Damian McNamara

MIAMI BEACH — An effective fight against increasing resistance to tuberculosis treatment worldwide may require rethinking of the World Health Organization's recommended standard treatment regimen, David Olson, M.D., said at the annual meeting of the American Society of Tropical Medicine and Hygiene.

“The feeling now is that the standardized retreatment regimen is going to cause greater drug resistance. We're going to have to abandon that protocol and start patients on second-line therapies sooner with susceptibility testing,” said Dr. Olson of Médecins Sans Frontièrs in New York City. However, second-line agents come with their own challenges.

Of the estimated 8 million people infected with tuberculosis worldwide, there are 300,000 with multidrug-resistant infections, according to the WHO. “It means we're not all going to die tomorrow, but it means these people can infect other people,” Lee B. Reichman, M.D., executive director of the New Jersey Medical School National Tuberculosis Center at the University of Medicine and Dentistry of New Jersey, Newark, said in an interview.

In 2003, foreign-born individuals accounted for 53% of all tuberculosis in the United States. “Every American doctor has to be concerned, especially if they see foreign-born individuals,” Dr. Reichman said. Tuberculosis acquired abroad poses a risk of infection to Americans when these individuals enter or return to the United States. The risk is greatest at ports of entry—in particular, Hawaii, California, Massachusetts, Florida, and New York.

Many factors contribute to multidrug-resistant tuberculosis (MDRTB). For example, a physician who does not recognize a resistant case might prescribe first-line treatment and delay more effective, second-line therapy. Also, patient noncompliance can be an issue, as can HIV coinfection or patients who require repeated treatment.

Duration of treatment also affects compliance. Recommended first-line treatment is prescribed for 6 months, compared with 18 months-2 years for second-line agents. Watching patients take their medication is a strategy in the WHO's Directly Observed Treatment, Short-Course-Plus (DOTS-Plus) initiative.

“Studies have shown that many patients with MDRTB can be cured by combinations of reserve second-line anti-TB drugs. Unfortunately, these drugs are weaker than standard therapy, cause adverse reactions difficult for patients to tolerate, have to be taken for prolonged periods to prevent relapse, and are very expensive,” WHO experts noted in a 2000 report, “DOTS-Plus Pilot Projects for the Management of Multidrug-Resistant Tuberculosis.”

The WHO-recommended regimen for new cases of tuberculosis is isoniazid, rifampin, pyrazinamide, and ethambutol taken daily or 3 times a week under direct observation. Isoniazid and rifampicin are the most powerful weapons against tuberculosis bacilli, but growing resistance—particularly to isoniazid—may necessitate a different approach for the WHO to meet its goal of 85% cure of sputum smear-positive cases by 2005.

There have been no new classes of drugs approved specifically for tuberculosis in more than 40 years. Experts agree that the availability of new tuberculosis agents would help combat resistance, especially shorter duration treatments. “A drug that would work in 2 months would decrease costs by 65%, expand access to treatment, slow or stop resistance, and allow health personnel to be redeployed,” Joelle Tanguy, director of advocacy for the Global Alliance for TB Drug Development, New York City, said during a separate presentation at the meeting.

Visit www.umdnj.edu/ntbcweb

MIAMI BEACH — An effective fight against increasing resistance to tuberculosis treatment worldwide may require rethinking of the World Health Organization's recommended standard treatment regimen, David Olson, M.D., said at the annual meeting of the American Society of Tropical Medicine and Hygiene.

“The feeling now is that the standardized retreatment regimen is going to cause greater drug resistance. We're going to have to abandon that protocol and start patients on second-line therapies sooner with susceptibility testing,” said Dr. Olson of Médecins Sans Frontièrs in New York City. However, second-line agents come with their own challenges.

Of the estimated 8 million people infected with tuberculosis worldwide, there are 300,000 with multidrug-resistant infections, according to the WHO. “It means we're not all going to die tomorrow, but it means these people can infect other people,” Lee B. Reichman, M.D., executive director of the New Jersey Medical School National Tuberculosis Center at the University of Medicine and Dentistry of New Jersey, Newark, said in an interview.

In 2003, foreign-born individuals accounted for 53% of all tuberculosis in the United States. “Every American doctor has to be concerned, especially if they see foreign-born individuals,” Dr. Reichman said. Tuberculosis acquired abroad poses a risk of infection to Americans when these individuals enter or return to the United States. The risk is greatest at ports of entry—in particular, Hawaii, California, Massachusetts, Florida, and New York.

Many factors contribute to multidrug-resistant tuberculosis (MDRTB). For example, a physician who does not recognize a resistant case might prescribe first-line treatment and delay more effective, second-line therapy. Also, patient noncompliance can be an issue, as can HIV coinfection or patients who require repeated treatment.

Duration of treatment also affects compliance. Recommended first-line treatment is prescribed for 6 months, compared with 18 months-2 years for second-line agents. Watching patients take their medication is a strategy in the WHO's Directly Observed Treatment, Short-Course-Plus (DOTS-Plus) initiative.

“Studies have shown that many patients with MDRTB can be cured by combinations of reserve second-line anti-TB drugs. Unfortunately, these drugs are weaker than standard therapy, cause adverse reactions difficult for patients to tolerate, have to be taken for prolonged periods to prevent relapse, and are very expensive,” WHO experts noted in a 2000 report, “DOTS-Plus Pilot Projects for the Management of Multidrug-Resistant Tuberculosis.”

The WHO-recommended regimen for new cases of tuberculosis is isoniazid, rifampin, pyrazinamide, and ethambutol taken daily or 3 times a week under direct observation. Isoniazid and rifampicin are the most powerful weapons against tuberculosis bacilli, but growing resistance—particularly to isoniazid—may necessitate a different approach for the WHO to meet its goal of 85% cure of sputum smear-positive cases by 2005.

There have been no new classes of drugs approved specifically for tuberculosis in more than 40 years. Experts agree that the availability of new tuberculosis agents would help combat resistance, especially shorter duration treatments. “A drug that would work in 2 months would decrease costs by 65%, expand access to treatment, slow or stop resistance, and allow health personnel to be redeployed,” Joelle Tanguy, director of advocacy for the Global Alliance for TB Drug Development, New York City, said during a separate presentation at the meeting.

Visit www.umdnj.edu/ntbcweb

MIAMI BEACH — An effective fight against increasing resistance to tuberculosis treatment worldwide may require rethinking of the World Health Organization's recommended standard treatment regimen, David Olson, M.D., said at the annual meeting of the American Society of Tropical Medicine and Hygiene.

“The feeling now is that the standardized retreatment regimen is going to cause greater drug resistance. We're going to have to abandon that protocol and start patients on second-line therapies sooner with susceptibility testing,” said Dr. Olson of Médecins Sans Frontièrs in New York City. However, second-line agents come with their own challenges.

Of the estimated 8 million people infected with tuberculosis worldwide, there are 300,000 with multidrug-resistant infections, according to the WHO. “It means we're not all going to die tomorrow, but it means these people can infect other people,” Lee B. Reichman, M.D., executive director of the New Jersey Medical School National Tuberculosis Center at the University of Medicine and Dentistry of New Jersey, Newark, said in an interview.

In 2003, foreign-born individuals accounted for 53% of all tuberculosis in the United States. “Every American doctor has to be concerned, especially if they see foreign-born individuals,” Dr. Reichman said. Tuberculosis acquired abroad poses a risk of infection to Americans when these individuals enter or return to the United States. The risk is greatest at ports of entry—in particular, Hawaii, California, Massachusetts, Florida, and New York.

Many factors contribute to multidrug-resistant tuberculosis (MDRTB). For example, a physician who does not recognize a resistant case might prescribe first-line treatment and delay more effective, second-line therapy. Also, patient noncompliance can be an issue, as can HIV coinfection or patients who require repeated treatment.

Duration of treatment also affects compliance. Recommended first-line treatment is prescribed for 6 months, compared with 18 months-2 years for second-line agents. Watching patients take their medication is a strategy in the WHO's Directly Observed Treatment, Short-Course-Plus (DOTS-Plus) initiative.

“Studies have shown that many patients with MDRTB can be cured by combinations of reserve second-line anti-TB drugs. Unfortunately, these drugs are weaker than standard therapy, cause adverse reactions difficult for patients to tolerate, have to be taken for prolonged periods to prevent relapse, and are very expensive,” WHO experts noted in a 2000 report, “DOTS-Plus Pilot Projects for the Management of Multidrug-Resistant Tuberculosis.”

The WHO-recommended regimen for new cases of tuberculosis is isoniazid, rifampin, pyrazinamide, and ethambutol taken daily or 3 times a week under direct observation. Isoniazid and rifampicin are the most powerful weapons against tuberculosis bacilli, but growing resistance—particularly to isoniazid—may necessitate a different approach for the WHO to meet its goal of 85% cure of sputum smear-positive cases by 2005.

There have been no new classes of drugs approved specifically for tuberculosis in more than 40 years. Experts agree that the availability of new tuberculosis agents would help combat resistance, especially shorter duration treatments. “A drug that would work in 2 months would decrease costs by 65%, expand access to treatment, slow or stop resistance, and allow health personnel to be redeployed,” Joelle Tanguy, director of advocacy for the Global Alliance for TB Drug Development, New York City, said during a separate presentation at the meeting.

Visit www.umdnj.edu/ntbcweb

MIAMI – The blades roared overhead as the Miami-Dade rescue helicopter approached the rooftop of University of Miami/Jackson Memorial Hospital shortly after dark.

Through the rain, emergency medical technicians rushed a pregnant woman injured in a car crash on Interstate 95. Doctors delivered the distressed baby via emergency cesarean section. An ob.gyn. administered oxygen, and the hypoxic newborn's color turned from blue to pink.

But these moments of high medical drama were not real. “Give the mother a fatal heart rhythm, and let's see how they respond,” said Chris Gallagher, M.D., of the department of anesthesiology at the University of Miami. He was addressing a technician in a control room separated from the activity in the emergency room by a one-way mirror.

The large crowd attending the grand opening of the University of Miami/Jackson Memorial Hospital Center for Patient Safety gathered closer around extra video monitors that had been set up so they could watch the simulated emergency unfold.

The “bloody” actress on the gurney was deftly switched for one of the new, state-of-the-art mannequins that are kept in residence at the new center. After the crew had stabilized both the mother and baby mannequins, they gathered around a conference table on the hospital's renovated fourth floor for a debriefing of their performance.

The emergency scenario was staged as a kickoff for the first patient safety center of its kind in the United States, one that combines simulation with elements of engineering, ergonomic design, and high-tech monitoring and recording.

Akin to a flight simulator for airline pilots, the emergency care component of the Center for Patient Safety challenges physicians and other health care workers in a realistic but safe environment where no patient is harmed.

The 2,000-square-foot simulation facility will be used to provide courses to enhance clinical, communication, and teamwork skills for health care professionals at all levels of training. The simulation facility currently trains medical students and anesthesiology residents.

Courses are planned for multidisciplinary team training of residents and nurses in internal medicine, pediatrics, emergency medicine, obstetrics, and other specialties.

“It's a dream come true after 10 years,” said Paul Barach, M.D., director of the Center for Patient Safety.

The center is innovative for bringing together all of the major elements of patient safety. “I'm most proud of the integration,” said Dr. Barach, also of the department of anesthesiology at the university.

Although other institutions in the United States have some features of the program, he said, the center at the University of Miami is the only one that combines skill assessments simulation, an investigative team to debrief participants, a human factors and usability lab, and a strategy for promoting patient safety policies in Miami, the state of Florida, and, eventually, nationwide.

The center's immediate goals include developing and disseminating training programs for physicians, nurses, pharmacists, and risk managers; enhancing research on patient safety; and working with medical device companies to use better design and ergonomics to make their products safer.

Backed by an initial $5 million in funding from federal, state, and private sources, the center has 18 projects underway. (For more details, visit www.patientsafety.med.miami.edu

The patient safety center was developed with input from the university's schools of engineering, design, nursing, and business, as well as from experts outside of the university.

Dr. Barach's drive to establish the center stemmed in part from a medical error he experienced as a medical student.

“I was told to do a central line procedure, but not told how to do it. The intern just told me to do it. I was just out of the military and did not question orders,” he said. “The patient suffered a hemothorax, was intubated, went to the ICU, and she died 4 days later.”

The experience haunted him for years, he said.

Although the mannequins are the focal point in each of the five skills assessment areas–three exam rooms, an operating room, and a room that can function as an ICU, emergency room, or ward room, “the focus is not on simulation, the focus is on the patient,” John C. Nelson, M.D., president of the American Medical Association, said during the center's opening celebration.

“Patient safety has to be much more on the minds of all of us,” Dr. Nelson said. “This is what our patients expect and our profession demands.”

Patient-centered goals of the center staff include developing better ways to disclose medical errors to patients and their families. Another goal is to identify the factors that patients consider when choosing a hospital, and how these may differ by cultural or ethnic identity, Dr. Barach explained.

“Despite our best intentions, we make mistakes,” Dr. Gallagher said. The intention of the center directors is to solve problems, not to point fingers or assign blame when a medical error occurs.

“The debriefing is really the heart of the simulation. It is where we try to make sense of what happened in the ICU or emergency room chaos.” Participants review recorded actions, discuss what happened, suggest what they would do differently in the future, and, if an error occurs, explain how they would inform a patient or family.

“At the end of the day, all this is about is changing the culture to help people to do the right thing,” Dr. Barach said.

The University of Miami added a 4-year curriculum on patient safety for medical students. The simulation challenges are designed to be relatively simple for students but are more complicated for experienced physicians, Dr. Barach said.

“The long-term goals are to get the center to be a vital part of the community,” he said.

“We want to get throughput from medical students, practicing physicians, and nurses. We also want patient safety to become part of the certification process.”

MIAMI – The blades roared overhead as the Miami-Dade rescue helicopter approached the rooftop of University of Miami/Jackson Memorial Hospital shortly after dark.

Through the rain, emergency medical technicians rushed a pregnant woman injured in a car crash on Interstate 95. Doctors delivered the distressed baby via emergency cesarean section. An ob.gyn. administered oxygen, and the hypoxic newborn's color turned from blue to pink.

But these moments of high medical drama were not real. “Give the mother a fatal heart rhythm, and let's see how they respond,” said Chris Gallagher, M.D., of the department of anesthesiology at the University of Miami. He was addressing a technician in a control room separated from the activity in the emergency room by a one-way mirror.

The large crowd attending the grand opening of the University of Miami/Jackson Memorial Hospital Center for Patient Safety gathered closer around extra video monitors that had been set up so they could watch the simulated emergency unfold.

The “bloody” actress on the gurney was deftly switched for one of the new, state-of-the-art mannequins that are kept in residence at the new center. After the crew had stabilized both the mother and baby mannequins, they gathered around a conference table on the hospital's renovated fourth floor for a debriefing of their performance.

The emergency scenario was staged as a kickoff for the first patient safety center of its kind in the United States, one that combines simulation with elements of engineering, ergonomic design, and high-tech monitoring and recording.

Akin to a flight simulator for airline pilots, the emergency care component of the Center for Patient Safety challenges physicians and other health care workers in a realistic but safe environment where no patient is harmed.

The 2,000-square-foot simulation facility will be used to provide courses to enhance clinical, communication, and teamwork skills for health care professionals at all levels of training. The simulation facility currently trains medical students and anesthesiology residents.

Courses are planned for multidisciplinary team training of residents and nurses in internal medicine, pediatrics, emergency medicine, obstetrics, and other specialties.

“It's a dream come true after 10 years,” said Paul Barach, M.D., director of the Center for Patient Safety.

The center is innovative for bringing together all of the major elements of patient safety. “I'm most proud of the integration,” said Dr. Barach, also of the department of anesthesiology at the university.

Although other institutions in the United States have some features of the program, he said, the center at the University of Miami is the only one that combines skill assessments simulation, an investigative team to debrief participants, a human factors and usability lab, and a strategy for promoting patient safety policies in Miami, the state of Florida, and, eventually, nationwide.

The center's immediate goals include developing and disseminating training programs for physicians, nurses, pharmacists, and risk managers; enhancing research on patient safety; and working with medical device companies to use better design and ergonomics to make their products safer.

Backed by an initial $5 million in funding from federal, state, and private sources, the center has 18 projects underway. (For more details, visit www.patientsafety.med.miami.edu

The patient safety center was developed with input from the university's schools of engineering, design, nursing, and business, as well as from experts outside of the university.

Dr. Barach's drive to establish the center stemmed in part from a medical error he experienced as a medical student.

“I was told to do a central line procedure, but not told how to do it. The intern just told me to do it. I was just out of the military and did not question orders,” he said. “The patient suffered a hemothorax, was intubated, went to the ICU, and she died 4 days later.”

The experience haunted him for years, he said.

Although the mannequins are the focal point in each of the five skills assessment areas–three exam rooms, an operating room, and a room that can function as an ICU, emergency room, or ward room, “the focus is not on simulation, the focus is on the patient,” John C. Nelson, M.D., president of the American Medical Association, said during the center's opening celebration.

“Patient safety has to be much more on the minds of all of us,” Dr. Nelson said. “This is what our patients expect and our profession demands.”

Patient-centered goals of the center staff include developing better ways to disclose medical errors to patients and their families. Another goal is to identify the factors that patients consider when choosing a hospital, and how these may differ by cultural or ethnic identity, Dr. Barach explained.

“Despite our best intentions, we make mistakes,” Dr. Gallagher said. The intention of the center directors is to solve problems, not to point fingers or assign blame when a medical error occurs.

“The debriefing is really the heart of the simulation. It is where we try to make sense of what happened in the ICU or emergency room chaos.” Participants review recorded actions, discuss what happened, suggest what they would do differently in the future, and, if an error occurs, explain how they would inform a patient or family.

“At the end of the day, all this is about is changing the culture to help people to do the right thing,” Dr. Barach said.

The University of Miami added a 4-year curriculum on patient safety for medical students. The simulation challenges are designed to be relatively simple for students but are more complicated for experienced physicians, Dr. Barach said.

“The long-term goals are to get the center to be a vital part of the community,” he said.

“We want to get throughput from medical students, practicing physicians, and nurses. We also want patient safety to become part of the certification process.”

MIAMI – The blades roared overhead as the Miami-Dade rescue helicopter approached the rooftop of University of Miami/Jackson Memorial Hospital shortly after dark.

Through the rain, emergency medical technicians rushed a pregnant woman injured in a car crash on Interstate 95. Doctors delivered the distressed baby via emergency cesarean section. An ob.gyn. administered oxygen, and the hypoxic newborn's color turned from blue to pink.

But these moments of high medical drama were not real. “Give the mother a fatal heart rhythm, and let's see how they respond,” said Chris Gallagher, M.D., of the department of anesthesiology at the University of Miami. He was addressing a technician in a control room separated from the activity in the emergency room by a one-way mirror.

The large crowd attending the grand opening of the University of Miami/Jackson Memorial Hospital Center for Patient Safety gathered closer around extra video monitors that had been set up so they could watch the simulated emergency unfold.

The “bloody” actress on the gurney was deftly switched for one of the new, state-of-the-art mannequins that are kept in residence at the new center. After the crew had stabilized both the mother and baby mannequins, they gathered around a conference table on the hospital's renovated fourth floor for a debriefing of their performance.

The emergency scenario was staged as a kickoff for the first patient safety center of its kind in the United States, one that combines simulation with elements of engineering, ergonomic design, and high-tech monitoring and recording.

Akin to a flight simulator for airline pilots, the emergency care component of the Center for Patient Safety challenges physicians and other health care workers in a realistic but safe environment where no patient is harmed.

The 2,000-square-foot simulation facility will be used to provide courses to enhance clinical, communication, and teamwork skills for health care professionals at all levels of training. The simulation facility currently trains medical students and anesthesiology residents.

Courses are planned for multidisciplinary team training of residents and nurses in internal medicine, pediatrics, emergency medicine, obstetrics, and other specialties.

“It's a dream come true after 10 years,” said Paul Barach, M.D., director of the Center for Patient Safety.

The center is innovative for bringing together all of the major elements of patient safety. “I'm most proud of the integration,” said Dr. Barach, also of the department of anesthesiology at the university.

Although other institutions in the United States have some features of the program, he said, the center at the University of Miami is the only one that combines skill assessments simulation, an investigative team to debrief participants, a human factors and usability lab, and a strategy for promoting patient safety policies in Miami, the state of Florida, and, eventually, nationwide.

The center's immediate goals include developing and disseminating training programs for physicians, nurses, pharmacists, and risk managers; enhancing research on patient safety; and working with medical device companies to use better design and ergonomics to make their products safer.

Backed by an initial $5 million in funding from federal, state, and private sources, the center has 18 projects underway. (For more details, visit www.patientsafety.med.miami.edu

The patient safety center was developed with input from the university's schools of engineering, design, nursing, and business, as well as from experts outside of the university.

Dr. Barach's drive to establish the center stemmed in part from a medical error he experienced as a medical student.

“I was told to do a central line procedure, but not told how to do it. The intern just told me to do it. I was just out of the military and did not question orders,” he said. “The patient suffered a hemothorax, was intubated, went to the ICU, and she died 4 days later.”

The experience haunted him for years, he said.

Although the mannequins are the focal point in each of the five skills assessment areas–three exam rooms, an operating room, and a room that can function as an ICU, emergency room, or ward room, “the focus is not on simulation, the focus is on the patient,” John C. Nelson, M.D., president of the American Medical Association, said during the center's opening celebration.

“Patient safety has to be much more on the minds of all of us,” Dr. Nelson said. “This is what our patients expect and our profession demands.”

Patient-centered goals of the center staff include developing better ways to disclose medical errors to patients and their families. Another goal is to identify the factors that patients consider when choosing a hospital, and how these may differ by cultural or ethnic identity, Dr. Barach explained.

“Despite our best intentions, we make mistakes,” Dr. Gallagher said. The intention of the center directors is to solve problems, not to point fingers or assign blame when a medical error occurs.

“The debriefing is really the heart of the simulation. It is where we try to make sense of what happened in the ICU or emergency room chaos.” Participants review recorded actions, discuss what happened, suggest what they would do differently in the future, and, if an error occurs, explain how they would inform a patient or family.

“At the end of the day, all this is about is changing the culture to help people to do the right thing,” Dr. Barach said.

The University of Miami added a 4-year curriculum on patient safety for medical students. The simulation challenges are designed to be relatively simple for students but are more complicated for experienced physicians, Dr. Barach said.

“The long-term goals are to get the center to be a vital part of the community,” he said.

“We want to get throughput from medical students, practicing physicians, and nurses. We also want patient safety to become part of the certification process.”

SAN JUAN, P.R. — Better understanding of interactions between opioids and antiretroviral agents can improve clinical care and patient outcomes, said Elinore McCance-Katz, M.D.

“It may be that methadone is not the best opiate therapy for everyone with HIV who is opioid dependent,” Dr. McCance-Katz said at the annual meeting of the American Academy of Addiction Psychiatry.

“These drug interactions are so potent, it is important to know if there are optimal combinations of opiate therapies and HIV medications,” she added.

Through the cytochrome P-450 system, many antiretroviral agents interact with opioids, including methadone (see box), levomethadyl acetate (LAAM), and buprenorphine.

HIV drugs that induce metabolism of methadone can cause symptoms of opiate withdrawal between doses, whereas HIV drugs that inhibit such metabolism can cause opiate toxicity.

Such interactions can lead to nonadherence to antiretroviral regimens, viral resistance, and illicit drug use “in an attempt to self-medicate some of these noxious drug interactions that often go unrecognized,” said Dr. McCance-Katz, chair of the division of addiction psychiatry, Virginia Commonwealth University, Richmond.

Drug toxicities that are additive can be a risk to patients. Because of the clinically significant interactions, the Food and Drug Administration now requires methadone interaction data before approval of a new antiretroviral agent.

Researchers are assessing alternatives to methadone for HIV patients. Buprenorphine, for example, may not have the same liabilities as methadone in combination with antiretroviral therapy, she said. “I'm still looking at the data, but we don't see the toxicities with buprenorphine and LAAM that we see with methadone.”

Methadone-maintained patients using efavirenz as part of highly active antiretroviral therapy need a 50% increase in methadone level, from 80 mg/dL at baseline to 120 mg/dL, according to research by Dr. McCance-Katz. With buprenorphine, the mean 17.2-mg/dL dosage did not change when efavirenz was added. “We did not have to increase the opiate dose for anyone, and we did not have to restabilize people as a result.”

Not all of methadone's effects on HIV drugs are via cytochrome P-450 metabolism. For example, didanosine and stavudine concentrations drop to subtherapeutic levels when these drugs are taken with methadone. Methadone decreases gastrointestinal motility, and didanosine and stavudine are particularly sensitive to stomach acid.

Dr. McCance-Katz highlighted some specific interactions between methadone and agents that combat HIV:

▸Delavirdine mesylate inhibits cytochrome P-450, leading to a significant increase in methadone concentrations—the half-life is extended by almost 50%. “We would worry about accumulation,” she said. “With LAAM, we see even more dramatic effects and LAAM metabolites, which have implications for cardiac toxicity.”

▸Nevirapine is similar to delavirdine, causing a decrease of about 50% in methadone area-under-the-curve concentrations. Withdrawal symptoms can occur if methadone dosages are not increased.

▸Nelfinavir mesylate shows a “dramatic drop” in 7-day plasma levels when given with methadone. “Interestingly, we did not see withdrawal in these patients. We think that is because nelfinavir is a very good competitor for protein binding—so there was more free methadone available to protect them from opiate withdrawal,” she said.

▸Kaletra, a combination of lopinavir and ritonavir, causes methadone levels to become subtherapeutic. Dr. McCance-Katz observed withdrawal symptoms in these patients. “But we did not know if it was an effect of lopinavir, ritonavir, or both.” When ritonavir was studied alone, the nonsignificant increase in methadone level implicated lopinavir as the component interacting with methadone.

Interactions

These antiretroviral drugs were found to interact with methadone:

Abacavir

Combivir

Delavirdine

Didanosine

Efavirenz

Lopinavir

Nelfinavir

Nevirapine

Ritonavir

Saquinavir

Stavudine

Zidovudine

Source: Dr. McCance-Katz

SAN JUAN, P.R. — Better understanding of interactions between opioids and antiretroviral agents can improve clinical care and patient outcomes, said Elinore McCance-Katz, M.D.

“It may be that methadone is not the best opiate therapy for everyone with HIV who is opioid dependent,” Dr. McCance-Katz said at the annual meeting of the American Academy of Addiction Psychiatry.

“These drug interactions are so potent, it is important to know if there are optimal combinations of opiate therapies and HIV medications,” she added.

Through the cytochrome P-450 system, many antiretroviral agents interact with opioids, including methadone (see box), levomethadyl acetate (LAAM), and buprenorphine.

HIV drugs that induce metabolism of methadone can cause symptoms of opiate withdrawal between doses, whereas HIV drugs that inhibit such metabolism can cause opiate toxicity.

Such interactions can lead to nonadherence to antiretroviral regimens, viral resistance, and illicit drug use “in an attempt to self-medicate some of these noxious drug interactions that often go unrecognized,” said Dr. McCance-Katz, chair of the division of addiction psychiatry, Virginia Commonwealth University, Richmond.

Drug toxicities that are additive can be a risk to patients. Because of the clinically significant interactions, the Food and Drug Administration now requires methadone interaction data before approval of a new antiretroviral agent.

Researchers are assessing alternatives to methadone for HIV patients. Buprenorphine, for example, may not have the same liabilities as methadone in combination with antiretroviral therapy, she said. “I'm still looking at the data, but we don't see the toxicities with buprenorphine and LAAM that we see with methadone.”

Methadone-maintained patients using efavirenz as part of highly active antiretroviral therapy need a 50% increase in methadone level, from 80 mg/dL at baseline to 120 mg/dL, according to research by Dr. McCance-Katz. With buprenorphine, the mean 17.2-mg/dL dosage did not change when efavirenz was added. “We did not have to increase the opiate dose for anyone, and we did not have to restabilize people as a result.”

Not all of methadone's effects on HIV drugs are via cytochrome P-450 metabolism. For example, didanosine and stavudine concentrations drop to subtherapeutic levels when these drugs are taken with methadone. Methadone decreases gastrointestinal motility, and didanosine and stavudine are particularly sensitive to stomach acid.

Dr. McCance-Katz highlighted some specific interactions between methadone and agents that combat HIV:

▸Delavirdine mesylate inhibits cytochrome P-450, leading to a significant increase in methadone concentrations—the half-life is extended by almost 50%. “We would worry about accumulation,” she said. “With LAAM, we see even more dramatic effects and LAAM metabolites, which have implications for cardiac toxicity.”

▸Nevirapine is similar to delavirdine, causing a decrease of about 50% in methadone area-under-the-curve concentrations. Withdrawal symptoms can occur if methadone dosages are not increased.

▸Nelfinavir mesylate shows a “dramatic drop” in 7-day plasma levels when given with methadone. “Interestingly, we did not see withdrawal in these patients. We think that is because nelfinavir is a very good competitor for protein binding—so there was more free methadone available to protect them from opiate withdrawal,” she said.

▸Kaletra, a combination of lopinavir and ritonavir, causes methadone levels to become subtherapeutic. Dr. McCance-Katz observed withdrawal symptoms in these patients. “But we did not know if it was an effect of lopinavir, ritonavir, or both.” When ritonavir was studied alone, the nonsignificant increase in methadone level implicated lopinavir as the component interacting with methadone.

Interactions

These antiretroviral drugs were found to interact with methadone:

Abacavir

Combivir

Delavirdine

Didanosine

Efavirenz

Lopinavir

Nelfinavir

Nevirapine

Ritonavir

Saquinavir

Stavudine

Zidovudine

Source: Dr. McCance-Katz

SAN JUAN, P.R. — Better understanding of interactions between opioids and antiretroviral agents can improve clinical care and patient outcomes, said Elinore McCance-Katz, M.D.

“It may be that methadone is not the best opiate therapy for everyone with HIV who is opioid dependent,” Dr. McCance-Katz said at the annual meeting of the American Academy of Addiction Psychiatry.

“These drug interactions are so potent, it is important to know if there are optimal combinations of opiate therapies and HIV medications,” she added.

Through the cytochrome P-450 system, many antiretroviral agents interact with opioids, including methadone (see box), levomethadyl acetate (LAAM), and buprenorphine.

HIV drugs that induce metabolism of methadone can cause symptoms of opiate withdrawal between doses, whereas HIV drugs that inhibit such metabolism can cause opiate toxicity.

Such interactions can lead to nonadherence to antiretroviral regimens, viral resistance, and illicit drug use “in an attempt to self-medicate some of these noxious drug interactions that often go unrecognized,” said Dr. McCance-Katz, chair of the division of addiction psychiatry, Virginia Commonwealth University, Richmond.

Drug toxicities that are additive can be a risk to patients. Because of the clinically significant interactions, the Food and Drug Administration now requires methadone interaction data before approval of a new antiretroviral agent.

Researchers are assessing alternatives to methadone for HIV patients. Buprenorphine, for example, may not have the same liabilities as methadone in combination with antiretroviral therapy, she said. “I'm still looking at the data, but we don't see the toxicities with buprenorphine and LAAM that we see with methadone.”

Methadone-maintained patients using efavirenz as part of highly active antiretroviral therapy need a 50% increase in methadone level, from 80 mg/dL at baseline to 120 mg/dL, according to research by Dr. McCance-Katz. With buprenorphine, the mean 17.2-mg/dL dosage did not change when efavirenz was added. “We did not have to increase the opiate dose for anyone, and we did not have to restabilize people as a result.”

Not all of methadone's effects on HIV drugs are via cytochrome P-450 metabolism. For example, didanosine and stavudine concentrations drop to subtherapeutic levels when these drugs are taken with methadone. Methadone decreases gastrointestinal motility, and didanosine and stavudine are particularly sensitive to stomach acid.

Dr. McCance-Katz highlighted some specific interactions between methadone and agents that combat HIV:

▸Delavirdine mesylate inhibits cytochrome P-450, leading to a significant increase in methadone concentrations—the half-life is extended by almost 50%. “We would worry about accumulation,” she said. “With LAAM, we see even more dramatic effects and LAAM metabolites, which have implications for cardiac toxicity.”

▸Nevirapine is similar to delavirdine, causing a decrease of about 50% in methadone area-under-the-curve concentrations. Withdrawal symptoms can occur if methadone dosages are not increased.

▸Nelfinavir mesylate shows a “dramatic drop” in 7-day plasma levels when given with methadone. “Interestingly, we did not see withdrawal in these patients. We think that is because nelfinavir is a very good competitor for protein binding—so there was more free methadone available to protect them from opiate withdrawal,” she said.

▸Kaletra, a combination of lopinavir and ritonavir, causes methadone levels to become subtherapeutic. Dr. McCance-Katz observed withdrawal symptoms in these patients. “But we did not know if it was an effect of lopinavir, ritonavir, or both.” When ritonavir was studied alone, the nonsignificant increase in methadone level implicated lopinavir as the component interacting with methadone.

Interactions

These antiretroviral drugs were found to interact with methadone:

Abacavir

Combivir

Delavirdine

Didanosine

Efavirenz

Lopinavir

Nelfinavir

Nevirapine

Ritonavir

Saquinavir

Stavudine

Zidovudine

Source: Dr. McCance-Katz

ORLANDO, FLA. — Mesotherapy targets and reduces spot fat without surgery and offers several advantages, compared with liposuction, said Gerald M. Parker, D.O., at an obesity symposium sponsored by the American Society of Bariatric Physicians.

Originally developed to manage localized pain, mesotherapy has aesthetic possibilities that have gained recognition in the past 2-3 years, said Dr. Parker. "It is now being touted as the latest breakthrough in body sculpting, cellulite reduction, and spot fat reduction," he said.

Proper patient selection is paramount. "This is a new therapy in the United States. If you get into this, make sure you are doing it on the right candidates," Dr. Parker emphasized. Appropriate candidates are 15-30 pounds overweight with small or moderate areas of fat. Patients who are more overweight than that will not get the same results, said Dr. Parker, a bariatric physician in private practice in Dallas.

Blood work is recommended before starting. A physician injects various substances into the skin's mesoderm layer—which gives mesotherapy its name—including vitamins, minerals, amino acids, essential phospholipids, homeopathic remedies, or medication. The selected substances target fat cell surface receptors and lyse the cell walls.

"Just about anywhere you have fat, you can treat it," Dr. Parker said. Generally, patients request 4-6 treatment sessions. Mesotherapy can be used for the abdominals, legs, inner thighs, arms, and cellulite.

"Cellulite is a big area because there are no effective treatments. Cellulite is even a problem in younger women who are not overweight," he said.

Another application is treatment of lower eyelid fat pads. In a study at the University of California at Los Angeles, 80% of 13 patients injected with the lecithin-derived phospholipid phosphatidylcholine showed improvement (Dermatol. Surg. 2004;30:422-7). Results after three to five sessions indicate that mesotherapy may be a good alternative to blepharoplasty surgery, according to the authors.

In an unpublished study conducted for the American College of Medical Meso-Lipotherapy, Dr. Parker treated the abdominal area of 50 patients in four sessions. After 6 weeks, the average reduction in waist circumference was 3.34 inches, although there was a "pretty typical" range of 1-8 inches.

"I tell my patients they can expect to lose about a quarter inch per session if they do nothing else and half an inch with diet and exercise," Dr. Parker said. "We've seen up to 2 inches to 3 inches at a time—striking results—if people are very aggressive."

Researchers agree that to maintain results, patients treated with mesotherapy need to eat properly and exercise. "About the only people who do not get a response to mesotherapy are those who go out and do everything they shouldn't," Dr. Parker said.

Unlike liposuction, mesotherapy carries no risk of postprocedure "denting" if a patient gains weight, and almost no risk of infection if good hygiene practices are followed. Patients typically experience some minor swelling.

ORLANDO, FLA. — Mesotherapy targets and reduces spot fat without surgery and offers several advantages, compared with liposuction, said Gerald M. Parker, D.O., at an obesity symposium sponsored by the American Society of Bariatric Physicians.

Originally developed to manage localized pain, mesotherapy has aesthetic possibilities that have gained recognition in the past 2-3 years, said Dr. Parker. "It is now being touted as the latest breakthrough in body sculpting, cellulite reduction, and spot fat reduction," he said.

Proper patient selection is paramount. "This is a new therapy in the United States. If you get into this, make sure you are doing it on the right candidates," Dr. Parker emphasized. Appropriate candidates are 15-30 pounds overweight with small or moderate areas of fat. Patients who are more overweight than that will not get the same results, said Dr. Parker, a bariatric physician in private practice in Dallas.

Blood work is recommended before starting. A physician injects various substances into the skin's mesoderm layer—which gives mesotherapy its name—including vitamins, minerals, amino acids, essential phospholipids, homeopathic remedies, or medication. The selected substances target fat cell surface receptors and lyse the cell walls.

"Just about anywhere you have fat, you can treat it," Dr. Parker said. Generally, patients request 4-6 treatment sessions. Mesotherapy can be used for the abdominals, legs, inner thighs, arms, and cellulite.

"Cellulite is a big area because there are no effective treatments. Cellulite is even a problem in younger women who are not overweight," he said.

Another application is treatment of lower eyelid fat pads. In a study at the University of California at Los Angeles, 80% of 13 patients injected with the lecithin-derived phospholipid phosphatidylcholine showed improvement (Dermatol. Surg. 2004;30:422-7). Results after three to five sessions indicate that mesotherapy may be a good alternative to blepharoplasty surgery, according to the authors.

In an unpublished study conducted for the American College of Medical Meso-Lipotherapy, Dr. Parker treated the abdominal area of 50 patients in four sessions. After 6 weeks, the average reduction in waist circumference was 3.34 inches, although there was a "pretty typical" range of 1-8 inches.

"I tell my patients they can expect to lose about a quarter inch per session if they do nothing else and half an inch with diet and exercise," Dr. Parker said. "We've seen up to 2 inches to 3 inches at a time—striking results—if people are very aggressive."

Researchers agree that to maintain results, patients treated with mesotherapy need to eat properly and exercise. "About the only people who do not get a response to mesotherapy are those who go out and do everything they shouldn't," Dr. Parker said.

Unlike liposuction, mesotherapy carries no risk of postprocedure "denting" if a patient gains weight, and almost no risk of infection if good hygiene practices are followed. Patients typically experience some minor swelling.

ORLANDO, FLA. — Mesotherapy targets and reduces spot fat without surgery and offers several advantages, compared with liposuction, said Gerald M. Parker, D.O., at an obesity symposium sponsored by the American Society of Bariatric Physicians.

Originally developed to manage localized pain, mesotherapy has aesthetic possibilities that have gained recognition in the past 2-3 years, said Dr. Parker. "It is now being touted as the latest breakthrough in body sculpting, cellulite reduction, and spot fat reduction," he said.

Proper patient selection is paramount. "This is a new therapy in the United States. If you get into this, make sure you are doing it on the right candidates," Dr. Parker emphasized. Appropriate candidates are 15-30 pounds overweight with small or moderate areas of fat. Patients who are more overweight than that will not get the same results, said Dr. Parker, a bariatric physician in private practice in Dallas.

Blood work is recommended before starting. A physician injects various substances into the skin's mesoderm layer—which gives mesotherapy its name—including vitamins, minerals, amino acids, essential phospholipids, homeopathic remedies, or medication. The selected substances target fat cell surface receptors and lyse the cell walls.

"Just about anywhere you have fat, you can treat it," Dr. Parker said. Generally, patients request 4-6 treatment sessions. Mesotherapy can be used for the abdominals, legs, inner thighs, arms, and cellulite.

"Cellulite is a big area because there are no effective treatments. Cellulite is even a problem in younger women who are not overweight," he said.

Another application is treatment of lower eyelid fat pads. In a study at the University of California at Los Angeles, 80% of 13 patients injected with the lecithin-derived phospholipid phosphatidylcholine showed improvement (Dermatol. Surg. 2004;30:422-7). Results after three to five sessions indicate that mesotherapy may be a good alternative to blepharoplasty surgery, according to the authors.

In an unpublished study conducted for the American College of Medical Meso-Lipotherapy, Dr. Parker treated the abdominal area of 50 patients in four sessions. After 6 weeks, the average reduction in waist circumference was 3.34 inches, although there was a "pretty typical" range of 1-8 inches.

"I tell my patients they can expect to lose about a quarter inch per session if they do nothing else and half an inch with diet and exercise," Dr. Parker said. "We've seen up to 2 inches to 3 inches at a time—striking results—if people are very aggressive."

Researchers agree that to maintain results, patients treated with mesotherapy need to eat properly and exercise. "About the only people who do not get a response to mesotherapy are those who go out and do everything they shouldn't," Dr. Parker said.

Unlike liposuction, mesotherapy carries no risk of postprocedure "denting" if a patient gains weight, and almost no risk of infection if good hygiene practices are followed. Patients typically experience some minor swelling.

MIAMI — The blades roared overhead as the Miami-Dade rescue helicopter approached the rooftop of University of Miami/Jackson Memorial Hospital shortly after dark.

Through the rain, emergency medical technicians rushed a pregnant woman injured in a car crash on Interstate 95. Doctors delivered the distressed baby via emergency cesarean section. An ob.gyn. administered oxygen, and the hypoxic newborn's color turned from blue to pink.

But these moments of high medical drama were not real. “Give the mother a fatal heart rhythm, and let's see how they respond,” said Chris Gallagher, M.D., of the department of anesthesiology at the University of Miami. He was addressing a technician in a control room separated from the activity in the emergency room by a one-way mirror.

The large crowd attending the grand opening of the University of Miami/Jackson Memorial Hospital Center for Patient Safety gathered closer around extra video monitors that had been set up so they could watch the simulated emergency unfold. The “bloody” actress on the gurney was deftly switched for one of the new, state-of-the-art mannequins in residence at the new center. After the crew had stabilized both the mother and baby mannequins, they gathered around a conference table on the hospital's renovated fourth floor for a debriefing of their performance.

The emergency scenario was staged as a kickoff for the first patient safety center of its kind in the United States, one that combines simulation with elements of engineering, ergonomic design, and high-tech monitoring and recording. Akin to a flight simulator for airline pilots, the emergency care component of the Center for Patient Safety challenges physicians and other health care workers in a realistic but safe environment where no patient is harmed.

The 2,000-square-foot simulation facility will be used to provide courses to enhance clinical, communication, and teamwork skills for health care professionals at all levels of training. The simulation facility currently trains medical students and anesthesiology residents. Courses are planned for multidisciplinary team training of residents and nurses in internal medicine, pediatrics, emergency medicine, obstetrics, and other specialties.

“It's a dream come true after 10 years,” said Paul Barach, M.D., director of the Center for Patient Safety.

The center is innovative for bringing together all of the major elements of patient safety. “I'm most proud of the integration,” said Dr. Barach, also of the department of anesthesiology at the university.

Although other institutions in the United States have some features of the program, he said, only the University of Miami center combines skill assessments simulation; an investigative team to debrief participants; a human factors and usability lab; and a strategy for promoting patient safety policies in Miami, the state of Florida, and, eventually, nationwide.

The center's immediate goals include developing and disseminating training programs for physicians, nurses, pharmacists, and risk managers; enhancing research on patient safety; and working with medical device companies to use better design and ergonomics to make their products safer.

Backed by an initial $5 million in funds from federal, state, and private sources, the center has 18 projects underway. (For more details, visit www.patientsafety.med.miami.edu

Dr. Barach's drive to establish the center stemmed in part from a medical error he experienced as a medical student. “I was told to do a central line procedure, but not told how to do it. The intern just told me to do it. I was just out of the military and did not question orders,” he said. “The patient suffered a hemothorax, was intubated, went to the ICU, and she died 4 days later.” The experience “haunted me for years.”

Although the mannequins are the focal point in each of the five skills assessment areas—three exam rooms, an operating room, and a room that can function as an ICU, emergency room, or ward room, “the focus is not on simulation, the focus is on the patient,” John C. Nelson, M.D., president of the American Medical Association, said during the opening celebration.

“Patient safety has to be much more on the minds of all of us,” Dr. Nelson said. “This is what our patients expect and our profession demands.”

Patient-centered goals of the center staff include developing better ways to disclose medical errors to patients and their families. Another goal is to identify the factors that patients consider when choosing a hospital, and how these may differ by cultural or ethnic identity, Dr. Barach explained.

“Despite our best intentions, we make mistakes,” Dr. Gallagher said. The intention of the center directors is to solve problems, not to point fingers or assign blame when a medical error occurs. “The debriefing is really the heart of the simulation. It is where we try to make sense of what happened in the ICU or emergency room chaos.” Participants review recorded actions, discuss what happened, suggest what they would do differently in the future, and, if an error occurs, explain how they would inform a patient or family.

“At the end of the day, all this is about is changing the culture to help people to do the right thing,” Dr. Barach said.

The University of Miami added a 4-year curriculum on patient safety for medical students. The simulation challenges are designed to be relatively simple for students but are more complicated for experienced physicians, Dr. Barach said. “The long-term goals are to get the center to be a vital part of the community. We want to get throughput from medical students, practicing physicians, and nurses. We also want patient safety to become part of the certification process.”

MIAMI — The blades roared overhead as the Miami-Dade rescue helicopter approached the rooftop of University of Miami/Jackson Memorial Hospital shortly after dark.

Through the rain, emergency medical technicians rushed a pregnant woman injured in a car crash on Interstate 95. Doctors delivered the distressed baby via emergency cesarean section. An ob.gyn. administered oxygen, and the hypoxic newborn's color turned from blue to pink.

But these moments of high medical drama were not real. “Give the mother a fatal heart rhythm, and let's see how they respond,” said Chris Gallagher, M.D., of the department of anesthesiology at the University of Miami. He was addressing a technician in a control room separated from the activity in the emergency room by a one-way mirror.

The large crowd attending the grand opening of the University of Miami/Jackson Memorial Hospital Center for Patient Safety gathered closer around extra video monitors that had been set up so they could watch the simulated emergency unfold. The “bloody” actress on the gurney was deftly switched for one of the new, state-of-the-art mannequins in residence at the new center. After the crew had stabilized both the mother and baby mannequins, they gathered around a conference table on the hospital's renovated fourth floor for a debriefing of their performance.

The emergency scenario was staged as a kickoff for the first patient safety center of its kind in the United States, one that combines simulation with elements of engineering, ergonomic design, and high-tech monitoring and recording. Akin to a flight simulator for airline pilots, the emergency care component of the Center for Patient Safety challenges physicians and other health care workers in a realistic but safe environment where no patient is harmed.

The 2,000-square-foot simulation facility will be used to provide courses to enhance clinical, communication, and teamwork skills for health care professionals at all levels of training. The simulation facility currently trains medical students and anesthesiology residents. Courses are planned for multidisciplinary team training of residents and nurses in internal medicine, pediatrics, emergency medicine, obstetrics, and other specialties.

“It's a dream come true after 10 years,” said Paul Barach, M.D., director of the Center for Patient Safety.

The center is innovative for bringing together all of the major elements of patient safety. “I'm most proud of the integration,” said Dr. Barach, also of the department of anesthesiology at the university.

Although other institutions in the United States have some features of the program, he said, only the University of Miami center combines skill assessments simulation; an investigative team to debrief participants; a human factors and usability lab; and a strategy for promoting patient safety policies in Miami, the state of Florida, and, eventually, nationwide.

The center's immediate goals include developing and disseminating training programs for physicians, nurses, pharmacists, and risk managers; enhancing research on patient safety; and working with medical device companies to use better design and ergonomics to make their products safer.

Backed by an initial $5 million in funds from federal, state, and private sources, the center has 18 projects underway. (For more details, visit www.patientsafety.med.miami.edu

Dr. Barach's drive to establish the center stemmed in part from a medical error he experienced as a medical student. “I was told to do a central line procedure, but not told how to do it. The intern just told me to do it. I was just out of the military and did not question orders,” he said. “The patient suffered a hemothorax, was intubated, went to the ICU, and she died 4 days later.” The experience “haunted me for years.”

Although the mannequins are the focal point in each of the five skills assessment areas—three exam rooms, an operating room, and a room that can function as an ICU, emergency room, or ward room, “the focus is not on simulation, the focus is on the patient,” John C. Nelson, M.D., president of the American Medical Association, said during the opening celebration.

“Patient safety has to be much more on the minds of all of us,” Dr. Nelson said. “This is what our patients expect and our profession demands.”

Patient-centered goals of the center staff include developing better ways to disclose medical errors to patients and their families. Another goal is to identify the factors that patients consider when choosing a hospital, and how these may differ by cultural or ethnic identity, Dr. Barach explained.

“Despite our best intentions, we make mistakes,” Dr. Gallagher said. The intention of the center directors is to solve problems, not to point fingers or assign blame when a medical error occurs. “The debriefing is really the heart of the simulation. It is where we try to make sense of what happened in the ICU or emergency room chaos.” Participants review recorded actions, discuss what happened, suggest what they would do differently in the future, and, if an error occurs, explain how they would inform a patient or family.

“At the end of the day, all this is about is changing the culture to help people to do the right thing,” Dr. Barach said.

The University of Miami added a 4-year curriculum on patient safety for medical students. The simulation challenges are designed to be relatively simple for students but are more complicated for experienced physicians, Dr. Barach said. “The long-term goals are to get the center to be a vital part of the community. We want to get throughput from medical students, practicing physicians, and nurses. We also want patient safety to become part of the certification process.”

MIAMI — The blades roared overhead as the Miami-Dade rescue helicopter approached the rooftop of University of Miami/Jackson Memorial Hospital shortly after dark.

Through the rain, emergency medical technicians rushed a pregnant woman injured in a car crash on Interstate 95. Doctors delivered the distressed baby via emergency cesarean section. An ob.gyn. administered oxygen, and the hypoxic newborn's color turned from blue to pink.

But these moments of high medical drama were not real. “Give the mother a fatal heart rhythm, and let's see how they respond,” said Chris Gallagher, M.D., of the department of anesthesiology at the University of Miami. He was addressing a technician in a control room separated from the activity in the emergency room by a one-way mirror.

The large crowd attending the grand opening of the University of Miami/Jackson Memorial Hospital Center for Patient Safety gathered closer around extra video monitors that had been set up so they could watch the simulated emergency unfold. The “bloody” actress on the gurney was deftly switched for one of the new, state-of-the-art mannequins in residence at the new center. After the crew had stabilized both the mother and baby mannequins, they gathered around a conference table on the hospital's renovated fourth floor for a debriefing of their performance.

The emergency scenario was staged as a kickoff for the first patient safety center of its kind in the United States, one that combines simulation with elements of engineering, ergonomic design, and high-tech monitoring and recording. Akin to a flight simulator for airline pilots, the emergency care component of the Center for Patient Safety challenges physicians and other health care workers in a realistic but safe environment where no patient is harmed.

The 2,000-square-foot simulation facility will be used to provide courses to enhance clinical, communication, and teamwork skills for health care professionals at all levels of training. The simulation facility currently trains medical students and anesthesiology residents. Courses are planned for multidisciplinary team training of residents and nurses in internal medicine, pediatrics, emergency medicine, obstetrics, and other specialties.

“It's a dream come true after 10 years,” said Paul Barach, M.D., director of the Center for Patient Safety.

The center is innovative for bringing together all of the major elements of patient safety. “I'm most proud of the integration,” said Dr. Barach, also of the department of anesthesiology at the university.

Although other institutions in the United States have some features of the program, he said, only the University of Miami center combines skill assessments simulation; an investigative team to debrief participants; a human factors and usability lab; and a strategy for promoting patient safety policies in Miami, the state of Florida, and, eventually, nationwide.

The center's immediate goals include developing and disseminating training programs for physicians, nurses, pharmacists, and risk managers; enhancing research on patient safety; and working with medical device companies to use better design and ergonomics to make their products safer.

Backed by an initial $5 million in funds from federal, state, and private sources, the center has 18 projects underway. (For more details, visit www.patientsafety.med.miami.edu

Dr. Barach's drive to establish the center stemmed in part from a medical error he experienced as a medical student. “I was told to do a central line procedure, but not told how to do it. The intern just told me to do it. I was just out of the military and did not question orders,” he said. “The patient suffered a hemothorax, was intubated, went to the ICU, and she died 4 days later.” The experience “haunted me for years.”

Although the mannequins are the focal point in each of the five skills assessment areas—three exam rooms, an operating room, and a room that can function as an ICU, emergency room, or ward room, “the focus is not on simulation, the focus is on the patient,” John C. Nelson, M.D., president of the American Medical Association, said during the opening celebration.

“Patient safety has to be much more on the minds of all of us,” Dr. Nelson said. “This is what our patients expect and our profession demands.”

Patient-centered goals of the center staff include developing better ways to disclose medical errors to patients and their families. Another goal is to identify the factors that patients consider when choosing a hospital, and how these may differ by cultural or ethnic identity, Dr. Barach explained.

“Despite our best intentions, we make mistakes,” Dr. Gallagher said. The intention of the center directors is to solve problems, not to point fingers or assign blame when a medical error occurs. “The debriefing is really the heart of the simulation. It is where we try to make sense of what happened in the ICU or emergency room chaos.” Participants review recorded actions, discuss what happened, suggest what they would do differently in the future, and, if an error occurs, explain how they would inform a patient or family.

“At the end of the day, all this is about is changing the culture to help people to do the right thing,” Dr. Barach said.

The University of Miami added a 4-year curriculum on patient safety for medical students. The simulation challenges are designed to be relatively simple for students but are more complicated for experienced physicians, Dr. Barach said. “The long-term goals are to get the center to be a vital part of the community. We want to get throughput from medical students, practicing physicians, and nurses. We also want patient safety to become part of the certification process.”

MIAMI BEACH, FLA. — Accelerated immunizations for children can optimize disease prevention before international travel, Elizabeth D. Barnett, M.D., said at the annual meeting of the American Society of Tropical Medicine and Hygiene.

Hepatitis A, typhoid fever, yellow fever, Japanese encephalitis, meningococcal infection, and rabies infection are some of the leading concerns for pediatric travelers, according to Dr. Barnett, director of the International Clinic, Maxwell Finland Laboratory for Infectious Diseases, Boston Medical Center.

The good news is that most traveling children have already received vaccines for hepatitis B and pneumococcal disease.

The health and age of the infant or child, the endemic diseases in destination countries, and risk-benefit considerations for each vaccination are all important considerations, she said. For example, efficacy of polysaccharide vaccines will be limited until age 2 years because of impaired T-cell function. In addition, maternal antibodies can impair response to some vaccines in very young infants, such as the measles, mumps, and rubella (MMR) and hepatitis A vaccines. “Balance the lower age limit of the vaccine with risk of disease and vaccine efficacy.”

If travel to a measles-endemic area is planned, consider giving MMR beginning at 6 months of age. If the patient is traveling to a region where a polio outbreak is possible, he or she should receive a full course of polio vaccination beforehand.

Dr. Barnett made some specific recommendations:

▸ Hepatitis A. Hepatitis A vaccine should be given 2–4 weeks prior to departure for children traveling to all international destinations except Australia, Canada, Japan, New Zea-land, Western Europe, and Scandinavia. Children at least 1 year old can receive the vaccine; the only option for younger travelers is immune globulin. “If the time to departure is short, consider giving immune globulin and vaccine at the same time as MMR or varicella vaccines at different sites,” Dr. Barnett said. Immune globulin may impair vaccine activity, so the ideal situation is to give the vaccine first, followed at least 2 weeks later by the immune globulin.

“The benefit really outweighs the risks with hepatitis A vaccine,” Dr. Barnett said.

▸ Typhoid. Vaccination is indicated for, not by length of trip, but by travel to areas where exposure to contaminated food or water is possible. The vaccine's efficacy is limited compared to hepatitis A, Dr. Barnett said. “We generally tell patients the efficacy is 65%–85%.”

For infants under 2 years, exposure should be avoided; for ages 2–5 years, limiting exposure and giving a polysaccharide vaccine are recommended; and for children 6 years and older, limiting exposure and giving the parenteral oral polysaccharide vaccine are recommended. Adverse events with the parenteral vaccine include local reactions (7%), headache (1.5%–3%) and fever (0%–1%).

Dr. Barnett said, “In most settings, the benefit for typhoid vaccine is there, limited by incomplete vaccine efficacy.”

▸ Yellow Fever. Although the risk is low (0.4 to 4.3 cases per million U.S. travelers to endemic areas) and is only present in Africa and South America, the vaccine is very efficacious, with a single vaccination usually providing lifetime coverage.

“Encephalitis is a rare adverse event following yellow fever vaccine, occurring primarily in infants,” Dr. Barnett said. “The vaccine, therefore, is absolutely contraindicated in infants under 6 months.”

“The bottom line is, those who are at risk for yellow fever, going to high transmission areas, and who cannot guarantee mosquito protection, should receive yellow fever vaccine unless there are specific contraindications,” Dr. Barnett said.

▸ Japanese Encephalitis. There is an effective vaccine, and it is indicated for some travel to higher-risk areas, Dr. Barnett said. “We have to again balance risks and benefits.” The risk is greater in rural farming areas, during transmission season, and during outbreaks.

▸ Meningococcal Infection. Sub-Saharan Africa has frequent epidemics and outbreaks. “The overall risk of disease for travelers to sub-Saharan Africa is very low, but the [polysaccharide] vaccine is safe, effective in children over 2, and offers some protection at home,” she said. A conjugate vaccine, which can be used in children under 2 years, has recently been approved by the FDA. (See related story below.)

▸ Rabies. Although the benefits of prophylaxis are greatest for travel to high-risk areas and areas far from medical care, and for travel of long duration, “I believe we should be discussing prevention with all families traveling to a destination that is not rabies-free,” Dr. Barnett said.

It is very important to tell families that additional doses are required after exposure. “We call it pre-exposure prophylaxis, we do not call it a vaccine, because medical care should still be sought if [a person is] bitten,” she emphasized.

MIAMI BEACH, FLA. — Accelerated immunizations for children can optimize disease prevention before international travel, Elizabeth D. Barnett, M.D., said at the annual meeting of the American Society of Tropical Medicine and Hygiene.

Hepatitis A, typhoid fever, yellow fever, Japanese encephalitis, meningococcal infection, and rabies infection are some of the leading concerns for pediatric travelers, according to Dr. Barnett, director of the International Clinic, Maxwell Finland Laboratory for Infectious Diseases, Boston Medical Center.

The good news is that most traveling children have already received vaccines for hepatitis B and pneumococcal disease.

The health and age of the infant or child, the endemic diseases in destination countries, and risk-benefit considerations for each vaccination are all important considerations, she said. For example, efficacy of polysaccharide vaccines will be limited until age 2 years because of impaired T-cell function. In addition, maternal antibodies can impair response to some vaccines in very young infants, such as the measles, mumps, and rubella (MMR) and hepatitis A vaccines. “Balance the lower age limit of the vaccine with risk of disease and vaccine efficacy.”

If travel to a measles-endemic area is planned, consider giving MMR beginning at 6 months of age. If the patient is traveling to a region where a polio outbreak is possible, he or she should receive a full course of polio vaccination beforehand.

Dr. Barnett made some specific recommendations:

▸ Hepatitis A. Hepatitis A vaccine should be given 2–4 weeks prior to departure for children traveling to all international destinations except Australia, Canada, Japan, New Zea-land, Western Europe, and Scandinavia. Children at least 1 year old can receive the vaccine; the only option for younger travelers is immune globulin. “If the time to departure is short, consider giving immune globulin and vaccine at the same time as MMR or varicella vaccines at different sites,” Dr. Barnett said. Immune globulin may impair vaccine activity, so the ideal situation is to give the vaccine first, followed at least 2 weeks later by the immune globulin.

“The benefit really outweighs the risks with hepatitis A vaccine,” Dr. Barnett said.

▸ Typhoid. Vaccination is indicated for, not by length of trip, but by travel to areas where exposure to contaminated food or water is possible. The vaccine's efficacy is limited compared to hepatitis A, Dr. Barnett said. “We generally tell patients the efficacy is 65%–85%.”

For infants under 2 years, exposure should be avoided; for ages 2–5 years, limiting exposure and giving a polysaccharide vaccine are recommended; and for children 6 years and older, limiting exposure and giving the parenteral oral polysaccharide vaccine are recommended. Adverse events with the parenteral vaccine include local reactions (7%), headache (1.5%–3%) and fever (0%–1%).

Dr. Barnett said, “In most settings, the benefit for typhoid vaccine is there, limited by incomplete vaccine efficacy.”

▸ Yellow Fever. Although the risk is low (0.4 to 4.3 cases per million U.S. travelers to endemic areas) and is only present in Africa and South America, the vaccine is very efficacious, with a single vaccination usually providing lifetime coverage.

“Encephalitis is a rare adverse event following yellow fever vaccine, occurring primarily in infants,” Dr. Barnett said. “The vaccine, therefore, is absolutely contraindicated in infants under 6 months.”

“The bottom line is, those who are at risk for yellow fever, going to high transmission areas, and who cannot guarantee mosquito protection, should receive yellow fever vaccine unless there are specific contraindications,” Dr. Barnett said.

▸ Japanese Encephalitis. There is an effective vaccine, and it is indicated for some travel to higher-risk areas, Dr. Barnett said. “We have to again balance risks and benefits.” The risk is greater in rural farming areas, during transmission season, and during outbreaks.

▸ Meningococcal Infection. Sub-Saharan Africa has frequent epidemics and outbreaks. “The overall risk of disease for travelers to sub-Saharan Africa is very low, but the [polysaccharide] vaccine is safe, effective in children over 2, and offers some protection at home,” she said. A conjugate vaccine, which can be used in children under 2 years, has recently been approved by the FDA. (See related story below.)

▸ Rabies. Although the benefits of prophylaxis are greatest for travel to high-risk areas and areas far from medical care, and for travel of long duration, “I believe we should be discussing prevention with all families traveling to a destination that is not rabies-free,” Dr. Barnett said.

It is very important to tell families that additional doses are required after exposure. “We call it pre-exposure prophylaxis, we do not call it a vaccine, because medical care should still be sought if [a person is] bitten,” she emphasized.

MIAMI BEACH, FLA. — Accelerated immunizations for children can optimize disease prevention before international travel, Elizabeth D. Barnett, M.D., said at the annual meeting of the American Society of Tropical Medicine and Hygiene.

Hepatitis A, typhoid fever, yellow fever, Japanese encephalitis, meningococcal infection, and rabies infection are some of the leading concerns for pediatric travelers, according to Dr. Barnett, director of the International Clinic, Maxwell Finland Laboratory for Infectious Diseases, Boston Medical Center.

The good news is that most traveling children have already received vaccines for hepatitis B and pneumococcal disease.

The health and age of the infant or child, the endemic diseases in destination countries, and risk-benefit considerations for each vaccination are all important considerations, she said. For example, efficacy of polysaccharide vaccines will be limited until age 2 years because of impaired T-cell function. In addition, maternal antibodies can impair response to some vaccines in very young infants, such as the measles, mumps, and rubella (MMR) and hepatitis A vaccines. “Balance the lower age limit of the vaccine with risk of disease and vaccine efficacy.”

If travel to a measles-endemic area is planned, consider giving MMR beginning at 6 months of age. If the patient is traveling to a region where a polio outbreak is possible, he or she should receive a full course of polio vaccination beforehand.

Dr. Barnett made some specific recommendations:

▸ Hepatitis A. Hepatitis A vaccine should be given 2–4 weeks prior to departure for children traveling to all international destinations except Australia, Canada, Japan, New Zea-land, Western Europe, and Scandinavia. Children at least 1 year old can receive the vaccine; the only option for younger travelers is immune globulin. “If the time to departure is short, consider giving immune globulin and vaccine at the same time as MMR or varicella vaccines at different sites,” Dr. Barnett said. Immune globulin may impair vaccine activity, so the ideal situation is to give the vaccine first, followed at least 2 weeks later by the immune globulin.

“The benefit really outweighs the risks with hepatitis A vaccine,” Dr. Barnett said.

▸ Typhoid. Vaccination is indicated for, not by length of trip, but by travel to areas where exposure to contaminated food or water is possible. The vaccine's efficacy is limited compared to hepatitis A, Dr. Barnett said. “We generally tell patients the efficacy is 65%–85%.”

For infants under 2 years, exposure should be avoided; for ages 2–5 years, limiting exposure and giving a polysaccharide vaccine are recommended; and for children 6 years and older, limiting exposure and giving the parenteral oral polysaccharide vaccine are recommended. Adverse events with the parenteral vaccine include local reactions (7%), headache (1.5%–3%) and fever (0%–1%).

Dr. Barnett said, “In most settings, the benefit for typhoid vaccine is there, limited by incomplete vaccine efficacy.”

▸ Yellow Fever. Although the risk is low (0.4 to 4.3 cases per million U.S. travelers to endemic areas) and is only present in Africa and South America, the vaccine is very efficacious, with a single vaccination usually providing lifetime coverage.

“Encephalitis is a rare adverse event following yellow fever vaccine, occurring primarily in infants,” Dr. Barnett said. “The vaccine, therefore, is absolutely contraindicated in infants under 6 months.”

“The bottom line is, those who are at risk for yellow fever, going to high transmission areas, and who cannot guarantee mosquito protection, should receive yellow fever vaccine unless there are specific contraindications,” Dr. Barnett said.

▸ Japanese Encephalitis. There is an effective vaccine, and it is indicated for some travel to higher-risk areas, Dr. Barnett said. “We have to again balance risks and benefits.” The risk is greater in rural farming areas, during transmission season, and during outbreaks.

▸ Meningococcal Infection. Sub-Saharan Africa has frequent epidemics and outbreaks. “The overall risk of disease for travelers to sub-Saharan Africa is very low, but the [polysaccharide] vaccine is safe, effective in children over 2, and offers some protection at home,” she said. A conjugate vaccine, which can be used in children under 2 years, has recently been approved by the FDA. (See related story below.)

▸ Rabies. Although the benefits of prophylaxis are greatest for travel to high-risk areas and areas far from medical care, and for travel of long duration, “I believe we should be discussing prevention with all families traveling to a destination that is not rabies-free,” Dr. Barnett said.

It is very important to tell families that additional doses are required after exposure. “We call it pre-exposure prophylaxis, we do not call it a vaccine, because medical care should still be sought if [a person is] bitten,” she emphasized.

MIAMI BEACH, FLA. — Want to confirm a suspected case of malaria?

You can e-mail a digital image to the Centers for Disease Control and Prevention for telediagnosis.

Then, if your patient requires treatment for malaria, you can download guidelines for treatment from its new malaria Web site, Phuc Nguyen-Dinh, M.D., said at the annual meeting of the American Society of Tropical Medicine & Hygiene.

In less than 1 year, the CDC's online malaria initiative (www.cdc.gov/malaria

Because malaria is relatively rare in the United States, with an estimated 1,200 cases identified per year, clinicians often need assistance in making the diagnosis and deciding on the treatment.

To that end, the CDC offers malaria publications, diagnostic reference services, and training seminars for laboratory personnel.

“Now information is downloadable from the Web site. We believe it is more accurate to print the guidelines than to get information over the telephone. Plus, with the Web site we can update the information as needed,” said Dr. Nguyen-Dinh, medical officer in the division of parasitic diseases at the Centers for Disease Control and Prevention, Atlanta.

The response to the Web site has been positive, Dr. Nguyen-Dinh said. The clinical guidelines are especially useful, according to 430 physicians surveyed through the Infectious Diseases Society of America's Emerging Infections Network.

The Web site features prevention information, with a link to the CDC's travelers' information site. It also features interactive training for recognition of malaria, including a quiz, sample images, and case studies.

“We know there is a need in the United States for better diagnosis,” said Stephanie Johnson, who is a CDC researcher in the Division of Parasitic Diseases.

In 2002–2003, the CDC received 188 requests for telediagnosis, of which 79 were for suspected malaria. If the telediagnosis is malaria, the CDC requests the sender submit samples for verification.

Health care providers can e-mail images of other suspected parasitic infections to the CDC's Laboratory Identification of Parasites of Public Health Concern program (www.dpd.cdc.gov/dpdx

The Centers for Disease Control and Prevention's malaria hotline, 770-488-7788, operates Monday through Friday, 8 a.m. to 4:30 p.m. EST; the after-hours emergency number is 770-488-7100.

MIAMI BEACH, FLA. — Want to confirm a suspected case of malaria?

You can e-mail a digital image to the Centers for Disease Control and Prevention for telediagnosis.

Then, if your patient requires treatment for malaria, you can download guidelines for treatment from its new malaria Web site, Phuc Nguyen-Dinh, M.D., said at the annual meeting of the American Society of Tropical Medicine & Hygiene.

In less than 1 year, the CDC's online malaria initiative (www.cdc.gov/malaria

Because malaria is relatively rare in the United States, with an estimated 1,200 cases identified per year, clinicians often need assistance in making the diagnosis and deciding on the treatment.

To that end, the CDC offers malaria publications, diagnostic reference services, and training seminars for laboratory personnel.

“Now information is downloadable from the Web site. We believe it is more accurate to print the guidelines than to get information over the telephone. Plus, with the Web site we can update the information as needed,” said Dr. Nguyen-Dinh, medical officer in the division of parasitic diseases at the Centers for Disease Control and Prevention, Atlanta.

The response to the Web site has been positive, Dr. Nguyen-Dinh said. The clinical guidelines are especially useful, according to 430 physicians surveyed through the Infectious Diseases Society of America's Emerging Infections Network.

The Web site features prevention information, with a link to the CDC's travelers' information site. It also features interactive training for recognition of malaria, including a quiz, sample images, and case studies.

“We know there is a need in the United States for better diagnosis,” said Stephanie Johnson, who is a CDC researcher in the Division of Parasitic Diseases.

In 2002–2003, the CDC received 188 requests for telediagnosis, of which 79 were for suspected malaria. If the telediagnosis is malaria, the CDC requests the sender submit samples for verification.

Health care providers can e-mail images of other suspected parasitic infections to the CDC's Laboratory Identification of Parasites of Public Health Concern program (www.dpd.cdc.gov/dpdx

The Centers for Disease Control and Prevention's malaria hotline, 770-488-7788, operates Monday through Friday, 8 a.m. to 4:30 p.m. EST; the after-hours emergency number is 770-488-7100.

MIAMI BEACH, FLA. — Want to confirm a suspected case of malaria?

You can e-mail a digital image to the Centers for Disease Control and Prevention for telediagnosis.

Then, if your patient requires treatment for malaria, you can download guidelines for treatment from its new malaria Web site, Phuc Nguyen-Dinh, M.D., said at the annual meeting of the American Society of Tropical Medicine & Hygiene.

In less than 1 year, the CDC's online malaria initiative (www.cdc.gov/malaria

Because malaria is relatively rare in the United States, with an estimated 1,200 cases identified per year, clinicians often need assistance in making the diagnosis and deciding on the treatment.

To that end, the CDC offers malaria publications, diagnostic reference services, and training seminars for laboratory personnel.

“Now information is downloadable from the Web site. We believe it is more accurate to print the guidelines than to get information over the telephone. Plus, with the Web site we can update the information as needed,” said Dr. Nguyen-Dinh, medical officer in the division of parasitic diseases at the Centers for Disease Control and Prevention, Atlanta.

The response to the Web site has been positive, Dr. Nguyen-Dinh said. The clinical guidelines are especially useful, according to 430 physicians surveyed through the Infectious Diseases Society of America's Emerging Infections Network.

The Web site features prevention information, with a link to the CDC's travelers' information site. It also features interactive training for recognition of malaria, including a quiz, sample images, and case studies.

“We know there is a need in the United States for better diagnosis,” said Stephanie Johnson, who is a CDC researcher in the Division of Parasitic Diseases.

In 2002–2003, the CDC received 188 requests for telediagnosis, of which 79 were for suspected malaria. If the telediagnosis is malaria, the CDC requests the sender submit samples for verification.

Health care providers can e-mail images of other suspected parasitic infections to the CDC's Laboratory Identification of Parasites of Public Health Concern program (www.dpd.cdc.gov/dpdx

The Centers for Disease Control and Prevention's malaria hotline, 770-488-7788, operates Monday through Friday, 8 a.m. to 4:30 p.m. EST; the after-hours emergency number is 770-488-7100.

MARCO ISLAND, FLA. — Semistructured group therapy improves mood state in HIV-positive men, which improves cortisol levels and immune function and thereby reduces viral load, Karl Goodkin, M.D., said at the annual meeting of the Academy of Psychosomatic Medicine.

Bereavement outside of HIV has long been known to be associated with immunosuppression. Bereavement is also associated with increased mortality risk for surviving partners. The risk increases 40% for the first 6 months and 10-fold in the first year, the same time frame as observed decrements in the immune system, said Dr. Goodkin, who is professor of psychiatry and behavioral sciences, neurology, and psychology at the University of Miami.

In a randomized controlled trial, Dr. Goodkin and his colleagues compared the intervention with usual care in HIV-positive and HIV-negative gay men who had experienced a loss in the previous 6 months.

Although the effects of grief were similar, the two-tier group intervention decreased overall psychological stress—which improved mood and immune measures, including CD4 counts and viral loads—and reduced physician health visits, compared with the usual-care control group, he said.

Participants attended a 90-minute session once weekly for 10 weeks. The groups consisted of 6–10 attendees and two professional coleaders. Enrollment was ongoing throughout the study. The first tier of the intervention fostered grief resolution; the second tier fostered stressor management, including identification of stressor impact and maladaptive behaviors.

In addition to specific grief-related topics for each session, including past experiences of personal loss, reactions to surviving and implications for one's spirituality and mortality, non-bereavement-related stressor management was planned as a major focus of this unique group intervention, he said.

The usual-care group received any medical and psychosocial care that they had begun prior to initial assessment (if used consistently for 1 month or longer). Furthermore, they received four telephone calls during the 10-week intervention period to assess their clinical status. The total time for these calls was limited to 90 minutes over the 10-week period. Study staff avoided any therapeutic interactions during these calls and maintained a log documenting call content.

In the study, 166 participants (97 HIV-positive and 69 HIV-negative) completed the intervention or community usual-care group conditions.

Participants were primarily in their late 30s, employed, and college educated. More than one-third were members of an ethnic minority.

The Stressor-Support-Coping model appears to have utility “with or without bereavement. We found increase in positive life events in HIV-positive men after the intervention. Social support increased in the intervention group and declined in controls,” Dr. Goodkin noted.

The investigators' theoretical model also predicts specific psychosocial treatment needs. If a person has a high life-stressor burden, stressor management would help. If a person has low social support, a social support group would be beneficial. Finally, if a participant demonstrated high passive maladaptive coping or low active coping, coping skills enhancement training would be helpful.

Evidence from the study suggests that increased serum cortisol from stress is associated with decreases in lymphocyte proliferation in response to the artificial stimulant phytohemagglutinin in HIV-positive men and women. This is a functional measure of immunity that tends to decrease before CD4 count, Dr. Goodkin said.

The intervention decreased overall psychological distress in HIV-negative men, compared with controls, according to scores on the Distress-Grief Composite Measure. However, the decreases in grief, specifically, were less prominent than those for distress or the composite of the two measures for both the HIV-positive and -negative men.

In terms of immune effects, HIV-positive people had a true increase in their lymphocyte proliferation response up to 2 years, and the intervention provided HIV-positive participants with a buffer against decreases in CD4 levels seen in controls. The decrement among HIV-positive participants was smaller, compared with HIV-negative groups, where there was a larger spread, Dr. Goodkin explained.

The researchers also looked for an effect at the physical health level. “There was a transition of the neuroendocrine changes to the immune level and, in turn, to the physical health level,” he pointed out.

All participants were asked to self-report physician health care visits in the 6 months prior to assessment; among HIV-positive participants, there was an increase in the control group that was not as great in the intervention group. Researchers found that the same pattern held true among HIV-negative individuals. There was increased health care utilization among control participants and a decrease among the intervention group.

“We did not anticipate this. It indicated that this type of intervention is not only effective for improving the health of HIV-positive people but possibly for the entire population of people who lose a loved one,” he said.

Researchers were not able to analyze whether all health care visits were HIV or symptom related, an important caveat of the study. Another potential limitation was the difference in atmosphere between HIV-positive and HIV-negative group sessions.

“HIV-positive groups talked more about concerns around their own mortality, but nonetheless it is important to note the consistency in findings across multiple domains, especially the physical domains,” Dr. Goodkin said.

“That suggests that if you improve mood state, you will improve cortisol, and you will improve immune function, which relates to improvements in viral load,” he said.

The virology effect of the behavioral intervention was statistically significant, and Dr. Goodkin suggested that “it may never be clinically significant, but we need to look at the latter effect on viral load seen in a subgroup over the long term in larger study groups.”

MARCO ISLAND, FLA. — Semistructured group therapy improves mood state in HIV-positive men, which improves cortisol levels and immune function and thereby reduces viral load, Karl Goodkin, M.D., said at the annual meeting of the Academy of Psychosomatic Medicine.

Bereavement outside of HIV has long been known to be associated with immunosuppression. Bereavement is also associated with increased mortality risk for surviving partners. The risk increases 40% for the first 6 months and 10-fold in the first year, the same time frame as observed decrements in the immune system, said Dr. Goodkin, who is professor of psychiatry and behavioral sciences, neurology, and psychology at the University of Miami.

In a randomized controlled trial, Dr. Goodkin and his colleagues compared the intervention with usual care in HIV-positive and HIV-negative gay men who had experienced a loss in the previous 6 months.

Although the effects of grief were similar, the two-tier group intervention decreased overall psychological stress—which improved mood and immune measures, including CD4 counts and viral loads—and reduced physician health visits, compared with the usual-care control group, he said.

Participants attended a 90-minute session once weekly for 10 weeks. The groups consisted of 6–10 attendees and two professional coleaders. Enrollment was ongoing throughout the study. The first tier of the intervention fostered grief resolution; the second tier fostered stressor management, including identification of stressor impact and maladaptive behaviors.

In addition to specific grief-related topics for each session, including past experiences of personal loss, reactions to surviving and implications for one's spirituality and mortality, non-bereavement-related stressor management was planned as a major focus of this unique group intervention, he said.

The usual-care group received any medical and psychosocial care that they had begun prior to initial assessment (if used consistently for 1 month or longer). Furthermore, they received four telephone calls during the 10-week intervention period to assess their clinical status. The total time for these calls was limited to 90 minutes over the 10-week period. Study staff avoided any therapeutic interactions during these calls and maintained a log documenting call content.

In the study, 166 participants (97 HIV-positive and 69 HIV-negative) completed the intervention or community usual-care group conditions.

Participants were primarily in their late 30s, employed, and college educated. More than one-third were members of an ethnic minority.

The Stressor-Support-Coping model appears to have utility “with or without bereavement. We found increase in positive life events in HIV-positive men after the intervention. Social support increased in the intervention group and declined in controls,” Dr. Goodkin noted.

The investigators' theoretical model also predicts specific psychosocial treatment needs. If a person has a high life-stressor burden, stressor management would help. If a person has low social support, a social support group would be beneficial. Finally, if a participant demonstrated high passive maladaptive coping or low active coping, coping skills enhancement training would be helpful.

Evidence from the study suggests that increased serum cortisol from stress is associated with decreases in lymphocyte proliferation in response to the artificial stimulant phytohemagglutinin in HIV-positive men and women. This is a functional measure of immunity that tends to decrease before CD4 count, Dr. Goodkin said.

The intervention decreased overall psychological distress in HIV-negative men, compared with controls, according to scores on the Distress-Grief Composite Measure. However, the decreases in grief, specifically, were less prominent than those for distress or the composite of the two measures for both the HIV-positive and -negative men.

In terms of immune effects, HIV-positive people had a true increase in their lymphocyte proliferation response up to 2 years, and the intervention provided HIV-positive participants with a buffer against decreases in CD4 levels seen in controls. The decrement among HIV-positive participants was smaller, compared with HIV-negative groups, where there was a larger spread, Dr. Goodkin explained.

The researchers also looked for an effect at the physical health level. “There was a transition of the neuroendocrine changes to the immune level and, in turn, to the physical health level,” he pointed out.

All participants were asked to self-report physician health care visits in the 6 months prior to assessment; among HIV-positive participants, there was an increase in the control group that was not as great in the intervention group. Researchers found that the same pattern held true among HIV-negative individuals. There was increased health care utilization among control participants and a decrease among the intervention group.

“We did not anticipate this. It indicated that this type of intervention is not only effective for improving the health of HIV-positive people but possibly for the entire population of people who lose a loved one,” he said.

Researchers were not able to analyze whether all health care visits were HIV or symptom related, an important caveat of the study. Another potential limitation was the difference in atmosphere between HIV-positive and HIV-negative group sessions.

“HIV-positive groups talked more about concerns around their own mortality, but nonetheless it is important to note the consistency in findings across multiple domains, especially the physical domains,” Dr. Goodkin said.

“That suggests that if you improve mood state, you will improve cortisol, and you will improve immune function, which relates to improvements in viral load,” he said.

The virology effect of the behavioral intervention was statistically significant, and Dr. Goodkin suggested that “it may never be clinically significant, but we need to look at the latter effect on viral load seen in a subgroup over the long term in larger study groups.”

MARCO ISLAND, FLA. — Semistructured group therapy improves mood state in HIV-positive men, which improves cortisol levels and immune function and thereby reduces viral load, Karl Goodkin, M.D., said at the annual meeting of the Academy of Psychosomatic Medicine.

Bereavement outside of HIV has long been known to be associated with immunosuppression. Bereavement is also associated with increased mortality risk for surviving partners. The risk increases 40% for the first 6 months and 10-fold in the first year, the same time frame as observed decrements in the immune system, said Dr. Goodkin, who is professor of psychiatry and behavioral sciences, neurology, and psychology at the University of Miami.

In a randomized controlled trial, Dr. Goodkin and his colleagues compared the intervention with usual care in HIV-positive and HIV-negative gay men who had experienced a loss in the previous 6 months.

Although the effects of grief were similar, the two-tier group intervention decreased overall psychological stress—which improved mood and immune measures, including CD4 counts and viral loads—and reduced physician health visits, compared with the usual-care control group, he said.

Participants attended a 90-minute session once weekly for 10 weeks. The groups consisted of 6–10 attendees and two professional coleaders. Enrollment was ongoing throughout the study. The first tier of the intervention fostered grief resolution; the second tier fostered stressor management, including identification of stressor impact and maladaptive behaviors.

In addition to specific grief-related topics for each session, including past experiences of personal loss, reactions to surviving and implications for one's spirituality and mortality, non-bereavement-related stressor management was planned as a major focus of this unique group intervention, he said.

The usual-care group received any medical and psychosocial care that they had begun prior to initial assessment (if used consistently for 1 month or longer). Furthermore, they received four telephone calls during the 10-week intervention period to assess their clinical status. The total time for these calls was limited to 90 minutes over the 10-week period. Study staff avoided any therapeutic interactions during these calls and maintained a log documenting call content.

In the study, 166 participants (97 HIV-positive and 69 HIV-negative) completed the intervention or community usual-care group conditions.

Participants were primarily in their late 30s, employed, and college educated. More than one-third were members of an ethnic minority.

The Stressor-Support-Coping model appears to have utility “with or without bereavement. We found increase in positive life events in HIV-positive men after the intervention. Social support increased in the intervention group and declined in controls,” Dr. Goodkin noted.

The investigators' theoretical model also predicts specific psychosocial treatment needs. If a person has a high life-stressor burden, stressor management would help. If a person has low social support, a social support group would be beneficial. Finally, if a participant demonstrated high passive maladaptive coping or low active coping, coping skills enhancement training would be helpful.

Evidence from the study suggests that increased serum cortisol from stress is associated with decreases in lymphocyte proliferation in response to the artificial stimulant phytohemagglutinin in HIV-positive men and women. This is a functional measure of immunity that tends to decrease before CD4 count, Dr. Goodkin said.

The intervention decreased overall psychological distress in HIV-negative men, compared with controls, according to scores on the Distress-Grief Composite Measure. However, the decreases in grief, specifically, were less prominent than those for distress or the composite of the two measures for both the HIV-positive and -negative men.

In terms of immune effects, HIV-positive people had a true increase in their lymphocyte proliferation response up to 2 years, and the intervention provided HIV-positive participants with a buffer against decreases in CD4 levels seen in controls. The decrement among HIV-positive participants was smaller, compared with HIV-negative groups, where there was a larger spread, Dr. Goodkin explained.

The researchers also looked for an effect at the physical health level. “There was a transition of the neuroendocrine changes to the immune level and, in turn, to the physical health level,” he pointed out.

All participants were asked to self-report physician health care visits in the 6 months prior to assessment; among HIV-positive participants, there was an increase in the control group that was not as great in the intervention group. Researchers found that the same pattern held true among HIV-negative individuals. There was increased health care utilization among control participants and a decrease among the intervention group.

“We did not anticipate this. It indicated that this type of intervention is not only effective for improving the health of HIV-positive people but possibly for the entire population of people who lose a loved one,” he said.

Researchers were not able to analyze whether all health care visits were HIV or symptom related, an important caveat of the study. Another potential limitation was the difference in atmosphere between HIV-positive and HIV-negative group sessions.

“HIV-positive groups talked more about concerns around their own mortality, but nonetheless it is important to note the consistency in findings across multiple domains, especially the physical domains,” Dr. Goodkin said.

“That suggests that if you improve mood state, you will improve cortisol, and you will improve immune function, which relates to improvements in viral load,” he said.

The virology effect of the behavioral intervention was statistically significant, and Dr. Goodkin suggested that “it may never be clinically significant, but we need to look at the latter effect on viral load seen in a subgroup over the long term in larger study groups.”

MIAMI BEACH—The next edition of “Health Information for International Travel,” also known as the Centers for Disease Control and Prevention's “Yellow Book,” will be more clinically oriented and will include new chapters on specific diseases, such as SARS, according to a sneak preview at the annual meeting of the American Society of Tropical Medicine and Hygiene.

Clinical presentation and treatment information will be added to the new and traditional chapters. Previously, the book addressed only prevention, risk, descriptions, and occurrence of travel-related diseases, according to Christie Reed, M.D., of the CDC's Division of Global Migration and Quarantine.

“Increase in travel was exponential in the 1990s. And the places people were going were different—there was a marked increase in travel to developing parts of the world,” she said. The volume of people migrating around the world also increased significantly, Dr. Reed said, adding, “Yesterday's migrant can become today's traveler.” Many immigrants to the United States return to their countries of origin to visit family and friends, for example, and present unique challenges in travel-related health.

One of the main goals of the CDC's Travelers' Health division is to share information, primarily through the Yellow Book and the Internet (www.cdc.gov/travel

“The Web has been a boon to us in terms of getting information out there quickly. The Yellow Book is out of date every 2 years, but the Web site allows us to be accurate and up to date with rapidly changing information,” Dr. Reed said.

The 2005–2006 edition will include more information from experts outside the CDC and a new bibliography on evidence-based medicine for travelers. New chapters are expected to include:

▸ Norovirus

▸ Severe acute respiratory syndrome

▸ Pneumococcus

▸ Legionella

▸ Jet lag

▸ Fish poisoning

▸ Sunburn

▸ Health-seeking travelers. “This includes people traveling for surgery, dental care, etc. The standards for health care may not be the same in other places as they are in the U.S.,” Dr. Reed said.

There will also be expanded sections on preconception, pregnancy, and breast-feeding issues for travelers. In addition, there will be more information on travel for immunocompromised people, not just for those with HIV infection, as in past editions.

New maps will highlight regions of increased risks associated with Japanese encephalitis and yellow fever.

The 2005–2006 edition is expected to be available in May 2005, to coincide with the 9th Conference of the International Society of Travel Medicine in Lisbon, Portugal.

Although the next edition of the Yellow Book is nearly complete, online information is updated continuously.

Dr. Reed encouraged physicians to submit any travel health-related information or concerns using the “contact us” option on the Web site.

MIAMI BEACH—The next edition of “Health Information for International Travel,” also known as the Centers for Disease Control and Prevention's “Yellow Book,” will be more clinically oriented and will include new chapters on specific diseases, such as SARS, according to a sneak preview at the annual meeting of the American Society of Tropical Medicine and Hygiene.

Clinical presentation and treatment information will be added to the new and traditional chapters. Previously, the book addressed only prevention, risk, descriptions, and occurrence of travel-related diseases, according to Christie Reed, M.D., of the CDC's Division of Global Migration and Quarantine.

“Increase in travel was exponential in the 1990s. And the places people were going were different—there was a marked increase in travel to developing parts of the world,” she said. The volume of people migrating around the world also increased significantly, Dr. Reed said, adding, “Yesterday's migrant can become today's traveler.” Many immigrants to the United States return to their countries of origin to visit family and friends, for example, and present unique challenges in travel-related health.

One of the main goals of the CDC's Travelers' Health division is to share information, primarily through the Yellow Book and the Internet (www.cdc.gov/travel

“The Web has been a boon to us in terms of getting information out there quickly. The Yellow Book is out of date every 2 years, but the Web site allows us to be accurate and up to date with rapidly changing information,” Dr. Reed said.

The 2005–2006 edition will include more information from experts outside the CDC and a new bibliography on evidence-based medicine for travelers. New chapters are expected to include:

▸ Norovirus

▸ Severe acute respiratory syndrome

▸ Pneumococcus

▸ Legionella

▸ Jet lag

▸ Fish poisoning

▸ Sunburn

▸ Health-seeking travelers. “This includes people traveling for surgery, dental care, etc. The standards for health care may not be the same in other places as they are in the U.S.,” Dr. Reed said.

There will also be expanded sections on preconception, pregnancy, and breast-feeding issues for travelers. In addition, there will be more information on travel for immunocompromised people, not just for those with HIV infection, as in past editions.

New maps will highlight regions of increased risks associated with Japanese encephalitis and yellow fever.

The 2005–2006 edition is expected to be available in May 2005, to coincide with the 9th Conference of the International Society of Travel Medicine in Lisbon, Portugal.

Although the next edition of the Yellow Book is nearly complete, online information is updated continuously.

Dr. Reed encouraged physicians to submit any travel health-related information or concerns using the “contact us” option on the Web site.

MIAMI BEACH—The next edition of “Health Information for International Travel,” also known as the Centers for Disease Control and Prevention's “Yellow Book,” will be more clinically oriented and will include new chapters on specific diseases, such as SARS, according to a sneak preview at the annual meeting of the American Society of Tropical Medicine and Hygiene.

Clinical presentation and treatment information will be added to the new and traditional chapters. Previously, the book addressed only prevention, risk, descriptions, and occurrence of travel-related diseases, according to Christie Reed, M.D., of the CDC's Division of Global Migration and Quarantine.

“Increase in travel was exponential in the 1990s. And the places people were going were different—there was a marked increase in travel to developing parts of the world,” she said. The volume of people migrating around the world also increased significantly, Dr. Reed said, adding, “Yesterday's migrant can become today's traveler.” Many immigrants to the United States return to their countries of origin to visit family and friends, for example, and present unique challenges in travel-related health.

One of the main goals of the CDC's Travelers' Health division is to share information, primarily through the Yellow Book and the Internet (www.cdc.gov/travel

“The Web has been a boon to us in terms of getting information out there quickly. The Yellow Book is out of date every 2 years, but the Web site allows us to be accurate and up to date with rapidly changing information,” Dr. Reed said.

The 2005–2006 edition will include more information from experts outside the CDC and a new bibliography on evidence-based medicine for travelers. New chapters are expected to include:

▸ Norovirus

▸ Severe acute respiratory syndrome

▸ Pneumococcus

▸ Legionella

▸ Jet lag

▸ Fish poisoning

▸ Sunburn

▸ Health-seeking travelers. “This includes people traveling for surgery, dental care, etc. The standards for health care may not be the same in other places as they are in the U.S.,” Dr. Reed said.

There will also be expanded sections on preconception, pregnancy, and breast-feeding issues for travelers. In addition, there will be more information on travel for immunocompromised people, not just for those with HIV infection, as in past editions.

New maps will highlight regions of increased risks associated with Japanese encephalitis and yellow fever.

The 2005–2006 edition is expected to be available in May 2005, to coincide with the 9th Conference of the International Society of Travel Medicine in Lisbon, Portugal.

Although the next edition of the Yellow Book is nearly complete, online information is updated continuously.

Dr. Reed encouraged physicians to submit any travel health-related information or concerns using the “contact us” option on the Web site.

MARCO ISLAND, FLA. — An intervention significantly increases depression-free days and improves physical functioning in the elderly—even 12 months later, Wayne J. Katon, M.D., reported at the annual meeting of the Academy of Psychosomatic Medicine.

New 2-year data from the Improving Mood—Promoting Access to Collaborative Treatment for Late Life Depression (IMPACT) study show that the clinical benefits of the intervention persist well beyond the initial 1-year treatment period.

“We saw improvements in functioning, pain, and overall quality of life,” said Dr. Katon, a psychiatrist at the University of Washington, Seattle. “We were surprised at that the extent of the benefit in year 2, which was equal to the benefit we found in year 1.”

In addition, the intervention proved cost effective at most of the sites. (See box.)

An estimated 10%–20% of older primary care patients meet the criteria for depression, and the percentage increases to up to 25% with chronic illness. But few depressed elderly patients receive appropriate care because of the burden of comorbidities, poor physical function, and often “an understanding” that they are depressed because of those comorbidities, said Dr. Katon, professor, vice chair, and director of the division of health services and psychiatric epidemiology at the university.

An initial report on IMPACT—a multicenter study of 1,801 depressed older adults—had shown that 45% of the 906 patients randomized to the intervention group had a 50% or greater improvement in depressive symptoms at 12 months (JAMA 2002;288:2836–45). In contrast, only 19% of the 895 patients randomized to usual care showed the same level of improvement.

The researchers recruited patients from 18 primary care clinics in five states. The participants were 66% female and 24% nonwhite, and all were 60 years or older (mean age 71). Many met criteria for major depression (17%), dysthymia (30%), or both (53%). Participants had a mean of 3.2 chronic illnesses, which included chronic pain, osteoarthritis, incontinence, and diabetes.

“A lot of these people would not be admitted into other depression studies because of the extent of their comorbidities,” Dr. Katon said.

Participants randomized to the intervention group had access to a dedicated depression care manager. This manager provided education, behavioral activation, support of antidepressant therapy (prescribed by the patients' primary care physicians), or brief psychotherapy using the Problem Solving Treatment in Primary Care protocol. Depression care managers tracked outcomes using the depression module of the Patient Health Questionnaire (PHQ-9) and adjusted treatment accordingly.

“Stepped care allowed us to add an antidepressant if needed or to add psychotherapy as needed,” Dr. Katon explained.

Physicians for patients in the usual care group were only told that the patient met criteria for depression or dysthymia. Physicians in the usual care arm could start patients on antidepressants or refer for psychotherapy or medication.

Patients were assessed at baseline and at 3, 6, 12, and 24 months. By 1 year, the intervention group was more likely to get some antidepressant treatment (odds ratio 2.98) and report more satisfaction with depression care (OR 3.38). Intervention patients got better more quickly over the 12-month period, he added.

Dr. Katon, lead investigator Jürgen Unützer, M.D., (professor of psychiatry at the university), and their colleagues followed patients for an additional year after the intervention.

In other studies that included mixed-age patients, the 12-month intervention versus usual care differences tended to come together, Dr. Katon said. But in the elderly population, the usual care patients improved for about 6 months, and then their improvements reached a plateau, whereas the intervention group did gradually better during the entire 24 months.

The intervention group patients had 107 additional depression-free days, compared with the usual care patients. “That is about a one-third-of-a-year difference,” Dr. Katon said.

“We're sorry we did not take this study to a third year, since we saw equal benefit in intervention, compared with usual care patients in the second year,” he said.

Of the 107 depression-free days gained by the intervention group, 53 were in the first year, and 54 were in the second.

The John A. Hartman Foundation and the California HealthCare Foundation funded the IMPACT study.

Visit www.impact.ucla.edu

Intervention Proves Cost Effective

The IMPACT researchers calculated total outpatient costs as $11,083 in the usual care group, compared with $11,378 in the intervention group.

Thus, there is an increase of $295 in the intervention group over 24 months. In year 1, there was $383 more in ambulatory costs for intervention patients, compared with usual care—but in year 2, there was an $88 cost savings associated with the intervention.

“For a small bump in cost, you get 53 depression-free days in year 1, and in the second year, you actually save money for the 54 days [gained],” Dr. Katon said.

To ascertain total costs, the researchers considered the cost of usual care as $0 for reference and calculated intervention-specific costs as a mean $591 per patient over the 2 years. Comparing other mean costs for intervention group vs. usual care, antidepressant medication was $416 higher for intervention patients; other medication costs were $126 lower (a net savings); outpatient specialty mental health care was $86 lower; and other outpatient costs were $501 lower for intervention patients.

Intervention-specific costs included psychiatrist and primary care supervision time, nurse time, overhead costs, and educational materials. Other ambulatory medical costs included primary care and specialty visits, emergency department use, urgent care visits, and laboratory and imaging charges. Researchers excluded costs of inpatient care and patient time. The cost of patient time is “difficult to do in the elderly, because most are not working,” he said.

Some figures were estimated. For example, 17%–24% of health care data were not available, Dr. Katon said. In addition, some organizations did not have pharmacy data. In cases where data were missing, imputation—which estimates costs by considering demographics, prior health care use, and other factors—was used to estimate costs.

The researchers estimated the incremental cost per quality-adjusted life year (QALY) for the intervention group. The range was $2,521 to $5,000. “It is widely accepted that anything that is under $10,000 per QALY for health care should be implemented immediately,” Dr. Katon said.

New interventions typically cost more with increased effectiveness, Dr. Katon said. “The holy grail is that an intervention that costs less with increased effectiveness should be implemented immediately.” For three of the eight organizations, the intervention saved money over the 2 years, with greater benefit, he added.

Reimbursement for collaborative care remains an issue. Psychiatrist supervision with the primary care physicians and depression care manager was not reimbursable, nor were the depression care manager's consultations with other providers (nonpatient treatment time). Follow-up telephone calls, likewise, were not reimbursed.

Despite the reimbursement issues, interest in the IMPACT model has been strong. “We're getting called all the time from health care organizations all over the United States with questions about how to implement this,” Dr. Katon said.

MARCO ISLAND, FLA. — An intervention significantly increases depression-free days and improves physical functioning in the elderly—even 12 months later, Wayne J. Katon, M.D., reported at the annual meeting of the Academy of Psychosomatic Medicine.

New 2-year data from the Improving Mood—Promoting Access to Collaborative Treatment for Late Life Depression (IMPACT) study show that the clinical benefits of the intervention persist well beyond the initial 1-year treatment period.

“We saw improvements in functioning, pain, and overall quality of life,” said Dr. Katon, a psychiatrist at the University of Washington, Seattle. “We were surprised at that the extent of the benefit in year 2, which was equal to the benefit we found in year 1.”

In addition, the intervention proved cost effective at most of the sites. (See box.)

An estimated 10%–20% of older primary care patients meet the criteria for depression, and the percentage increases to up to 25% with chronic illness. But few depressed elderly patients receive appropriate care because of the burden of comorbidities, poor physical function, and often “an understanding” that they are depressed because of those comorbidities, said Dr. Katon, professor, vice chair, and director of the division of health services and psychiatric epidemiology at the university.

An initial report on IMPACT—a multicenter study of 1,801 depressed older adults—had shown that 45% of the 906 patients randomized to the intervention group had a 50% or greater improvement in depressive symptoms at 12 months (JAMA 2002;288:2836–45). In contrast, only 19% of the 895 patients randomized to usual care showed the same level of improvement.

The researchers recruited patients from 18 primary care clinics in five states. The participants were 66% female and 24% nonwhite, and all were 60 years or older (mean age 71). Many met criteria for major depression (17%), dysthymia (30%), or both (53%). Participants had a mean of 3.2 chronic illnesses, which included chronic pain, osteoarthritis, incontinence, and diabetes.

“A lot of these people would not be admitted into other depression studies because of the extent of their comorbidities,” Dr. Katon said.

Participants randomized to the intervention group had access to a dedicated depression care manager. This manager provided education, behavioral activation, support of antidepressant therapy (prescribed by the patients' primary care physicians), or brief psychotherapy using the Problem Solving Treatment in Primary Care protocol. Depression care managers tracked outcomes using the depression module of the Patient Health Questionnaire (PHQ-9) and adjusted treatment accordingly.

“Stepped care allowed us to add an antidepressant if needed or to add psychotherapy as needed,” Dr. Katon explained.

Physicians for patients in the usual care group were only told that the patient met criteria for depression or dysthymia. Physicians in the usual care arm could start patients on antidepressants or refer for psychotherapy or medication.

Patients were assessed at baseline and at 3, 6, 12, and 24 months. By 1 year, the intervention group was more likely to get some antidepressant treatment (odds ratio 2.98) and report more satisfaction with depression care (OR 3.38). Intervention patients got better more quickly over the 12-month period, he added.

Dr. Katon, lead investigator Jürgen Unützer, M.D., (professor of psychiatry at the university), and their colleagues followed patients for an additional year after the intervention.

In other studies that included mixed-age patients, the 12-month intervention versus usual care differences tended to come together, Dr. Katon said. But in the elderly population, the usual care patients improved for about 6 months, and then their improvements reached a plateau, whereas the intervention group did gradually better during the entire 24 months.

The intervention group patients had 107 additional depression-free days, compared with the usual care patients. “That is about a one-third-of-a-year difference,” Dr. Katon said.

“We're sorry we did not take this study to a third year, since we saw equal benefit in intervention, compared with usual care patients in the second year,” he said.

Of the 107 depression-free days gained by the intervention group, 53 were in the first year, and 54 were in the second.

The John A. Hartman Foundation and the California HealthCare Foundation funded the IMPACT study.

Visit www.impact.ucla.edu

Intervention Proves Cost Effective

The IMPACT researchers calculated total outpatient costs as $11,083 in the usual care group, compared with $11,378 in the intervention group.

Thus, there is an increase of $295 in the intervention group over 24 months. In year 1, there was $383 more in ambulatory costs for intervention patients, compared with usual care—but in year 2, there was an $88 cost savings associated with the intervention.

“For a small bump in cost, you get 53 depression-free days in year 1, and in the second year, you actually save money for the 54 days [gained],” Dr. Katon said.

To ascertain total costs, the researchers considered the cost of usual care as $0 for reference and calculated intervention-specific costs as a mean $591 per patient over the 2 years. Comparing other mean costs for intervention group vs. usual care, antidepressant medication was $416 higher for intervention patients; other medication costs were $126 lower (a net savings); outpatient specialty mental health care was $86 lower; and other outpatient costs were $501 lower for intervention patients.

Intervention-specific costs included psychiatrist and primary care supervision time, nurse time, overhead costs, and educational materials. Other ambulatory medical costs included primary care and specialty visits, emergency department use, urgent care visits, and laboratory and imaging charges. Researchers excluded costs of inpatient care and patient time. The cost of patient time is “difficult to do in the elderly, because most are not working,” he said.

Some figures were estimated. For example, 17%–24% of health care data were not available, Dr. Katon said. In addition, some organizations did not have pharmacy data. In cases where data were missing, imputation—which estimates costs by considering demographics, prior health care use, and other factors—was used to estimate costs.

The researchers estimated the incremental cost per quality-adjusted life year (QALY) for the intervention group. The range was $2,521 to $5,000. “It is widely accepted that anything that is under $10,000 per QALY for health care should be implemented immediately,” Dr. Katon said.

New interventions typically cost more with increased effectiveness, Dr. Katon said. “The holy grail is that an intervention that costs less with increased effectiveness should be implemented immediately.” For three of the eight organizations, the intervention saved money over the 2 years, with greater benefit, he added.

Reimbursement for collaborative care remains an issue. Psychiatrist supervision with the primary care physicians and depression care manager was not reimbursable, nor were the depression care manager's consultations with other providers (nonpatient treatment time). Follow-up telephone calls, likewise, were not reimbursed.

Despite the reimbursement issues, interest in the IMPACT model has been strong. “We're getting called all the time from health care organizations all over the United States with questions about how to implement this,” Dr. Katon said.

MARCO ISLAND, FLA. — An intervention significantly increases depression-free days and improves physical functioning in the elderly—even 12 months later, Wayne J. Katon, M.D., reported at the annual meeting of the Academy of Psychosomatic Medicine.

New 2-year data from the Improving Mood—Promoting Access to Collaborative Treatment for Late Life Depression (IMPACT) study show that the clinical benefits of the intervention persist well beyond the initial 1-year treatment period.

“We saw improvements in functioning, pain, and overall quality of life,” said Dr. Katon, a psychiatrist at the University of Washington, Seattle. “We were surprised at that the extent of the benefit in year 2, which was equal to the benefit we found in year 1.”

In addition, the intervention proved cost effective at most of the sites. (See box.)

An estimated 10%–20% of older primary care patients meet the criteria for depression, and the percentage increases to up to 25% with chronic illness. But few depressed elderly patients receive appropriate care because of the burden of comorbidities, poor physical function, and often “an understanding” that they are depressed because of those comorbidities, said Dr. Katon, professor, vice chair, and director of the division of health services and psychiatric epidemiology at the university.

An initial report on IMPACT—a multicenter study of 1,801 depressed older adults—had shown that 45% of the 906 patients randomized to the intervention group had a 50% or greater improvement in depressive symptoms at 12 months (JAMA 2002;288:2836–45). In contrast, only 19% of the 895 patients randomized to usual care showed the same level of improvement.

The researchers recruited patients from 18 primary care clinics in five states. The participants were 66% female and 24% nonwhite, and all were 60 years or older (mean age 71). Many met criteria for major depression (17%), dysthymia (30%), or both (53%). Participants had a mean of 3.2 chronic illnesses, which included chronic pain, osteoarthritis, incontinence, and diabetes.

“A lot of these people would not be admitted into other depression studies because of the extent of their comorbidities,” Dr. Katon said.

Participants randomized to the intervention group had access to a dedicated depression care manager. This manager provided education, behavioral activation, support of antidepressant therapy (prescribed by the patients' primary care physicians), or brief psychotherapy using the Problem Solving Treatment in Primary Care protocol. Depression care managers tracked outcomes using the depression module of the Patient Health Questionnaire (PHQ-9) and adjusted treatment accordingly.

“Stepped care allowed us to add an antidepressant if needed or to add psychotherapy as needed,” Dr. Katon explained.

Physicians for patients in the usual care group were only told that the patient met criteria for depression or dysthymia. Physicians in the usual care arm could start patients on antidepressants or refer for psychotherapy or medication.

Patients were assessed at baseline and at 3, 6, 12, and 24 months. By 1 year, the intervention group was more likely to get some antidepressant treatment (odds ratio 2.98) and report more satisfaction with depression care (OR 3.38). Intervention patients got better more quickly over the 12-month period, he added.

Dr. Katon, lead investigator Jürgen Unützer, M.D., (professor of psychiatry at the university), and their colleagues followed patients for an additional year after the intervention.

In other studies that included mixed-age patients, the 12-month intervention versus usual care differences tended to come together, Dr. Katon said. But in the elderly population, the usual care patients improved for about 6 months, and then their improvements reached a plateau, whereas the intervention group did gradually better during the entire 24 months.

The intervention group patients had 107 additional depression-free days, compared with the usual care patients. “That is about a one-third-of-a-year difference,” Dr. Katon said.

“We're sorry we did not take this study to a third year, since we saw equal benefit in intervention, compared with usual care patients in the second year,” he said.

Of the 107 depression-free days gained by the intervention group, 53 were in the first year, and 54 were in the second.

The John A. Hartman Foundation and the California HealthCare Foundation funded the IMPACT study.

Visit www.impact.ucla.edu

Intervention Proves Cost Effective

The IMPACT researchers calculated total outpatient costs as $11,083 in the usual care group, compared with $11,378 in the intervention group.

Thus, there is an increase of $295 in the intervention group over 24 months. In year 1, there was $383 more in ambulatory costs for intervention patients, compared with usual care—but in year 2, there was an $88 cost savings associated with the intervention.

“For a small bump in cost, you get 53 depression-free days in year 1, and in the second year, you actually save money for the 54 days [gained],” Dr. Katon said.

To ascertain total costs, the researchers considered the cost of usual care as $0 for reference and calculated intervention-specific costs as a mean $591 per patient over the 2 years. Comparing other mean costs for intervention group vs. usual care, antidepressant medication was $416 higher for intervention patients; other medication costs were $126 lower (a net savings); outpatient specialty mental health care was $86 lower; and other outpatient costs were $501 lower for intervention patients.

Intervention-specific costs included psychiatrist and primary care supervision time, nurse time, overhead costs, and educational materials. Other ambulatory medical costs included primary care and specialty visits, emergency department use, urgent care visits, and laboratory and imaging charges. Researchers excluded costs of inpatient care and patient time. The cost of patient time is “difficult to do in the elderly, because most are not working,” he said.

Some figures were estimated. For example, 17%–24% of health care data were not available, Dr. Katon said. In addition, some organizations did not have pharmacy data. In cases where data were missing, imputation—which estimates costs by considering demographics, prior health care use, and other factors—was used to estimate costs.

The researchers estimated the incremental cost per quality-adjusted life year (QALY) for the intervention group. The range was $2,521 to $5,000. “It is widely accepted that anything that is under $10,000 per QALY for health care should be implemented immediately,” Dr. Katon said.

New interventions typically cost more with increased effectiveness, Dr. Katon said. “The holy grail is that an intervention that costs less with increased effectiveness should be implemented immediately.” For three of the eight organizations, the intervention saved money over the 2 years, with greater benefit, he added.

Reimbursement for collaborative care remains an issue. Psychiatrist supervision with the primary care physicians and depression care manager was not reimbursable, nor were the depression care manager's consultations with other providers (nonpatient treatment time). Follow-up telephone calls, likewise, were not reimbursed.

Despite the reimbursement issues, interest in the IMPACT model has been strong. “We're getting called all the time from health care organizations all over the United States with questions about how to implement this,” Dr. Katon said.