go out with makeup by Monday.
"They don't mind house arrest for 3 days," he said.
Dr. Goldman said he considers fractionated CO2 lasers "safe if you go within the [recommended] parameters," but they require care and caution just like their prototypes.
Dr. Christopher Zachary, professor and chair of dermatology at the University of California, Irvine, said he believes the reason fractionated CO2 lasers have a measurable impact on wrinkling and skin tightening is that "they have the ability to induce a defect that is deeper than it is wide."
Dr. David Goldberg agreed. For photo damage and superficial rhytids, the key is density, but depth is what matters if the goal is skin tightening, he said.
"I'm pretty convinced," Dr. Goldberg said.
All speakers at the session disclosed grant support, laser equipment loans, and/or speakers bureau ties to companies that manufacture lasers, including Reliant and Lumenis.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
SANTA MONICA, CALIF. In the world of cosmetic skin rejuvenation, what's old is new again.
Ablative laser resurfacing with CO2 lasersusing fractionalized laser energy this time around to reduce healing timedominated a recent cosmetic dermatology seminar sponsored by Skin Disease Educational Foundation.
"It's almost like we're rediscovering the wheel," said Dr. Mitchel Goldman, who is a dermatologist in private practice in La Jolla, Calif.
Dr. Goldman explained that he has 32 lasers in his office, but the only ones that truly smooth wrinkles and tighten the skin are the CO2 and erbium:YAG lasers.
The others, he said, mainly address pigmentation issues and vascular changes. They demand multiple visits, multiple passes, and generate multiple complaints from patients who see little improvement in their overall appearance.
The drawback with CO2 lasers is the downtime to allow for healing, even with fractional ablative resurfacing. "No matter what anyone says, there is some downtime," now averaging approximately 4-5 days, compared with the 1-4 weeks for first-generation CO2 lasers, he said.
The lure of fractional CO2 resurfacing is its reliability in producing meaningful cosmetic skin changes with less damage by creating pinpoint "drill holes" linked by tissue bridges.
Among 356 patients who have undergone fractionalized CO2 laser procedures in his practice in the past 3 years, "we have seen virtually no complications," he said. A 1% incidence of herpes was eliminated by the addition of antiviral prophylaxis in every case. There has been a 2% rate of erythema lasting for more than 4 days.
"That was it," he said, detailing his experience with Lumenis systems.
The three big players in ablative fractional resurfacing, according to Dr. Goldman, are the Fraxel Re:pair by Reliant, and the ActiveFX and DeepFX by Lumenis.
Speakers discussed their experiences with each, coming to the conclusion that the devices induce significant nonspecific thermal damage that induces collagen remodeling, yet invite far fewer complications than traditional CO2 lasers, including burns and pigmentation abnormalities.
"I think there's been a quantum shift back toward CO2. The reason is, CO2 works," said Dr. John Fezza of Sarasota, Fla.
"There's no question, there is some redness," acknowledged Dr. Fezza, who performed a real-time video laser resurfacing procedure on a 42-year-old woman with sun damage during the meeting.
Still, in more than 2 years, he has seen no lasting hyper- or hypopigmentationcommon side effects associated with traditional CO2 laser resurfacing.
Patients with realistic expectations know that if they have a fractionated CO2 laser procedure on a Friday, they'll be ready to go out with makeup by Monday.
"They don't mind house arrest for 3 days," he said.
Dr. Goldman said he considers fractionated CO2 lasers "safe if you go within the [recommended] parameters," but they require care and caution just like their prototypes.
Dr. Christopher Zachary, professor and chair of dermatology at the University of California, Irvine, said he believes the reason fractionated CO2 lasers have a measurable impact on wrinkling and skin tightening is that "they have the ability to induce a defect that is deeper than it is wide."
Dr. David Goldberg agreed. For photo damage and superficial rhytids, the key is density, but depth is what matters if the goal is skin tightening, he said.
"I'm pretty convinced," Dr. Goldberg said.
All speakers at the session disclosed grant support, laser equipment loans, and/or speakers bureau ties to companies that manufacture lasers, including Reliant and Lumenis.
SDEF and this news organization are wholly owned subsidiaries of Elsevier.
Primary Care Counseling Failed To Curb Childhood Overweight
HONOLULU — A large, expensive, randomized trial of intensive primary care counseling failed to have any measurable effect on reducing weight gain in children who were already overweight.
The disappointing results of the 12-month Australian LEAP2 (Live, Eat, and Play) study may have wide-ranging policy implications for governments seeking to avert long-term health costs associated with childhood obesity in developed countries, said Dr. Melissa Wake, director of research and public health at the Centre for Community Child Health in Melbourne.
Despite proving that primary care providers could be trained to deliver brief, comprehensive, family-based, solution-focused therapy, with encouragingly high participation rates, “this intervention, at least, did not have any impact on any primary or secondary outcomes,” Dr. Wake reported in an oral presentation at the annual meeting of the Pediatric Academic Societies. “It was both costly and ineffective.”
Among 3,958 children aged 5–12 years who were screened by primary care providers in Melbourne, 947 (24%) were found to be overweight or mildly obese, and were therefore eligible for a 4-session, 12-week intervention during which the provider individually counseled the family in nutrition, physical activity, and sedentary behavior.
A lengthy initial session was aimed at assessing goals and willingness to change, followed by structured consultations. Extensive materials and accelerometers also were provided to each family.
To learn the techniques, 66 general physicians from 45 practices representing a broad socioeconomic range of families attended two 2.5-hour educational sessions that involved interactive DVD sessions and participated with a trained actor in two simulated family consultations.
Ultimately 258 families were enrolled, 139 assigned to the interventional arm and 119 to the control group, which was provided materials and four physician consultations over 3 months.
Impressive advances were seen in physicians' comfort levels and competency in managing childhood obesity, said Dr. Wake.
At least one consultation session was attended by 96% of families. The mean number of sessions attended was 3, with a range of 1–4. Twelve-month follow-up BMI was available for 94% of children enrolled.
Despite this extraordinary level of participation, the results were dismal, with no statistical change seen at 12 months in the children's or parents' BMI, physical activity, nutrition, or body satisfaction/dissatisfaction.
One child in the intervention group actually gained 10 kg, more than 22 pounds, over the year of the study. The only improvement at 12 months was an increase in psychosocial measures among children participating in the intervention group on the Pediatric Quality of Life: 77.7 on a 100-point scale, compared with 74.4 for children assigned to the control group.
The cost per child was over $1,000, although Dr. Wake noted that the individual cost could be reduced to perhaps $412 if trained physicians were each seeing many children.
Nonetheless, if the program were to be extended to the 250,000 overweight and obese children in Australia the cost would be over $100 million.
Dr. Wake quoted Sir Winston Churchill, who said, “No matter how beautiful the strategy, one occasionally has to look at the results.” In this study, the results didn't justify the costs, with potentially important lessons to be learned for policy bodies in Australia, the United States, and the United Kingdom, all of whom are considering brief primary care interventions in an effort to reduce childhood obesity, she said.
HONOLULU — A large, expensive, randomized trial of intensive primary care counseling failed to have any measurable effect on reducing weight gain in children who were already overweight.
The disappointing results of the 12-month Australian LEAP2 (Live, Eat, and Play) study may have wide-ranging policy implications for governments seeking to avert long-term health costs associated with childhood obesity in developed countries, said Dr. Melissa Wake, director of research and public health at the Centre for Community Child Health in Melbourne.
Despite proving that primary care providers could be trained to deliver brief, comprehensive, family-based, solution-focused therapy, with encouragingly high participation rates, “this intervention, at least, did not have any impact on any primary or secondary outcomes,” Dr. Wake reported in an oral presentation at the annual meeting of the Pediatric Academic Societies. “It was both costly and ineffective.”
Among 3,958 children aged 5–12 years who were screened by primary care providers in Melbourne, 947 (24%) were found to be overweight or mildly obese, and were therefore eligible for a 4-session, 12-week intervention during which the provider individually counseled the family in nutrition, physical activity, and sedentary behavior.
A lengthy initial session was aimed at assessing goals and willingness to change, followed by structured consultations. Extensive materials and accelerometers also were provided to each family.
To learn the techniques, 66 general physicians from 45 practices representing a broad socioeconomic range of families attended two 2.5-hour educational sessions that involved interactive DVD sessions and participated with a trained actor in two simulated family consultations.
Ultimately 258 families were enrolled, 139 assigned to the interventional arm and 119 to the control group, which was provided materials and four physician consultations over 3 months.
Impressive advances were seen in physicians' comfort levels and competency in managing childhood obesity, said Dr. Wake.
At least one consultation session was attended by 96% of families. The mean number of sessions attended was 3, with a range of 1–4. Twelve-month follow-up BMI was available for 94% of children enrolled.
Despite this extraordinary level of participation, the results were dismal, with no statistical change seen at 12 months in the children's or parents' BMI, physical activity, nutrition, or body satisfaction/dissatisfaction.
One child in the intervention group actually gained 10 kg, more than 22 pounds, over the year of the study. The only improvement at 12 months was an increase in psychosocial measures among children participating in the intervention group on the Pediatric Quality of Life: 77.7 on a 100-point scale, compared with 74.4 for children assigned to the control group.
The cost per child was over $1,000, although Dr. Wake noted that the individual cost could be reduced to perhaps $412 if trained physicians were each seeing many children.
Nonetheless, if the program were to be extended to the 250,000 overweight and obese children in Australia the cost would be over $100 million.
Dr. Wake quoted Sir Winston Churchill, who said, “No matter how beautiful the strategy, one occasionally has to look at the results.” In this study, the results didn't justify the costs, with potentially important lessons to be learned for policy bodies in Australia, the United States, and the United Kingdom, all of whom are considering brief primary care interventions in an effort to reduce childhood obesity, she said.
HONOLULU — A large, expensive, randomized trial of intensive primary care counseling failed to have any measurable effect on reducing weight gain in children who were already overweight.
The disappointing results of the 12-month Australian LEAP2 (Live, Eat, and Play) study may have wide-ranging policy implications for governments seeking to avert long-term health costs associated with childhood obesity in developed countries, said Dr. Melissa Wake, director of research and public health at the Centre for Community Child Health in Melbourne.
Despite proving that primary care providers could be trained to deliver brief, comprehensive, family-based, solution-focused therapy, with encouragingly high participation rates, “this intervention, at least, did not have any impact on any primary or secondary outcomes,” Dr. Wake reported in an oral presentation at the annual meeting of the Pediatric Academic Societies. “It was both costly and ineffective.”
Among 3,958 children aged 5–12 years who were screened by primary care providers in Melbourne, 947 (24%) were found to be overweight or mildly obese, and were therefore eligible for a 4-session, 12-week intervention during which the provider individually counseled the family in nutrition, physical activity, and sedentary behavior.
A lengthy initial session was aimed at assessing goals and willingness to change, followed by structured consultations. Extensive materials and accelerometers also were provided to each family.
To learn the techniques, 66 general physicians from 45 practices representing a broad socioeconomic range of families attended two 2.5-hour educational sessions that involved interactive DVD sessions and participated with a trained actor in two simulated family consultations.
Ultimately 258 families were enrolled, 139 assigned to the interventional arm and 119 to the control group, which was provided materials and four physician consultations over 3 months.
Impressive advances were seen in physicians' comfort levels and competency in managing childhood obesity, said Dr. Wake.
At least one consultation session was attended by 96% of families. The mean number of sessions attended was 3, with a range of 1–4. Twelve-month follow-up BMI was available for 94% of children enrolled.
Despite this extraordinary level of participation, the results were dismal, with no statistical change seen at 12 months in the children's or parents' BMI, physical activity, nutrition, or body satisfaction/dissatisfaction.
One child in the intervention group actually gained 10 kg, more than 22 pounds, over the year of the study. The only improvement at 12 months was an increase in psychosocial measures among children participating in the intervention group on the Pediatric Quality of Life: 77.7 on a 100-point scale, compared with 74.4 for children assigned to the control group.
The cost per child was over $1,000, although Dr. Wake noted that the individual cost could be reduced to perhaps $412 if trained physicians were each seeing many children.
Nonetheless, if the program were to be extended to the 250,000 overweight and obese children in Australia the cost would be over $100 million.
Dr. Wake quoted Sir Winston Churchill, who said, “No matter how beautiful the strategy, one occasionally has to look at the results.” In this study, the results didn't justify the costs, with potentially important lessons to be learned for policy bodies in Australia, the United States, and the United Kingdom, all of whom are considering brief primary care interventions in an effort to reduce childhood obesity, she said.
Depressed Moms May Downgrade Infants' Food
HONOLULU — Depressed Hispanic mothers are more likely than are nondepressed Hispanic mothers to supplement breast-feeding with water and flavored teas as early as 4–6 weeks and to be giving their babies soda, chips, and syrup-flavored cow's milk by 6–12 months, according to a study of 201 women.
Interestingly, the primary hypothesis for the prospective study—that depressed Hispanic mothers would be more likely to have overweight babies—was not confirmed in the cohort of women recruited during pregnancy and followed for 24 months, Dr. Janet M. Wojcicki reported at the annual meeting of the Pediatric Academic Societies.
Nondepressed mothers were actually more likely to have overweight 6-month-old infants than were those who were depressed, 22% versus 9%, respectively, said Dr. Wojcicki, a fellow in pediatric gastroenterology at the University of California, San Francisco.
However, the feeding patterns established early by depressed mothers could have a later impact on their children's development, health, and body size, she said.
Dr. Wojcicki and associates found a high rate of depression among Hispanic mothers prenatally, when 29% reported depressive symptoms on instruments validated for Spanish-speaking subjects.
At 4–6 weeks post partum, 15% of mothers were depressed. By 6 months and 12 months post partum, rates of depression were 18% and 14%, respectively. A prior history of depression was reported by 11% of the cohort.
Of the total, 92% received assistance from the Women, Infants, and Children nutrition program.
Nearly all of the women (93%) spoke Spanish as a primary language. One-third were married and 40% were living with a partner. Three-quarters were employed and had a high school education or less.
Initially, rates of breast-feeding were very high: 91% at 4–6 weeks with 51% reporting exclusive breast-feeding. However, by that time, 24% were supplementing their infants with liquids other than formula, including water and Yerba Buena, chamomile, and manzanita teas.
Twice as many depressed mothers as their nondepressed peers were supplementing their infants with water and tea at 4–6 weeks, reported Dr. Wojcicki. Other factors associated with the practice were Central and South American ethnicity and mixed feeding practices.
In an interview at the meeting, Dr. Wojcicki said the reasons for early tea supplementation by depressed mothers remain unclear and merit further study. One possibility is that these mothers have a lower tolerance for crying or fussiness in their babies and offer them a bottle as well as the breast to quiet them.
“They may be more desperate,” she said. “We may be measuring some level of anxiety or uncertainty in these mothers.”
A second finding, not fully analyzed, was that mothers who remain depressed demonstrate “important feeding differences” in the latter half of their infants' first year. By the time their babies were 6 months old, 10% of mothers with depressive symptoms were giving them soda, compared with 2% of nondepressed mothers in the study.
That difference remained significant at 12 months, by which time the depressed mothers also were likely to be introducing chips and supplementing cow's milk with sugary flavored syrups.
Dr. Wojcicki said feeding practices among depressed mothers failed to correlate with rapid weight gain or obesity at the 6-month mark, when their infants were far less likely to be overweight than were nondepressed mothers.
She noted that previous research has linked maternal depression to failure to thrive and poor weight gain, suggesting that slow to average weight gain may be the rule in these babies.
Weight trends in the group as a whole were rather alarming, with 26% of infants overweight at 6 months.
HONOLULU — Depressed Hispanic mothers are more likely than are nondepressed Hispanic mothers to supplement breast-feeding with water and flavored teas as early as 4–6 weeks and to be giving their babies soda, chips, and syrup-flavored cow's milk by 6–12 months, according to a study of 201 women.
Interestingly, the primary hypothesis for the prospective study—that depressed Hispanic mothers would be more likely to have overweight babies—was not confirmed in the cohort of women recruited during pregnancy and followed for 24 months, Dr. Janet M. Wojcicki reported at the annual meeting of the Pediatric Academic Societies.
Nondepressed mothers were actually more likely to have overweight 6-month-old infants than were those who were depressed, 22% versus 9%, respectively, said Dr. Wojcicki, a fellow in pediatric gastroenterology at the University of California, San Francisco.
However, the feeding patterns established early by depressed mothers could have a later impact on their children's development, health, and body size, she said.
Dr. Wojcicki and associates found a high rate of depression among Hispanic mothers prenatally, when 29% reported depressive symptoms on instruments validated for Spanish-speaking subjects.
At 4–6 weeks post partum, 15% of mothers were depressed. By 6 months and 12 months post partum, rates of depression were 18% and 14%, respectively. A prior history of depression was reported by 11% of the cohort.
Of the total, 92% received assistance from the Women, Infants, and Children nutrition program.
Nearly all of the women (93%) spoke Spanish as a primary language. One-third were married and 40% were living with a partner. Three-quarters were employed and had a high school education or less.
Initially, rates of breast-feeding were very high: 91% at 4–6 weeks with 51% reporting exclusive breast-feeding. However, by that time, 24% were supplementing their infants with liquids other than formula, including water and Yerba Buena, chamomile, and manzanita teas.
Twice as many depressed mothers as their nondepressed peers were supplementing their infants with water and tea at 4–6 weeks, reported Dr. Wojcicki. Other factors associated with the practice were Central and South American ethnicity and mixed feeding practices.
In an interview at the meeting, Dr. Wojcicki said the reasons for early tea supplementation by depressed mothers remain unclear and merit further study. One possibility is that these mothers have a lower tolerance for crying or fussiness in their babies and offer them a bottle as well as the breast to quiet them.
“They may be more desperate,” she said. “We may be measuring some level of anxiety or uncertainty in these mothers.”
A second finding, not fully analyzed, was that mothers who remain depressed demonstrate “important feeding differences” in the latter half of their infants' first year. By the time their babies were 6 months old, 10% of mothers with depressive symptoms were giving them soda, compared with 2% of nondepressed mothers in the study.
That difference remained significant at 12 months, by which time the depressed mothers also were likely to be introducing chips and supplementing cow's milk with sugary flavored syrups.
Dr. Wojcicki said feeding practices among depressed mothers failed to correlate with rapid weight gain or obesity at the 6-month mark, when their infants were far less likely to be overweight than were nondepressed mothers.
She noted that previous research has linked maternal depression to failure to thrive and poor weight gain, suggesting that slow to average weight gain may be the rule in these babies.
Weight trends in the group as a whole were rather alarming, with 26% of infants overweight at 6 months.
HONOLULU — Depressed Hispanic mothers are more likely than are nondepressed Hispanic mothers to supplement breast-feeding with water and flavored teas as early as 4–6 weeks and to be giving their babies soda, chips, and syrup-flavored cow's milk by 6–12 months, according to a study of 201 women.
Interestingly, the primary hypothesis for the prospective study—that depressed Hispanic mothers would be more likely to have overweight babies—was not confirmed in the cohort of women recruited during pregnancy and followed for 24 months, Dr. Janet M. Wojcicki reported at the annual meeting of the Pediatric Academic Societies.
Nondepressed mothers were actually more likely to have overweight 6-month-old infants than were those who were depressed, 22% versus 9%, respectively, said Dr. Wojcicki, a fellow in pediatric gastroenterology at the University of California, San Francisco.
However, the feeding patterns established early by depressed mothers could have a later impact on their children's development, health, and body size, she said.
Dr. Wojcicki and associates found a high rate of depression among Hispanic mothers prenatally, when 29% reported depressive symptoms on instruments validated for Spanish-speaking subjects.
At 4–6 weeks post partum, 15% of mothers were depressed. By 6 months and 12 months post partum, rates of depression were 18% and 14%, respectively. A prior history of depression was reported by 11% of the cohort.
Of the total, 92% received assistance from the Women, Infants, and Children nutrition program.
Nearly all of the women (93%) spoke Spanish as a primary language. One-third were married and 40% were living with a partner. Three-quarters were employed and had a high school education or less.
Initially, rates of breast-feeding were very high: 91% at 4–6 weeks with 51% reporting exclusive breast-feeding. However, by that time, 24% were supplementing their infants with liquids other than formula, including water and Yerba Buena, chamomile, and manzanita teas.
Twice as many depressed mothers as their nondepressed peers were supplementing their infants with water and tea at 4–6 weeks, reported Dr. Wojcicki. Other factors associated with the practice were Central and South American ethnicity and mixed feeding practices.
In an interview at the meeting, Dr. Wojcicki said the reasons for early tea supplementation by depressed mothers remain unclear and merit further study. One possibility is that these mothers have a lower tolerance for crying or fussiness in their babies and offer them a bottle as well as the breast to quiet them.
“They may be more desperate,” she said. “We may be measuring some level of anxiety or uncertainty in these mothers.”
A second finding, not fully analyzed, was that mothers who remain depressed demonstrate “important feeding differences” in the latter half of their infants' first year. By the time their babies were 6 months old, 10% of mothers with depressive symptoms were giving them soda, compared with 2% of nondepressed mothers in the study.
That difference remained significant at 12 months, by which time the depressed mothers also were likely to be introducing chips and supplementing cow's milk with sugary flavored syrups.
Dr. Wojcicki said feeding practices among depressed mothers failed to correlate with rapid weight gain or obesity at the 6-month mark, when their infants were far less likely to be overweight than were nondepressed mothers.
She noted that previous research has linked maternal depression to failure to thrive and poor weight gain, suggesting that slow to average weight gain may be the rule in these babies.
Weight trends in the group as a whole were rather alarming, with 26% of infants overweight at 6 months.
Lab Tests Find More Infants' Bacterial Infections
HONOLULU – A few simple, inexpensive laboratory tests conducted in the outpatient setting could have identified which febrile infants were likely to have serious bacterial infections and should have been considered candidates for hospital admission, according to the results of a retrospective study of more than 10,000 febrile infants.
Dr. Eric W. Glissmeyer and his associates examined the records of 10,316 febrile infant visits to hospitals and emergency clinics and found that in about half of cases–5,221–the infants were evaluated and discharged home.
Of those, 63 (1%) of the infants were admitted within 3 days of discharge, 23 of them for serious, culture-confirmed bacterial infections, Dr. Glissmeyer said at the annual meeting of the Pediatric Academic Societies.
Bacteremia (10 cases), urinary tract infection (7 cases), bacterial meningitis (5 cases), and salmonella gastroenteritis (1 case) were among the missed cases.
Most of the infections were life threatening, he said.
Among these 23 cases, just one infant had received a complete blood count and a urinalysis with results within normal limits at the initial presentation, conferring a low risk of a serious bacterial infection, reported Dr. Glissmeyer, who was affiliated with the University of Utah, Salt Lake City, at the time of the study.
Another 12 (52%) of these 23 infants were discharged home despite being at high risk for a serious bacterial infection.
Risk assessment was based on laboratory results and the degree of risk was considered high if an infant had a white blood cell count of fewer than 5,000 cells/mcL or more than 15,000 cells/mcL; an absolute band count of greater than 1,500/mm3; and/or more than 10 white blood cells per high-powered-field in a urine sample.
Infants with laboratory results meeting these high-risk criteria had more than a twofold increased likelihood of being readmitted within 3 days for any reason, and for a serious bacterial infection specifically.
No laboratory tests were performed in 10 febrile infants who went on to be hospitalized with a serious bacterial infection within 3 days, said Dr. Glissmeyer, who is now at Children's Hospital Boston.
Consensus guidelines for the management of febrile infants, which were originally issued in 1993 (Ann. Emerg. Med. 22:1198-210), as well as criteria that were developed by several institutions on the basis of prospective studies, routinely recommend performance of a CBC and a urinalysis to detect high-risk infants between the ages of 1 day and 90 days.
Many institutions, including the University of Utah, routinely admit all febrile infants younger than 28 days old.
One reason for that policy is that clinical appearance alone is a poor determinant of risk for serious bacterial infection for febrile infants 1-90 days old, said Dr. Glissmeyer.
“Febrile infants with a missed serious bacterial infection are at risk for serious morbidity and mortality,” Dr. Glissmeyer added.
“Simple laboratory testing, including a CBC and a urinalysis, should be obtained before the decision is made to manage [a febrile infant] as an outpatient,” he concluded.
The study findings prompted the Intermountain Healthcare system to set a goal for 2008 of having 80% of febrile infants seen as outpatients receive a urinalysis, compared with 50%-60% at the beginning of the year.
To date, that goal has been exceeded, with more than 80% of febrile infants receiving both a CBC and a urinalysis in the outpatient setting.
Some barriers had to be overcome to reach this goal, including training rural nurses in how to obtain a catheterized urine sample on a newborn, said Dr. Glissmeyer.
HONOLULU – A few simple, inexpensive laboratory tests conducted in the outpatient setting could have identified which febrile infants were likely to have serious bacterial infections and should have been considered candidates for hospital admission, according to the results of a retrospective study of more than 10,000 febrile infants.
Dr. Eric W. Glissmeyer and his associates examined the records of 10,316 febrile infant visits to hospitals and emergency clinics and found that in about half of cases–5,221–the infants were evaluated and discharged home.
Of those, 63 (1%) of the infants were admitted within 3 days of discharge, 23 of them for serious, culture-confirmed bacterial infections, Dr. Glissmeyer said at the annual meeting of the Pediatric Academic Societies.
Bacteremia (10 cases), urinary tract infection (7 cases), bacterial meningitis (5 cases), and salmonella gastroenteritis (1 case) were among the missed cases.
Most of the infections were life threatening, he said.
Among these 23 cases, just one infant had received a complete blood count and a urinalysis with results within normal limits at the initial presentation, conferring a low risk of a serious bacterial infection, reported Dr. Glissmeyer, who was affiliated with the University of Utah, Salt Lake City, at the time of the study.
Another 12 (52%) of these 23 infants were discharged home despite being at high risk for a serious bacterial infection.
Risk assessment was based on laboratory results and the degree of risk was considered high if an infant had a white blood cell count of fewer than 5,000 cells/mcL or more than 15,000 cells/mcL; an absolute band count of greater than 1,500/mm3; and/or more than 10 white blood cells per high-powered-field in a urine sample.
Infants with laboratory results meeting these high-risk criteria had more than a twofold increased likelihood of being readmitted within 3 days for any reason, and for a serious bacterial infection specifically.
No laboratory tests were performed in 10 febrile infants who went on to be hospitalized with a serious bacterial infection within 3 days, said Dr. Glissmeyer, who is now at Children's Hospital Boston.
Consensus guidelines for the management of febrile infants, which were originally issued in 1993 (Ann. Emerg. Med. 22:1198-210), as well as criteria that were developed by several institutions on the basis of prospective studies, routinely recommend performance of a CBC and a urinalysis to detect high-risk infants between the ages of 1 day and 90 days.
Many institutions, including the University of Utah, routinely admit all febrile infants younger than 28 days old.
One reason for that policy is that clinical appearance alone is a poor determinant of risk for serious bacterial infection for febrile infants 1-90 days old, said Dr. Glissmeyer.
“Febrile infants with a missed serious bacterial infection are at risk for serious morbidity and mortality,” Dr. Glissmeyer added.
“Simple laboratory testing, including a CBC and a urinalysis, should be obtained before the decision is made to manage [a febrile infant] as an outpatient,” he concluded.
The study findings prompted the Intermountain Healthcare system to set a goal for 2008 of having 80% of febrile infants seen as outpatients receive a urinalysis, compared with 50%-60% at the beginning of the year.
To date, that goal has been exceeded, with more than 80% of febrile infants receiving both a CBC and a urinalysis in the outpatient setting.
Some barriers had to be overcome to reach this goal, including training rural nurses in how to obtain a catheterized urine sample on a newborn, said Dr. Glissmeyer.
HONOLULU – A few simple, inexpensive laboratory tests conducted in the outpatient setting could have identified which febrile infants were likely to have serious bacterial infections and should have been considered candidates for hospital admission, according to the results of a retrospective study of more than 10,000 febrile infants.
Dr. Eric W. Glissmeyer and his associates examined the records of 10,316 febrile infant visits to hospitals and emergency clinics and found that in about half of cases–5,221–the infants were evaluated and discharged home.
Of those, 63 (1%) of the infants were admitted within 3 days of discharge, 23 of them for serious, culture-confirmed bacterial infections, Dr. Glissmeyer said at the annual meeting of the Pediatric Academic Societies.
Bacteremia (10 cases), urinary tract infection (7 cases), bacterial meningitis (5 cases), and salmonella gastroenteritis (1 case) were among the missed cases.
Most of the infections were life threatening, he said.
Among these 23 cases, just one infant had received a complete blood count and a urinalysis with results within normal limits at the initial presentation, conferring a low risk of a serious bacterial infection, reported Dr. Glissmeyer, who was affiliated with the University of Utah, Salt Lake City, at the time of the study.
Another 12 (52%) of these 23 infants were discharged home despite being at high risk for a serious bacterial infection.
Risk assessment was based on laboratory results and the degree of risk was considered high if an infant had a white blood cell count of fewer than 5,000 cells/mcL or more than 15,000 cells/mcL; an absolute band count of greater than 1,500/mm3; and/or more than 10 white blood cells per high-powered-field in a urine sample.
Infants with laboratory results meeting these high-risk criteria had more than a twofold increased likelihood of being readmitted within 3 days for any reason, and for a serious bacterial infection specifically.
No laboratory tests were performed in 10 febrile infants who went on to be hospitalized with a serious bacterial infection within 3 days, said Dr. Glissmeyer, who is now at Children's Hospital Boston.
Consensus guidelines for the management of febrile infants, which were originally issued in 1993 (Ann. Emerg. Med. 22:1198-210), as well as criteria that were developed by several institutions on the basis of prospective studies, routinely recommend performance of a CBC and a urinalysis to detect high-risk infants between the ages of 1 day and 90 days.
Many institutions, including the University of Utah, routinely admit all febrile infants younger than 28 days old.
One reason for that policy is that clinical appearance alone is a poor determinant of risk for serious bacterial infection for febrile infants 1-90 days old, said Dr. Glissmeyer.
“Febrile infants with a missed serious bacterial infection are at risk for serious morbidity and mortality,” Dr. Glissmeyer added.
“Simple laboratory testing, including a CBC and a urinalysis, should be obtained before the decision is made to manage [a febrile infant] as an outpatient,” he concluded.
The study findings prompted the Intermountain Healthcare system to set a goal for 2008 of having 80% of febrile infants seen as outpatients receive a urinalysis, compared with 50%-60% at the beginning of the year.
To date, that goal has been exceeded, with more than 80% of febrile infants receiving both a CBC and a urinalysis in the outpatient setting.
Some barriers had to be overcome to reach this goal, including training rural nurses in how to obtain a catheterized urine sample on a newborn, said Dr. Glissmeyer.
Options for Treating Skin Infections in the CA-MRSA Era
HONOLULU – For community-acquired methicillin-resistant Staphylococcus aureus infections of the face, cephalexin should rarely be the antibiotic of choice, according to a decision analysis performed by researchers at the University of California, San Francisco, and presented at the annual meeting of the Pediatric Academic Societies.
A second study, this one from Cardinal Glennon Children's Medical Center in St. Louis, called into question whether an antibiotic is needed at all to treat a primary skin infection if abscesses are incised and drained.
In the San Francisco study, Dr. Adam Hersh and associates from the university weighed the tradeoffs associated with three antibiotic choices–cephalexin, trimethoprim/sulfamethoxazole, or clindamycin–for empiric treatment of a purulent skin infection in a child under the age of 18.
Cephalexin does not treat CA-MRSA; trimethoprim/sulfamethoxazole does not treat group A Streptococcus; while clindamycin treats both, CA-MRSA is becoming increasingly resistant to it in some communities, said Dr. Hersh.
When community physicians consistently culture skin infections and prevalence and resistance rates can be developed, a decision tree analysis can be a method of “exquisitely weighing the tradeoffs between treatment choices,” he commented.
In communities that now have a prevalence of CA-MRSA of greater than 10%, cephalexin is least likely to treat the infection effectively, despite the fact that the drug remains the most widely prescribed antibiotic for this indication, Dr. Hersh and his coauthors reported.
Choosing between trimethoprim/sulfamethoxazole and clindamycin remains a delicate decision, depending on CA-MRSA resistance and prevalence of group A strep in an individual community.
In San Francisco, the overall prevalence of S. aureus in cultures of purulent pediatric skin infections is 90% (80% of them caused by CA-MRSA; 20% caused by methicillin-sensitive S. aureus). Of the remaining 10%, cultures show group A strep more than 99% of the time, said Dr. Hersh during his late-breaking presentation.
Using these figures for a “base case” analysis, he concluded that probability rates for each drug having activity against an empiric skin infection were 95% for clindamycin, 89% for trimethoprim/sulfamethoxazole, and 28% for cephalexin.
Higher group A strep prevalence or high-rate clindamycin resistence in a community would tilt the decision tree model to trimethoprim/sulfamethoxazole or cephalexin, but it would be the rare community in which CA-MRSA prevalence was so low it would favor cephalexin for skin infections or other CA-MRSA affected conditions such as osteomyelitis or septic arthritis, said Dr. Hersh.
Dr. Myto Duong and associates in St. Louis selected trimethoprim/sulfamethoxazole for a randomized, controlled, double-blind trial comparing antibiotic treatment of skin and soft tissue infections with treatment with incision and drainage in 161 immunocompetent children.
All patients presented to the emergency department at Cardinal Glennon Children's Medical Center. About half of the children were less than 5 years old.
Wound cultures revealed CA-MRSA in 129 children (80%)–with 18% clindamycin resistant as well–and methicillin-sensitive Streptococcus aureus in 14 (9%). Other bacteria were responsible for the infections in the remaining cases, including group A strep in 1%.
Twelve patients were lost to follow-up.
Among patients with complete data available, complete resolution of the lesions was seen in 95% receiving a placebo following incision and drainage (with or without wound packing). Complete resolution was also seen in 96% of those who received incision, drainage, and a 10-day antibiotic prescription filled in the emergency department before children were discharged.
Compliance, defined as taking at least half of the medication prescribed, was poor, at just 66%.
Development of a new purulent skin lesion following treatment was equally likely in compliant patients receiving the antibiotic or placebo.
However, in the noncompliant subset, receipt of an antibiotic reduced the risk of developing a new purulent skin lesion. In this group, 23% of those receiving placebo developed a new lesion, compared with 4% who received an antibiotic prescription at the emergency department.
“Antibiotics may be useful in specific cases,” concluded Dr. Duong.
Both Dr. Hersh and Dr. Duong stated that they had no relevant financial conflicts to disclose.
HONOLULU – For community-acquired methicillin-resistant Staphylococcus aureus infections of the face, cephalexin should rarely be the antibiotic of choice, according to a decision analysis performed by researchers at the University of California, San Francisco, and presented at the annual meeting of the Pediatric Academic Societies.
A second study, this one from Cardinal Glennon Children's Medical Center in St. Louis, called into question whether an antibiotic is needed at all to treat a primary skin infection if abscesses are incised and drained.
In the San Francisco study, Dr. Adam Hersh and associates from the university weighed the tradeoffs associated with three antibiotic choices–cephalexin, trimethoprim/sulfamethoxazole, or clindamycin–for empiric treatment of a purulent skin infection in a child under the age of 18.
Cephalexin does not treat CA-MRSA; trimethoprim/sulfamethoxazole does not treat group A Streptococcus; while clindamycin treats both, CA-MRSA is becoming increasingly resistant to it in some communities, said Dr. Hersh.
When community physicians consistently culture skin infections and prevalence and resistance rates can be developed, a decision tree analysis can be a method of “exquisitely weighing the tradeoffs between treatment choices,” he commented.
In communities that now have a prevalence of CA-MRSA of greater than 10%, cephalexin is least likely to treat the infection effectively, despite the fact that the drug remains the most widely prescribed antibiotic for this indication, Dr. Hersh and his coauthors reported.
Choosing between trimethoprim/sulfamethoxazole and clindamycin remains a delicate decision, depending on CA-MRSA resistance and prevalence of group A strep in an individual community.
In San Francisco, the overall prevalence of S. aureus in cultures of purulent pediatric skin infections is 90% (80% of them caused by CA-MRSA; 20% caused by methicillin-sensitive S. aureus). Of the remaining 10%, cultures show group A strep more than 99% of the time, said Dr. Hersh during his late-breaking presentation.
Using these figures for a “base case” analysis, he concluded that probability rates for each drug having activity against an empiric skin infection were 95% for clindamycin, 89% for trimethoprim/sulfamethoxazole, and 28% for cephalexin.
Higher group A strep prevalence or high-rate clindamycin resistence in a community would tilt the decision tree model to trimethoprim/sulfamethoxazole or cephalexin, but it would be the rare community in which CA-MRSA prevalence was so low it would favor cephalexin for skin infections or other CA-MRSA affected conditions such as osteomyelitis or septic arthritis, said Dr. Hersh.
Dr. Myto Duong and associates in St. Louis selected trimethoprim/sulfamethoxazole for a randomized, controlled, double-blind trial comparing antibiotic treatment of skin and soft tissue infections with treatment with incision and drainage in 161 immunocompetent children.
All patients presented to the emergency department at Cardinal Glennon Children's Medical Center. About half of the children were less than 5 years old.
Wound cultures revealed CA-MRSA in 129 children (80%)–with 18% clindamycin resistant as well–and methicillin-sensitive Streptococcus aureus in 14 (9%). Other bacteria were responsible for the infections in the remaining cases, including group A strep in 1%.
Twelve patients were lost to follow-up.
Among patients with complete data available, complete resolution of the lesions was seen in 95% receiving a placebo following incision and drainage (with or without wound packing). Complete resolution was also seen in 96% of those who received incision, drainage, and a 10-day antibiotic prescription filled in the emergency department before children were discharged.
Compliance, defined as taking at least half of the medication prescribed, was poor, at just 66%.
Development of a new purulent skin lesion following treatment was equally likely in compliant patients receiving the antibiotic or placebo.
However, in the noncompliant subset, receipt of an antibiotic reduced the risk of developing a new purulent skin lesion. In this group, 23% of those receiving placebo developed a new lesion, compared with 4% who received an antibiotic prescription at the emergency department.
“Antibiotics may be useful in specific cases,” concluded Dr. Duong.
Both Dr. Hersh and Dr. Duong stated that they had no relevant financial conflicts to disclose.
HONOLULU – For community-acquired methicillin-resistant Staphylococcus aureus infections of the face, cephalexin should rarely be the antibiotic of choice, according to a decision analysis performed by researchers at the University of California, San Francisco, and presented at the annual meeting of the Pediatric Academic Societies.
A second study, this one from Cardinal Glennon Children's Medical Center in St. Louis, called into question whether an antibiotic is needed at all to treat a primary skin infection if abscesses are incised and drained.
In the San Francisco study, Dr. Adam Hersh and associates from the university weighed the tradeoffs associated with three antibiotic choices–cephalexin, trimethoprim/sulfamethoxazole, or clindamycin–for empiric treatment of a purulent skin infection in a child under the age of 18.
Cephalexin does not treat CA-MRSA; trimethoprim/sulfamethoxazole does not treat group A Streptococcus; while clindamycin treats both, CA-MRSA is becoming increasingly resistant to it in some communities, said Dr. Hersh.
When community physicians consistently culture skin infections and prevalence and resistance rates can be developed, a decision tree analysis can be a method of “exquisitely weighing the tradeoffs between treatment choices,” he commented.
In communities that now have a prevalence of CA-MRSA of greater than 10%, cephalexin is least likely to treat the infection effectively, despite the fact that the drug remains the most widely prescribed antibiotic for this indication, Dr. Hersh and his coauthors reported.
Choosing between trimethoprim/sulfamethoxazole and clindamycin remains a delicate decision, depending on CA-MRSA resistance and prevalence of group A strep in an individual community.
In San Francisco, the overall prevalence of S. aureus in cultures of purulent pediatric skin infections is 90% (80% of them caused by CA-MRSA; 20% caused by methicillin-sensitive S. aureus). Of the remaining 10%, cultures show group A strep more than 99% of the time, said Dr. Hersh during his late-breaking presentation.
Using these figures for a “base case” analysis, he concluded that probability rates for each drug having activity against an empiric skin infection were 95% for clindamycin, 89% for trimethoprim/sulfamethoxazole, and 28% for cephalexin.
Higher group A strep prevalence or high-rate clindamycin resistence in a community would tilt the decision tree model to trimethoprim/sulfamethoxazole or cephalexin, but it would be the rare community in which CA-MRSA prevalence was so low it would favor cephalexin for skin infections or other CA-MRSA affected conditions such as osteomyelitis or septic arthritis, said Dr. Hersh.
Dr. Myto Duong and associates in St. Louis selected trimethoprim/sulfamethoxazole for a randomized, controlled, double-blind trial comparing antibiotic treatment of skin and soft tissue infections with treatment with incision and drainage in 161 immunocompetent children.
All patients presented to the emergency department at Cardinal Glennon Children's Medical Center. About half of the children were less than 5 years old.
Wound cultures revealed CA-MRSA in 129 children (80%)–with 18% clindamycin resistant as well–and methicillin-sensitive Streptococcus aureus in 14 (9%). Other bacteria were responsible for the infections in the remaining cases, including group A strep in 1%.
Twelve patients were lost to follow-up.
Among patients with complete data available, complete resolution of the lesions was seen in 95% receiving a placebo following incision and drainage (with or without wound packing). Complete resolution was also seen in 96% of those who received incision, drainage, and a 10-day antibiotic prescription filled in the emergency department before children were discharged.
Compliance, defined as taking at least half of the medication prescribed, was poor, at just 66%.
Development of a new purulent skin lesion following treatment was equally likely in compliant patients receiving the antibiotic or placebo.
However, in the noncompliant subset, receipt of an antibiotic reduced the risk of developing a new purulent skin lesion. In this group, 23% of those receiving placebo developed a new lesion, compared with 4% who received an antibiotic prescription at the emergency department.
“Antibiotics may be useful in specific cases,” concluded Dr. Duong.
Both Dr. Hersh and Dr. Duong stated that they had no relevant financial conflicts to disclose.
Six-Gene Cluster Stratifies Need for Colonoscopy
SAN DIEGO — The probability of colorectal cancer in asymptomatic patients can be fairly accurately stratified by RNA expression profiling of six genes detectable in whole blood, researchers reported at the annual meeting of the American Association for Cancer Research.
The finding may enable clinicians to prescreen and risk stratify reluctant candidates for screening colonoscopy, poster presenter Dr. Wayne Marshall, president/CEO of GeneNews Corp. of Richmond Hill (Ont.), suggested in an interview at the meeting.
The company has announced plans to launch a laboratory test, ColonSentry, based on the six-gene panel, by the third quarter of this year in Canada.
Fewer than half of Americans comply with recommended colorectal cancer screening guidelines, with far lower compliance—about 15%—in Canada and Western Europe, Dr. Marshall noted.
The ColonSentry pattern of molecular blood markers was developed by the company's chief scientist, Dr. Choon-Cin Liew, who was formerly a researcher in microarray technology aimed at bladder cancer and heart disease at Brigham and Women's Hospital and Harvard Medical School, both in Boston. Dr. Liew cofounded GeneNews with Dr. Marshall, an orthopedic surgeon and joint neurophysiology researcher.
Preliminary research identified six genes (ANXA3, CLEC4D, LMNB1, PRRG4, VNN1, and IL2RB) whose expression could meaningfully discriminate between blood samples provided by 116 patients with colorectal cancer and 127 control subjects. The six genes had an accuracy of 74.6% (area under the receiver operating characteristic [ROC] curve, 0.79; 95% confidence interval, 0.73–0.84)
A confirmatory, blinded, independent study of samples from 166 colorectal cancer patients and 171 controls confirmed the area under the curve and found the panel was 70.3% accurate, including 127 true-positive, 39 false-positive, 110 true-negative, and 61 false-positive results (Clin. Cancer Res. 2008;14:455–60.)
These data were then combined with the known colorectal prevalence rate of 0.5% in an average-risk population to create a three-tier probability matrix:
▸ Based on their six-gene profiles, an estimated 18% of this population would receive a “high probability” designation, suggesting a 1.5% risk of colorectal cancer, a threefold increase over baseline risk.
▸ Another 20% of this population would be at average risk, with a 0.62% probability of having colorectal cancer.
▸ Finally, 62% of this population would fall into the “low probability” designation, with a 0.16% risk of colorectal cancer, a threefold decreased risk from baseline.
Receiving news of a “high probability” designation would place a patient at approximately the same risk as a person with a first-degree relative with colorectal cancer, Dr. Marshall said. “They are no longer an average-risk person. I think very few folks armed with that information would not undergo screening,” he said.
At the other end of the spectrum are the majority of patients who learn they have a lower than average risk for colorectal cancer. In this case, unless symptoms arise, the risk of complications from colonoscopy would likely outweigh the risk of cancer, Dr. Marshall said.
“As a front-line screening tool [for lower than average risk patients], colonoscopy is arguably overkill,” he added. “Information that is clinically actionable occurs at both ends of the scale.”
Although a price has not been set for the ColonSentry test, it will cost more than a prostate-specific antigen test and far less than a colonoscopy, Dr. Marshall said.
At first, the test will be performed in a designated laboratory. The company intends to pursue Food and Drug Administration certification so the test can be performed by laboratories meeting criteria of the Clinical Laboratory Improvement Amendment approved by the Centers for Medicare and Medicaid Services.
SAN DIEGO — The probability of colorectal cancer in asymptomatic patients can be fairly accurately stratified by RNA expression profiling of six genes detectable in whole blood, researchers reported at the annual meeting of the American Association for Cancer Research.
The finding may enable clinicians to prescreen and risk stratify reluctant candidates for screening colonoscopy, poster presenter Dr. Wayne Marshall, president/CEO of GeneNews Corp. of Richmond Hill (Ont.), suggested in an interview at the meeting.
The company has announced plans to launch a laboratory test, ColonSentry, based on the six-gene panel, by the third quarter of this year in Canada.
Fewer than half of Americans comply with recommended colorectal cancer screening guidelines, with far lower compliance—about 15%—in Canada and Western Europe, Dr. Marshall noted.
The ColonSentry pattern of molecular blood markers was developed by the company's chief scientist, Dr. Choon-Cin Liew, who was formerly a researcher in microarray technology aimed at bladder cancer and heart disease at Brigham and Women's Hospital and Harvard Medical School, both in Boston. Dr. Liew cofounded GeneNews with Dr. Marshall, an orthopedic surgeon and joint neurophysiology researcher.
Preliminary research identified six genes (ANXA3, CLEC4D, LMNB1, PRRG4, VNN1, and IL2RB) whose expression could meaningfully discriminate between blood samples provided by 116 patients with colorectal cancer and 127 control subjects. The six genes had an accuracy of 74.6% (area under the receiver operating characteristic [ROC] curve, 0.79; 95% confidence interval, 0.73–0.84)
A confirmatory, blinded, independent study of samples from 166 colorectal cancer patients and 171 controls confirmed the area under the curve and found the panel was 70.3% accurate, including 127 true-positive, 39 false-positive, 110 true-negative, and 61 false-positive results (Clin. Cancer Res. 2008;14:455–60.)
These data were then combined with the known colorectal prevalence rate of 0.5% in an average-risk population to create a three-tier probability matrix:
▸ Based on their six-gene profiles, an estimated 18% of this population would receive a “high probability” designation, suggesting a 1.5% risk of colorectal cancer, a threefold increase over baseline risk.
▸ Another 20% of this population would be at average risk, with a 0.62% probability of having colorectal cancer.
▸ Finally, 62% of this population would fall into the “low probability” designation, with a 0.16% risk of colorectal cancer, a threefold decreased risk from baseline.
Receiving news of a “high probability” designation would place a patient at approximately the same risk as a person with a first-degree relative with colorectal cancer, Dr. Marshall said. “They are no longer an average-risk person. I think very few folks armed with that information would not undergo screening,” he said.
At the other end of the spectrum are the majority of patients who learn they have a lower than average risk for colorectal cancer. In this case, unless symptoms arise, the risk of complications from colonoscopy would likely outweigh the risk of cancer, Dr. Marshall said.
“As a front-line screening tool [for lower than average risk patients], colonoscopy is arguably overkill,” he added. “Information that is clinically actionable occurs at both ends of the scale.”
Although a price has not been set for the ColonSentry test, it will cost more than a prostate-specific antigen test and far less than a colonoscopy, Dr. Marshall said.
At first, the test will be performed in a designated laboratory. The company intends to pursue Food and Drug Administration certification so the test can be performed by laboratories meeting criteria of the Clinical Laboratory Improvement Amendment approved by the Centers for Medicare and Medicaid Services.
SAN DIEGO — The probability of colorectal cancer in asymptomatic patients can be fairly accurately stratified by RNA expression profiling of six genes detectable in whole blood, researchers reported at the annual meeting of the American Association for Cancer Research.
The finding may enable clinicians to prescreen and risk stratify reluctant candidates for screening colonoscopy, poster presenter Dr. Wayne Marshall, president/CEO of GeneNews Corp. of Richmond Hill (Ont.), suggested in an interview at the meeting.
The company has announced plans to launch a laboratory test, ColonSentry, based on the six-gene panel, by the third quarter of this year in Canada.
Fewer than half of Americans comply with recommended colorectal cancer screening guidelines, with far lower compliance—about 15%—in Canada and Western Europe, Dr. Marshall noted.
The ColonSentry pattern of molecular blood markers was developed by the company's chief scientist, Dr. Choon-Cin Liew, who was formerly a researcher in microarray technology aimed at bladder cancer and heart disease at Brigham and Women's Hospital and Harvard Medical School, both in Boston. Dr. Liew cofounded GeneNews with Dr. Marshall, an orthopedic surgeon and joint neurophysiology researcher.
Preliminary research identified six genes (ANXA3, CLEC4D, LMNB1, PRRG4, VNN1, and IL2RB) whose expression could meaningfully discriminate between blood samples provided by 116 patients with colorectal cancer and 127 control subjects. The six genes had an accuracy of 74.6% (area under the receiver operating characteristic [ROC] curve, 0.79; 95% confidence interval, 0.73–0.84)
A confirmatory, blinded, independent study of samples from 166 colorectal cancer patients and 171 controls confirmed the area under the curve and found the panel was 70.3% accurate, including 127 true-positive, 39 false-positive, 110 true-negative, and 61 false-positive results (Clin. Cancer Res. 2008;14:455–60.)
These data were then combined with the known colorectal prevalence rate of 0.5% in an average-risk population to create a three-tier probability matrix:
▸ Based on their six-gene profiles, an estimated 18% of this population would receive a “high probability” designation, suggesting a 1.5% risk of colorectal cancer, a threefold increase over baseline risk.
▸ Another 20% of this population would be at average risk, with a 0.62% probability of having colorectal cancer.
▸ Finally, 62% of this population would fall into the “low probability” designation, with a 0.16% risk of colorectal cancer, a threefold decreased risk from baseline.
Receiving news of a “high probability” designation would place a patient at approximately the same risk as a person with a first-degree relative with colorectal cancer, Dr. Marshall said. “They are no longer an average-risk person. I think very few folks armed with that information would not undergo screening,” he said.
At the other end of the spectrum are the majority of patients who learn they have a lower than average risk for colorectal cancer. In this case, unless symptoms arise, the risk of complications from colonoscopy would likely outweigh the risk of cancer, Dr. Marshall said.
“As a front-line screening tool [for lower than average risk patients], colonoscopy is arguably overkill,” he added. “Information that is clinically actionable occurs at both ends of the scale.”
Although a price has not been set for the ColonSentry test, it will cost more than a prostate-specific antigen test and far less than a colonoscopy, Dr. Marshall said.
At first, the test will be performed in a designated laboratory. The company intends to pursue Food and Drug Administration certification so the test can be performed by laboratories meeting criteria of the Clinical Laboratory Improvement Amendment approved by the Centers for Medicare and Medicaid Services.